Ovarian Cancer

  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:73e17bcc1a94ebd672b913e6684b1727' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>RATIONALE: Palifermin may help relieve or prevent oral mucositis caused by chemotherapy and radiation therapy in young patients undergoing stem cell transplant. PURPOSE: This randomized phase II trial is studying palifermin to see how well it works compared with a placebo in preventing oral mucositis caused by chemotherapy and/or radiation therapy in young patients undergoing stem cell transplant.</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:73e17bcc1a94ebd672b913e6684b1727' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>A Group-Wide Double-Blind Randomized Placebo-Controlled Trial of Palifermin to Prevent Chemotherapy and/or Radiotherapy Induced Oral Mucositis in Children Undergoing Autologous or Allogeneic Hematopoietic Stem Cell Transplantation</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:df5f8ae469adb8470aa30e5df7c98a46' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>OBJECTIVES: Primary\n<ul>\n<li>To compare whether palifermin versus placebo administered to pediatric patients three days prior to conditioning and three days after autologous or allogeneic hematopoietic stem cell transplantation (HSCT) is associated with a reduction in the incidence of WHO grade 3 or 4 oral mucositis.</li>\n</ul>\n</p><p> Secondary\n<ul>\n<li>To evaluate the safety and tolerability of palifermin.</li>\n<li>To evaluate the long-term effects of palifermin on disease outcome and survival.</li>\n<li>To compare the incidence, total dose, and duration of parenteral opioid analgesic use (morphine equivalents), and incidence and duration of total parenteral nutrition (TPN) administration in patients treated with these regimens.</li>\n<li>To compare the incidence of febrile neutropenia and invasive bacterial infections in patients treated with these regimens.</li>\n<li>To determine whether palifermin versus placebo reduces the incidence of WHO grade 3 or 4 oral mucositis among allogeneic HSCT pediatric patients receiving methotrexate as graft-versus-host disease (GVHD) prophylaxis.</li>\n<li>To determine whether palifermin versus placebo reduces acute and chronic GVHD after allogeneic HSCT.</li>\n<li>To describe health care utilization (hospitalization duration, and administration of antibiotics, TPN, nasogastric-, nasojejunal- or gastrostomy-administered enteral nutrition, and blood products) in pediatric patients treated with these regimens.</li>\n</ul>\n</p><p> OUTLINE: This is a multicenter study. Patients are stratified according to age in years (1 to 2 vs 3 to 11 vs 12 to 16), type of hematopoietic stem cell transplantation (HSCT) (autologous vs allogeneic), conditioning regimen (either total-body irradiation [TBI] or melphalan vs neither TBI nor melphalan). Patients are randomized to 1 of 2 treatment arms.\n<ul>\n<li>Arm I: Patients receive palifermin IV once daily for 3 days prior to chemotherapy and/or radiotherapy in the absence of unacceptable toxicity.</li>\n</ul>\n</p><p> Patients then receive palifermin IV on days 0, 1, and 2 after autologous or allogeneic HSCT.\n<ul>\n<li>Arm II: Patients receive placebo IV once daily for 3 days prior to chemotherapy and/or radiotherapy in the absence of unacceptable toxicity. Patients then receive placebo IV on days 0, 1, and 2 after autologous or allogeneic HSCT.</li>\n</ul>\n</p><p> Blood samples are collected at baseline, 32 days, and 100 days after HSCT to evaluate the immunogenicity of palifermin. Oral mucositis is assessed at baseline, daily for 8 days prior to and 32 days after HSCT, or until oral mucositis has resolved by the WHO Mucositis Scale, Oral Mucositis Assessment Scale (OMAS), modified Walsh mucositis scale, Oral Mucositis Daily Questionnaire (OMDQ), and the pain categorical rating scale. After completion of HSCT, patients are followed periodically for up to 10 years.</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:a35da0cfa0a7a86f6409af67c4b7bd98' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>DISEASE CHARACTERISTICS:\n<ul>\n<li>Patients undergoing myeloablative autologous or allogeneic hematopoietic stem cell transplantation (HSCT) for any indication</li>\n<li>Any type of myeloablative HSCT conditioning regimen allowed</li>\n<li>Patients undergoing allogeneic HSCT may undergo 1 of the following types of donor stem cells:\n<ul>\n<li>HLA-matched sibling or parent</li>\n<li>Partially matched family donor (mismatched for a single HLA locus [class I])</li>\n<li>Fully matched unrelated marrow or peripheral blood stem cell donor</li>\n<li>HLA-matched or partially mismatched (at least 4 of 6 match) cord blood (class I or II)</li>\n</ul>\n</li>\n</ul>\n</p><p> PATIENT CHARACTERISTICS:\n<ul>\n<li>Not pregnant or nursing</li>\n<li>Negative pregnancy test</li>\n<li>Fertile patients must use effective contraception</li>\n<li>No HIV positivity</li>\n<li>No known sensitivity to any E. coli-derived products\n<ul>\n<li>Known grade 1 to 2 allergic reactions to asparaginase allowed</li>\n<li>No prior grade 3-4 allergies to asparaginase or pegaspargase</li>\n</ul>\n</li>\n</ul>\n</p><p> PRIOR CONCURRENT THERAPY:\n<ul>\n<li>See Disease Characteristics</li>\n<li>More than 30 days since prior and no concurrent treatment with any of the following therapies:\n<ul>\n<li>Oral cryotherapy</li>\n<li>Glutamine as an oral supplement</li>\n<li>Traumeel&#174;</li>\n<li>Gelclair&#174;</li>\n<li>Oral vancomycin paste</li>\n<li>Low-level laser therapy</li>\n<li>An investigational product or device in another clinical trial</li>\n</ul>\n</li>\n<li>No prior palifermin or other keratinocyte growth factors</li>\n<li>No other concurrent cytotoxic drugs for conditioning or graft-vs-host disease prophylaxis\n<ul>\n<li>Intrathecal methotrexate or cytarabine for CNS involvement allowed</li>\n</ul>\n</li>\n</ul>\n</p>', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:bb95235845e20e6a675762a6d3f40d7e' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Safety and tolerability of palifermin [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:ec6dbdc887d16cd51563c4748d35fa7e' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Duration of WHO grade 3 or 4 oral mucositis [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:0ba2af343f300b31fc7e925de958cb39' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Incidence, total dose, and duration of parenteral opioid analgesic use (morphine equivalents) [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:efda079bce71216266982e184ec19e9c' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Incidence and duration of total parenteral nutrition administration [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:02fac6ce9cae062f7b8ef9c212258471' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Incidence of WHO grade 3 or 4 oral mucositis among allogeneic HSCT patients receiving methotrexate as GVHD prophylaxis [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:a24c53e1e9c2beb430185cc3a2a2a849' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Incidence of acute and chronic GVHD after allogeneic HSCT [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:4d84bcb8e25523003f9e0c8a53ba6cfa' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The purpose of this study is to asses the impact of a tailored preoperative psychological intervention on women with gynecological malignancies on psychological, physiological and immunological parameters</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:607cfddfbd873bc2847f6b747f213b8f' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Assessment of the Impact of Preoperative Stress Reduction on Psychological, Physiological and Immunological Parameters in Women With Gynecological Malignancies - Prospective Randomized Controlled Trial</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:57889d6a453e109ac19ad3cb75cb0a28' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Surgery is considered one of the most stressful events in human life. Research indicates that patients show high levels of stress from at least six days before surgery and up to a week post the operation. Stress levels return to normalcy only after several weeks. Research shows that psychological interventions given to women suffering from cancer can improve their coping abilities and overall function, decreases stress levels, enhances adherence to treatments,and increases quality of life and even life expectancy. Women enrolled in this study will be divided into two groups: an experimental group and a control group. Both groups will receive standard care. The control group will interact with a nurse for one hour. The experimental group will receive one of two forms of psychological intervention: either a cognitive intervention, or a psychophysiological intervention (tailored to each woman). Measurements and Instruments include: 1) Self-report questionnaires, such as:Profile of Mood States (POMS-SF),Coping Inventory (COPE), Life Orientation Test Revised (LOT- R),Stress Level Report, 2) Demographics, 3) Global assessment by the head nurse. 4)Physiological and behavioral measures, such as: vital signs and use of medicine. 5)Hormonal and immunological measures: levels of cortisol in saliva and plasma, levels of catecholamines in plasma, salivary levels of IgA1, and peripheral blood NK cells and lymphocyte phenotyping.6)levels of cytokines including IL-1,2,4,6,10,12, TNF-alpha, Interferon-gamma. Time intervals for the collection of blood and saliva and the administration of the questionnaires: During the first week after being given the diagnosis and prior to the intervention:Blood &amp; saliva, Stress Level Report, POMS-SF, COPE, LOT-R A day prior to surgery:Blood &amp; saliva, Stress Level Report On discharge from hospital:Blood &amp; saliva, Stress Level Report 30 days after surgery:Stress Level Report,POMS-SF,COPE,LOT-R.</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:67c75ed3ef9d3cccbd289c1ec6b639a5' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Woman with ovarian, cervical or endometrial cancer/tumor</li>\n<li>Women who speak Hebrew</li>\n<li>Women who sign the consent form</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Women who have received neoadjuvant treatment</li>\n<li>Women suffering from any form of depression, anxiety or schizophrenia</li>\n<li>Women suffering from autoimmune or infectious diseases</li>\n<li>Women taking medications which have immunological effects (steroids ,beta-blockers)</li>\n<li>Women suffering from dementia or concentration problems</li>\n</ul>\n</p>', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:52cb96c69802a5c6ef89d9cbb81580be' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The objective of this study is to compare progression-free survival (PFS) in subjects with platinum-resistant ovarian cancer who receive combination therapy with EC145 and pegylated liposomal doxorubicin (PLD/Doxil&#174;/Caelyx&#174;)versus PLD alone.</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:fac9a73372736e70339abde4cd562a14' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>A Randomized Phase II Trial Comparing EC145 and Pegylated Liposomal Doxorubicin (PLD/Doxil/Caelyx) in Combination, Versus PLD Alone, in Subjects With Platinum-Resistant Ovarian Cancer</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:74d88b3c4b865cd1b2965fb920aa6e1b' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This is a Phase II clinical trial to evaluate the efficacy and safety of the combination of EC145 and pegylated liposomal doxorubicin (PLD; available in the United States as Doxil&#174; and outside the United States as Caelyx&#174;) compared to PLD alone. EC145 is a drug that is specifically designed to enter cancer cells via the folate vitamin receptor (FR). Experimental evidence shows that this target receptor is expressed on virtually all ovarian cancers. Early clinical evidence in a small number of Phase I subjects and in a subset of subjects in an on-going single-arm Phase II study suggests that EC145 may have antitumor effect in women with advanced ovarian cancer and that it is generally well-tolerated. This evidence suggests that EC145 may be useful as chemotherapy against advanced ovarian cancer. All patients with measurable disease will also undergo imaging with the FR-targeting investigational diagnostic agent EC20 (FolateScan) during the screening period to assess uptake of this agent into tumors. This non-invasive procedure will provide additional information on the utility of EC20 imaging to identify subjects with the FR molecular &quot;target&quot; before treatment with EC145 therapy.</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:be84ce957f0077bd6b2ad405ba35e9e1' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria: To qualify for randomization and treatment the following criteria must be met:\n<ul>\n<li>Subjects must sign an approved informed consent form</li>\n<li>Subjects must be &#8805; 18 years of age</li>\n<li>Subjects must have pathology confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma</li>\n<li>Subjects must have platinum-resistant ovarian cancer, where platinum-resistant is defined as disease that responded to primary platinum therapy and then progressed within 6 months or disease that progressed during or within 6 months of completing secondary platinum therapy</li>\n<li>Subjects must have either one or both of the following:\n<ol>\n<li>At least a single measurable lesion (by RECIST criteria) on a radiological evaluation that is conducted no more than 4 weeks prior to beginning study therapy (EC145 and/or PLD), or</li>\n<li>Screening CA-125 &#8805; 2 x upper limit of normal (ULN)</li>\n</ol>\n</li>\n<li>Subjects must have had prior debulking surgery</li>\n<li>Subjects must have received prior platinum-based chemotherapy but must not have received more than 2 prior systemic cytotoxic regimens. Subjects are allowed to receive, but are not required to receive, one additional non-cytotoxic regimen for the management of recurrent or persistent disease.</li>\n</ul>\n</p><p> Non-cytotoxic (biologic or cytostatic) agents include, but are not limited to, monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction.\n<ul>\n<li>Subjects must have an ECOG performance status of 0 to 2</li>\n<li>Subjects must have recovered (to baseline/stabilization) from prior cytotoxic therapy-associated acute toxicities. Subjects who have recovered from non-cytotoxic therapy-associated toxicity or who have &quot;controlled&quot; non-cytotoxic therapy toxicity (e.g., vascular endothelial growth factor-related hypertension) can be entered into the trial after a drug wash-out period of 4 half lives</li>\n<li>Subjects must have adequate organ function including:\n<ol>\n<li>Bone Marrow Reserve: Absolute neutrophil count(ANC)&#8805; 1.5x10^9/L prior to treatment. Subjects on maintenance doses of G-CSF are eligible. Platelets\n<ul>\n<li>100x10^9/L and hemoglobin &#8805; 9 g/dL.</li>\n</ul>\n</li>\n<li>Hepatic: Total bilirubin level &lt; 1.5 x ULN and alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase(GGT), and alkaline phosphatase levels &lt; 2.5 x ULN.</li>\n<li>Renal: Serum creatinine level &#8804; 1.5 x ULN or creatinine clearance &#8805; 50 mL/min/1.73m^2 for subjects with serum creatinine levels above 1.5 x ULN.</li>\n<li>Cardiac: Left ventricular ejection fraction (LVEF) equal to or greater than the institutional lower limit of normal. LVEF must be elevated within 90 days prior to C1D1.</li>\n</ol>\n</li>\n<li>Subjects of childbearing potential must:\n<ol>\n<li>Have a negative serum pregnancy test prior to initiation of the therapeutic regimen</li>\n<li>Practice an effective method of birth control (e.g., oral, transdermal or injectable contraceptives, intrauterine device, double-barrier contraception, such as diaphragm and spermicidal jelly) for the duration of their participation in the trial through 3 months following the last dose of study drug.</li>\n</ol>\n</li>\n</ul>\n</p><p> Exclusion Criteria: The presence of any of the following will exclude the subject from the study:\n<ul>\n<li>Diagnosis of tumor of low-malignant potential</li>\n<li>Prior exposure to PLD or anthracycline therapy</li>\n<li>Prior exposure to FR-targeted therapy (EC145, EC0225, farletuzumab, etc)</li>\n<li>Prior therapy with mouse antibodies</li>\n<li>Prior therapy with vinorelbine (Navelbine&#174;) or vinca-containing compounds</li>\n<li>Prior abdominal or pelvic radiation therapy, radiation therapy to &gt; 10% of the bone marrow, or prior radiation therapy within the past 3 years to the breast/sternum, dermal lesions, head or neck</li>\n<li>Recent (i.e., &#8804; 6 weeks) history of abdominal surgery or peritonitis</li>\n<li>Serious comorbidities (as determined by the investigator) such as, but not limited to, active congestive heart failure or recent myocardial infarction. Subjects who require antifolate therapy for the management of comorbid conditions (e.g., rheumatoid arthritis) will be excluded from the trial.</li>\n<li>Pregnancy</li>\n<li>Concurrent malignancy or history of other cancer (except noninvasive skin cancer) within the last 5 years</li>\n<li>Symptomatic central nervous system metastasis</li>\n<li>Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational (i.e., used for non-approved indications(s) and in the context of a research investigation). Use of low dose corticosteroid therapy (for nausea prophylaxis, etc) is acceptable; however, concomitant tamoxifen therapy is not. Supportive care measures are allowed.</li>\n</ul>\n</p>', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:ee0b1dd4c89c42b890dc9e2cc42aac4f' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Compare overall survival between the two treatment arms [&nbsp;Time&nbsp;Frame:&nbsp;Assessed at 18 months after initiation of PFS analysis&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:e234514fe32596f77ff3507597afd4e6' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:4d48042f9a47aa58833bb44f9bc2a450' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Evaluate the safety and tolerability of EC145 in combination with PLD [&nbsp;Time&nbsp;Frame:&nbsp;event driven&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:4d48042f9a47aa58833bb44f9bc2a450' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:20b34ad1d50fc0895b0bde28c2ef3b43' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Compare objective response rate based on investigator assessment when analyzed using GCIG criteria and RECIST [&nbsp;Time&nbsp;Frame:&nbsp;event-driven&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:20b34ad1d50fc0895b0bde28c2ef3b43' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:9a2b0d8357d7836eb8352dce726a9d4a' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Compare duration of response when analyzed using GCIG criteria and RECIST [&nbsp;Time&nbsp;Frame:&nbsp;event-driven&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:9a2b0d8357d7836eb8352dce726a9d4a' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:5650289547ee540364ac5715ce9953b8' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This study is based on the finding that tumor cells that are grown in the laboratory can be modified in such a way that, when injected to the patient, they will stimulate his/her immune response. This approach will be evaluated in patients with colorectal, gastric, ovarian, breast or lung epithelial cancer. Tumor cells grown in the laboratory will be modified to make them stimulatory to the immune system, irradiated to kill them, and injected to the patient eight times at two-week intervals . This protocol is expected to prolong survival of metastatic epithelial cancer patients.</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:5650289547ee540364ac5715ce9953b8' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>&nbsp;</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>&nbsp;</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:52d0208a94ed93feaea61fa51f692e38' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Metastatic epithelial cancer</li>\n<li>Above 18 years of age</li>\n<li>Failure of at least one chemotherapy protocol</li>\n<li>Clinical performance status of ECOG 0,1</li>\n<li>Absolute neutrophil count greater than 1000/mm3</li>\n<li>Serum ALT/AST less than three times the upper limit of normal</li>\n<li>Serum creatinine less than or equal to 1.6 mg/dl.</li>\n<li>Must be able to understand and sign the Informed Consent document</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Below 18 years of age</li>\n<li>Women who are pregnant</li>\n<li>Life expectancy of less than three months</li>\n</ul>\n</p>', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:52d0208a94ed93feaea61fa51f692e38' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:b6ad30c11341549c45416abb7b0cc6dc' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The purpose of this study is to determine if IMC-1121B given as monotherapy is effective in the treatment of Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma.</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:b6ad30c11341549c45416abb7b0cc6dc' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:750b953014a6fc2573638a77d1c11cbc' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This pilot study will help us to determine the success of using a special technique called microarray technology to examine cancer genes in order to predict how individual women will respond to one of two therapies, liposomal doxorubicin or topotecan, and which will be more effective in treating ovarian cancer that has returned (recurrent ovarian cancer). We believe that this study may lead to a means by which microarray technology can predict the most effective treatment decision, based on the genetic characteristics of her tumor tissue, for a woman with recurrent ovarian cancer. Another purpose of this study is to determine how quickly a woman with recurrent ovarian cancer will respond to treatment (treatment response rate) and to evaluate the accuracy of the genomic predictions. Recent data suggest that microarray technology can predict a patient\'s response to chemotherapy; this has not yet been proven in a forward-looking study which is why we are conducting this research.</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:750b953014a6fc2573638a77d1c11cbc' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:e40c02e4107f934b9f8c3e8fe2c0dae3' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>RATIONALE: A healthy lifestyle and counseling after treatment may improve progression-free survival in patients with previously treated cancer. PURPOSE: This randomized phase III trial is studying diet and physical activity changes to see how well they work compared with usual care in improving progression-free survival in patients with previously treated stage III or stage IV ovarian epithelial cancer or primary peritoneal cancer.</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:e40c02e4107f934b9f8c3e8fe2c0dae3' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:c4b22b7379944f649116d90f0045c550' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Quality of life and physical function [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:c4b22b7379944f649116d90f0045c550' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:663c1b8e0cf2efa2aeae720ab1146092' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Blood markers in predicting progression or death [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:663c1b8e0cf2efa2aeae720ab1146092' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:d0a24294849dd40bfd85b821c0781672' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Blood markers in predicting recurrence or survival [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:d0a24294849dd40bfd85b821c0781672' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:3cf511f3a5f24643f9ff96f58ebe5ea8' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Plasma carotenoid levels [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:3cf511f3a5f24643f9ff96f58ebe5ea8' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:a3c2f08066996282fa4b6717e73d5dd0' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Patient compliance [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:a3c2f08066996282fa4b6717e73d5dd0' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:67b41a60dd55abdf931b60880fb36723' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Impact on other aspects of quality of life [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:67b41a60dd55abdf931b60880fb36723' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:89907e21e240711d23ad4be6f446f4a8' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Impact on bowel function [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:89907e21e240711d23ad4be6f446f4a8' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:aacaf76024ee20677936184433c1ffeb' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>RATIONALE: Sodium thiosulfate may reduce or prevent hearing loss in young patients receiving cisplatin for cancer. It is not yet known whether sodium thiosulfate is more effective than no additional treatment in preventing hearing loss. PURPOSE: This randomized phase III trial is studying sodium thiosulfate to see how well it works compared with no additional treatment in preventing hearing loss in young patients receiving cisplatin for newly diagnosed germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, or osteosarcoma.</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:aacaf76024ee20677936184433c1ffeb' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:265105321875dcf0139d99431c789d78' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>A Randomized Phase III Study of Sodium Thiosulfate for the Prevention of Cisplatin-Induced Ototoxicity in Children</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:265105321875dcf0139d99431c789d78' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:b398d3dbad0909673f022c76b018e5a0' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>OBJECTIVES: Primary\n<ul>\n<li>To compare the efficacy of sodium thiosulfate vs observation in preventing hearing loss in young patients receiving cisplatin for the treatment of newly diagnosed germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, or osteosarcoma.</li>\n</ul>\n</p><p> Secondary\n<ul>\n<li>To compare the mean change in hearing thresholds for key frequencies in these patients.</li>\n<li>To compare the incidences of cisplatin-related grade 3 and 4 nephrotoxicity and grade 3 and 4 cytopenia in these patients.</li>\n<li>To compare the event-free survival and overall survival of these patients.</li>\n</ul>\n</p><p> OUTLINE: This is a multicenter study. Patients are stratified according to age (&lt; 5 years vs &#8805; 5 years) and duration of cisplatin infusion (&lt; 2 hours vs &#8805; 2 hours). Patients are randomized to 1 of 2 arms.\n<ul>\n<li>Arm I (sodium thiosulfate): Patients receive sodium thiosulfate IV over 15 minutes beginning 6 hours after the completion of each cisplatin infusion.</li>\n</ul>\n</p><p> Treatment with sodium thiosulfate continues until the completion of cisplatin therapy.\n<ul>\n<li>Arm II (observation): Patients do not receive sodium thiosulfate. Patients undergo audiological assessment at baseline, prior to each course of cisplatin, and then at 4 weeks and 1 year after the last course of cisplatin or other cancer treatment.</li>\n</ul>\n</p><p> After completion of study, patients are followed periodically for 10 years.</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:b398d3dbad0909673f022c76b018e5a0' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:73c749e4d5acdf66f0b8c68dfe9ac7a4' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>DISEASE CHARACTERISTICS:\n<ul>\n<li>Histologically confirmed germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, or osteosarcoma</li>\n<li>Newly diagnosed disease (previously untreated or currently receiving cancer treatment for the diagnosis that made the patient eligible for this study)</li>\n<li>Planning to receive a chemotherapy treatment regimen that includes a cumulative cisplatin dose &#8805; 200 mg/m&#178; with individual cisplatin doses to be infused over &#8804; 6 hours</li>\n<li>Enrolled on hearing assessment clinical trial COG-ACCL05C1\n<ul>\n<li>Normal auditory results</li>\n</ul>\n</li>\n</ul>\n</p><p> PATIENT CHARACTERISTICS:\n<ul>\n<li>Karnofsky performance status (PS) 50-100% (for patients &gt; 16 years of age)</li>\n<li>Lansky PS 50-100% (for patients &#8804; 16 years of age)</li>\n<li>Serum sodium normal</li>\n<li>Absolute granulocyte count &gt; 1,000/mm&#179;</li>\n<li>Platelet count &gt; 100,000/mm&#179;</li>\n<li>Creatinine clearance or radioisotope glomerular filtration rate &#8805; 70mL/min OR serum creatinine between 0.4 and 1.7 mg/dL, based on age and gender</li>\n<li>Total bilirubin &#8804; 1.5 times upper limit of normal (ULN) for age</li>\n<li>AST or ALT &lt; 2.5 times ULN for age</li>\n<li>Not pregnant or nursing</li>\n<li>Negative pregnancy test (if patient has child-bearing capacity)</li>\n<li>Fertile patients must use effective contraception</li>\n<li>No known hypersensitivity to sodium thiosulfate or other thiol agents (e.g., amifostine trihydrate, N-acetylcysteine, MESNA, or captopril)</li>\n</ul>\n</p><p> PRIOR CONCURRENT THERAPY:\n<ul>\n<li>See Disease Characteristics</li>\n<li>No prior platinum-based chemotherapy (cisplatin or carboplatin)\n<ul>\n<li>Other prior chemotherapy allowed</li>\n</ul>\n</li>\n<li>No prior radiotherapy that included the cochlea in the radiation field (whole brain, posterior fossa, or brain stem/pons region)</li>\n<li>At least 6 months since prior hematopoietic stem cell transplantation\n<ul>\n<li>No evidence of graft-versus-host disease</li>\n</ul>\n</li>\n<li>No concurrent enrollment on another COG clinical trial for treatment of the cancer\n<ul>\n<li>Concurrent enrollment on a non-COG clinical trial (e.g., Headstart) allowed</li>\n</ul>\n</li>\n<li>No concurrent cranial irradiation during the chemotherapy regimen (i.e., prior to the administration of the final dose of cisplatin)\n<ul>\n<li>Cranial irradiation after the completion of all systemic chemotherapy allowed provided post end-of-treatment audiometry is completed prior to beginning irradiation</li>\n</ul>\n</li>\n<li>Concurrent radiotherapy to extracranial sites allowed</li>\n</ul>\n</p>', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:73c749e4d5acdf66f0b8c68dfe9ac7a4' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:a9cf1b60cee59581ac836c2a5fd32de1' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Overall survival [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:a9cf1b60cee59581ac836c2a5fd32de1' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:dcaa1928b0b095aa18041c8dd4190fe7' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Mean change in hearing thresholds for key frequencies [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:dcaa1928b0b095aa18041c8dd4190fe7' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:9a088597c83ae5028c8d2c5f087857b5' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Incidences of cisplatin-related grade 3 and 4 nephrotoxicity and grade 3 and 4 cytopenia [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:9a088597c83ae5028c8d2c5f087857b5' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:7aa6888965c01226c0e13033f4c4ee2e' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Event-free-survival [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:7aa6888965c01226c0e13033f4c4ee2e' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:2b14e9da4b5cc0ed6a01d73a2d3506ae' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>To assess the efficacy of systematic pelvic and para-aortic lymphadenectomy in patients with advanced ovarian cancer and intra-abdominal complete debulking. Secondary: progression-free survival, complications and quality of life; Exploratory: Role of number of resected lymph nodes for primary and secondary objectives</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:2b14e9da4b5cc0ed6a01d73a2d3506ae' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:98760f3ae7c9d3a451f0eea253b9ed02' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Randomized, Multicentre Trial for Lymphadenectomy In Ovarian Neoplasms</p>\n', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:98760f3ae7c9d3a451f0eea253b9ed02' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Primary diagnosis of invasive epithelial ovarian cancer FIGO stage IIB-IV (IV only if resectable metastasis in pleura, liver, spleen, and/or abdominal wall)</li>\n<li>Macroscopic complete resection</li>\n<li>Age: 18 - 75 years</li>\n<li>Patients who have given their signed and written informed consent</li>\n<li>Good performance status (ECOG 0/1)</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Non epithelial ovarian malignancies and borderline tumors</li>\n<li>Intraoperative clinically suspicious lymph nodes (bulky nodes)</li>\n<li>Secondary invasive neoplasms in the last 5 years (except synchronal endometrial carcinoma FIGO IA G1/2, non melanoma skin cancer, breast cancer T1 N0 M0 G1/2) or with any signs of relapse or activity.</li>\n<li>Recurrent ovarian cancer</li>\n<li>Prior chemotherapy for ovarian cancer or abdominal/pelvic radiotherapy</li>\n<li>Diseases of the lymph system (including lymph edema of unknown origin)</li>\n<li>Clinical relevant dysfunctions of blood clotting (including medicamentous conditioned reasons, e.g. ASS, if not stopped at least 7 days prior to surgery)</li>\n<li>Any significant medical reasons, age or performance status that will not allow to perform the study procedures (estimation of investigator)</li>\n<li>Prior retroperitoneal lymph node dissection (systematic or sampling)</li>\n<li>Pregnancy</li>\n<li>Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent</li>\n<li>Any reasons interfering with regular follow-up</li>\n</ul>\n</p>', created = 1283570808, expire = 1283657208, headers = '', serialized = 0 WHERE cid = '1:c17f9deb1ef31d848bc497a59adb22c3' in /persistent/html/includes/cache.inc on line 109.
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Palifermin in Preventing Oral Mucositis Caused by Chemotherapy and/or Radiation Therapy in Young Patients Undergoing Stem Cell Transplant

Trial phase: 
Phase II
Recruitment status: 
Not yet recruiting

RATIONALE: Palifermin may help relieve or prevent oral mucositis caused by chemotherapy and radiation therapy in young patients undergoing stem cell transplant. PURPOSE: This randomized phase II trial is studying palifermin to see how well it works compared with a placebo in preventing oral mucositis caused by chemotherapy and/or radiation therapy in young patients undergoing stem cell transplant.

Background information
Trial ID: 
NCT00728585
Other unique IDs: 
CDR0000588622
COG-ACCL0521
Official title: 

A Group-Wide Double-Blind Randomized Placebo-Controlled Trial of Palifermin to Prevent Chemotherapy and/or Radiotherapy Induced Oral Mucositis in Children Undergoing Autologous or Allogeneic Hematopoietic Stem Cell Transplantation

Detailed description: 

OBJECTIVES: Primary

  • To compare whether palifermin versus placebo administered to pediatric patients three days prior to conditioning and three days after autologous or allogeneic hematopoietic stem cell transplantation (HSCT) is associated with a reduction in the incidence of WHO grade 3 or 4 oral mucositis.

Number to be enrolled: 
200 patients

The Assessment of Preoperative Psychological Intervention on Stress in Women With Gynecological Malignancies

Trial phase: 
Phase III
Recruitment status: 
Recruiting

The purpose of this study is to asses the impact of a tailored preoperative psychological intervention on women with gynecological malignancies on psychological, physiological and immunological parameters

Background information
Trial ID: 
NCT00726635
Other unique IDs: 
0014-08-RMC
Official title: 

Assessment of the Impact of Preoperative Stress Reduction on Psychological, Physiological and Immunological Parameters in Women With Gynecological Malignancies - Prospective Randomized Controlled Trial

Detailed description: 

Surgery is considered one of the most stressful events in human life. Research indicates that patients show high levels of stress from at least six days before surgery and up to a week post the operation. Stress levels return to normalcy only after several weeks. Research shows that psychological interventions given to women suffering from cancer can improve their coping abilities and overall function, decreases stress levels, enhances adherence to treatments,and increases quality of life and even life expectancy.

Number to be enrolled: 
60 patients

Platinum Resistant Ovarian Cancer Evaluation of Doxil and EC145 Combination Therapy

Trial phase: 
Phase II
Recruitment status: 
Recruiting

The objective of this study is to compare progression-free survival (PFS) in subjects with platinum-resistant ovarian cancer who receive combination therapy with EC145 and pegylated liposomal doxorubicin (PLD/Doxil®/Caelyx®)versus PLD alone.

Background information
Trial ID: 
NCT00722592
Other unique IDs: 
EC-FV-04
Official title: 

A Randomized Phase II Trial Comparing EC145 and Pegylated Liposomal Doxorubicin (PLD/Doxil/Caelyx) in Combination, Versus PLD Alone, in Subjects With Platinum-Resistant Ovarian Cancer

Detailed description: 

This is a Phase II clinical trial to evaluate the efficacy and safety of the combination of EC145 and pegylated liposomal doxorubicin (PLD; available in the United States as Doxil® and outside the United States as Caelyx®) compared to PLD alone. EC145 is a drug that is specifically designed to enter cancer cells via the folate vitamin receptor (FR). Experimental evidence shows that this target receptor is expressed on virtually all ovarian cancers.

Number to be enrolled: 
122 patients
Acronym: 
PRECEDENT

Allogeneic Whole Cell Cancer Vaccine for Metastatic Epithelial Tumors

Trial phase: 
Phase I
Recruitment status: 
Not yet recruiting

This study is based on the finding that tumor cells that are grown in the laboratory can be modified in such a way that, when injected to the patient, they will stimulate his/her immune response. This approach will be evaluated in patients with colorectal, gastric, ovarian, breast or lung epithelial cancer. Tumor cells grown in the laboratory will be modified to make them stimulatory to the immune system, irradiated to kill them, and injected to the patient eight times at two-week intervals . This protocol is expected to prolong survival of metastatic epithelial cancer patients.

Background information
Trial ID: 
NCT00722228
Other unique IDs: 
0359-08-HMO-CTIL
Official title: 

 

Detailed description: 

 

Number to be enrolled: 
0 patients

Study of IMC-1121B in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma

The purpose of this study is to determine if IMC-1121B given as monotherapy is effective in the treatment of Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma.

Background information
Other unique IDs: 
CP12-0711

Genomic Directed Salvage Chemotherapy With Either Liposomal Doxorubicin Or Topotecan

This pilot study will help us to determine the success of using a special technique called microarray technology to examine cancer genes in order to predict how individual women will respond to one of two therapies, liposomal doxorubicin or topotecan, and which will be more effective in treating ovarian cancer that has returned (recurrent ovarian cancer). We believe that this study may lead to a means by which microarray technology can predict the most effective treatment decision, based on the genetic characteristics of her tumor tissue, for a woman with recurrent ovarian cancer. Another purpose of this study is to determine how quickly a woman with recurrent ovarian cancer will respond to treatment (treatment response rate) and to evaluate the accuracy of the genomic predictions. Recent data suggest that microarray technology can predict a patient's response to chemotherapy; this has not yet been proven in a forward-looking study which is why we are conducting this research.

Background information
Other unique IDs: 
MCC-15042
USFIRB#106178d
NFGC 12-12990-01-29

Diet and Physical Activity Change or Usual Care in Improving Survival in Patients With Previously Treated Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer

RATIONALE: A healthy lifestyle and counseling after treatment may improve progression-free survival in patients with previously treated cancer. PURPOSE: This randomized phase III trial is studying diet and physical activity changes to see how well they work compared with usual care in improving progression-free survival in patients with previously treated stage III or stage IV ovarian epithelial cancer or primary peritoneal cancer.

Background information
Other unique IDs: 
CDR0000594600
GOG-0225

Sodium Thiosulfate in Preventing Hearing Loss in Young Patients Receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, or Osteosarcoma

Trial phase: 
Phase III
Recruitment status: 
Recruiting

RATIONALE: Sodium thiosulfate may reduce or prevent hearing loss in young patients receiving cisplatin for cancer. It is not yet known whether sodium thiosulfate is more effective than no additional treatment in preventing hearing loss. PURPOSE: This randomized phase III trial is studying sodium thiosulfate to see how well it works compared with no additional treatment in preventing hearing loss in young patients receiving cisplatin for newly diagnosed germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, or osteosarcoma.

Background information
Trial ID: 
NCT00716976
Other unique IDs: 
CDR0000588655
COG-ACCL0431
Official title: 

A Randomized Phase III Study of Sodium Thiosulfate for the Prevention of Cisplatin-Induced Ototoxicity in Children

Detailed description: 

OBJECTIVES: Primary

  • To compare the efficacy of sodium thiosulfate vs observation in preventing hearing loss in young patients receiving cisplatin for the treatment of newly diagnosed germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, or osteosarcoma.

Number to be enrolled: 
120 patients

Lymphadenectomy In Ovarian Neoplasms

Recruitment status: 
Not yet recruiting

To assess the efficacy of systematic pelvic and para-aortic lymphadenectomy in patients with advanced ovarian cancer and intra-abdominal complete debulking. Secondary: progression-free survival, complications and quality of life; Exploratory: Role of number of resected lymph nodes for primary and secondary objectives

Background information
Trial ID: 
NCT00712218
Other unique IDs: 
AGO-OVAR OP.3
Official title: 

Randomized, Multicentre Trial for Lymphadenectomy In Ovarian Neoplasms

Detailed description: 

 

Number to be enrolled: 
0 patients
Acronym: 
LION

The Effect of TRA-8 on Ovarian Cancer Tissue

The goal of this study is to determine the apoptosis-inducing efficacy of TRA-8 in patient ovarian cancer tissues using a tissue slice technology. In addition, we want to evaluate the expression of apoptosis regulatory proteins using multiplex proteomic technology and its correlation with TRA-8-induced cytotoxicity in patient ovarian cancer tissues.

Background information
Other unique IDs: 
F080328006/UAB0802
ROI CA 123197-01
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