National Comprehensive Cancer Network

  • 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:d671c83d5d09cce284b6cd4179fb96ea' 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: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation given together with carboplatin works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.</p>\n', created = 1283939504, expire = 1284025904, headers = '', serialized = 0 WHERE cid = '1:d671c83d5d09cce284b6cd4179fb96ea' 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>Phase II Trial of Abraxane Plus Carboplatin for Advanced NSCLC for Patients at Risk of Bleeding From VEGF Directed Therapies</p>\n', created = 1283939504, expire = 1284025904, headers = '', serialized = 0 WHERE cid = '1:689ff1ed51caa410865bfbe05cb6f039' 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 determine the response rate, in terms of overall response rate (complete response and partial response), of paclitaxel albumin-stabilized nanoparticle formulation and carboplatin in patients with stage IIIB-IV or recurrent non-small cell lung cancer who are ineligible for treatment with bevacizumab.</li>\n</ul>\n</p><p> Secondary\n<ul>\n<li>To evaluate safety of this regimen in these patients.</li>\n<li>To describe the overall survival of these patients.</li>\n<li>To describe progression-free survival of these patients.</li>\n</ul>\n</p><p> Tertiary Objectives\n<ul>\n<li>To explore, in a pilot fashion, the activity of this regimen using predictive biomarkers including serum SPARC levels, methylation of SPARC in primary tumor samples and serum, Ras mutations, ERCC1 and SPARC immunohistochemistry, and serum miRNA expression profiles.</li>\n</ul>\n</p><p> OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Paraffin-embedded tissue blocks or unstained slides and blood samples are collected for correlative studies. Samples are analyzed for serum SPARC by ELISA, Ras mutations, ERCC1 AND SPARC by immunohistochemistry, and serum miRNA expression profiling. After completion of study treatment, patients are followed periodically.</p>\n', created = 1283939504, expire = 1284025904, headers = '', serialized = 0 WHERE cid = '1:e2963d622ef251d4ea228ac6d1183018' 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>Histologically or cytologically confirmed advanced non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:\n<ul>\n<li>Stage IIIB disease with malignant pleural effusion</li>\n<li>Stage IV disease</li>\n<li>Recurrent disease</li>\n</ul>\n</li>\n<li>Squamous cell histology allowed</li>\n<li>Not eligible for curative treatment or treatment with bevacizumab</li>\n<li>Measurable disease according to RECIST</li>\n<li>Tumor (paraffin blocks or slides) must be available for correlative biomarker studies</li>\n<li>No uncontrolled brain metastases (or leptomeningeal disease)\n<ul>\n<li>Controlled brain metastases allowed\n<ul>\n<li>Able to receive appropriate therapeutic radiotherapy</li>\n<li>Able to taper off all steroids without symptoms suggestive of increased intracranial pressure (nausea, vomiting, focal neurologic symptoms) for at least 7 days</li>\n</ul>\n</li>\n</ul>\n</li>\n</ul>\n</p><p> PATIENT CHARACTERISTICS:\n<ul>\n<li>ECOG performance status 0-2</li>\n<li>ANC &#8805; 1.5 x 10^9/L</li>\n<li>Platelets &#8805; 100 x 10^9/L</li>\n<li>Hemoglobin &#8805; 9.0 g/L</li>\n<li>Total bilirubin &#8804; 1.5 mg/dL</li>\n<li>AST and ALT &lt; 2.5 times upper limit of normal</li>\n<li>Creatinine &#8804; 1.5 mg/dL OR creatinine clearance &gt; 50 mg/mL</li>\n<li>No known HIV or hepatitis B or C</li>\n<li>Not pregnant</li>\n<li>Negative pregnancy test</li>\n<li>Thrombotic or embolic event within the past 6 months allowed, provided adequately controlled with therapeutic anticoagulation</li>\n<li>Hemoptysis allowed, provided it is not life threatening or requires palliative procedures (e.g., endobronchial therapy or radiotherapy)</li>\n<li>No cardiac disease, including any of the following:\n<ul>\n<li>NYHA class III-IV congestive heart failure</li>\n<li>Unstable angina (angina symptoms at rest)</li>\n<li>New onset angina (began within the past 3 months)</li>\n<li>Myocardial infarction within the past 6 months</li>\n</ul>\n</li>\n<li>No uncontrolled hypertension, defined as systolic blood pressure (BP) &gt; 150 mm Hg or diastolic BP &gt; 90 mm Hg despite optimal medical management</li>\n<li>No peripheral neuropathy &#8805; grade 2</li>\n<li>No active clinically serious infection &gt; CTCAE grade 2</li>\n<li>No serious non-healing wound, ulcer, or bone fracture</li>\n<li>No significant traumatic injury within the past 4 weeks</li>\n<li>No evidence or history of bleeding diathesis or coagulopathy</li>\n<li>No prior malignancy, except for adequately treated basal cell skin cancer, carcinoma in situ of the cervix, or other cancer for which the patient has been disease-free for 2 years\n<ul>\n<li>Stage I (T1c) prostate cancer adequately treated 2 years prior to diagnosis of NSCLC allowed, however metastatic prostate cancer currently receiving hormonal therapy or chemotherapy is not allowed</li>\n</ul>\n</li>\n<li>No significant psychiatric illness, in the opinion of the principal investigator, that would prevent adequate informed consent or render therapy unsafe</li>\n</ul>\n</p><p> PRIOR CONCURRENT THERAPY:\n<ul>\n<li>See Disease Characteristics</li>\n<li>Concurrent therapeutic anticoagulation, &gt; 325 mg acetylsalicylic acid, or chronic non-steroid anti-inflammatory drug use allowed</li>\n<li>At least 14 days since prior and no concurrent radiotherapy</li>\n<li>More than 4 weeks since prior major surgery or open biopsy</li>\n</ul>\n</p>', created = 1283939504, expire = 1284025904, headers = '', serialized = 0 WHERE cid = '1:fa3e108138ade7faf010cefc121d7afb' 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>Overall survival [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283939504, expire = 1284025904, headers = '', serialized = 0 WHERE cid = '1:a9cf1b60cee59581ac836c2a5fd32de1' 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>Progression-free survival [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283939504, expire = 1284025904, headers = '', serialized = 0 WHERE cid = '1:0e79568ecdbbf006d075c1c708fed460' 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 exploratory clinical study is designed to obtain pre-therapeutic imaging assessments in 20 patients with metastatic renal cell cancer (RCC) and an early post therapy assessment at baseline and at various early time points (1 week in 5 patients, 2 weeks in 5 patients, 3 weeks in 5 patients and 4 weeks in 5 patients) after institution of standard approved sunitinib therapy at 37.5 mg/day. The clinical imaging biomarkers will include an assessment of tumor metabolism [Bannasch 1986, Frauwirth 2002, Garber 2006, Kelloff 2005, Pauwels 1998, Semenza 2001, Smith 1999, Smith 2000, Sokoloff 1977, Warburg 1956, Weber 1977A, Weber 1977B] (dynamic FDG-PET); tumor proliferation [Rasey 2002,Shields 2001, Shields 1998, Vesselle 2002, Schwartz 2003] (dynamic FLT-PET); tumor blood flow (H215O-PET, DCE MRI)[Lodge 2000], tumor perfusion (DCE-MRI)[Tofts 1999, Tofts 1997, Parker 1999]; and tumor blood volume (H215O-PET, DCE MRI)[Lodge 2000, Tofts 1999, Tofts 1997] in the same patient at baseline and then in the same patient at one of the post therapy time points (1 week, 2 weeks, 3 weeks or 4 weeks). We hypothesize that by using this set of imaging assessments it will be possible to determine an individual or more likely a set of imaging derived biomarkers that will accomplish several of the goals of the initiative which is providing funding for the study.</p>\n', created = 1283939504, expire = 1284025904, headers = '', serialized = 0 WHERE cid = '1:891fc4b14c3460286fa9a34fe9fada31' 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 find out what effects, good and/or bad, 2 doses of Cetuximab will have on head and neck cancer. The study is done because 250 mg/m2 given weekly does not work very well. Doses as high as 700 mg/m2 every other week appear to be no more toxic, so we will try to determine if 500 mg/m2 and 750 mg/m2 given every other week can work better. We do not know if it will help. We can use what we learn from this research study to help other people with the same disease.</p>\n', created = 1283939504, expire = 1284025904, headers = '', serialized = 0 WHERE cid = '1:562f536d4664ac5f0564359ac4425cf1' 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:f8a14b356c8a228a59e27351762feec6' 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 will compare the effects, good and/or bad of chemotherapy (Gemcitabine and Cisplatin) with or without the addition of the chemotherapy drug Cetuximab to find out which treatment is better.</p>\n', created = 1283939504, expire = 1284025904, headers = '', serialized = 0 WHERE cid = '1:f8a14b356c8a228a59e27351762feec6' 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>Phase II Randomized Trial fo Gemcitabine and Cisplatin With or Without Cetuximab in Patients With Urothelial Carcinoma</p>\n', created = 1283939504, expire = 1284025904, headers = '', serialized = 0 WHERE cid = '1:3c34d2ff4dd5321779c043926a7c6603' 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>Urothelial cancer typically begins in the lining of the bladder, the balloon-shaped organ in the pelvic area that stores urine. Urothelial cancer can also begin in the ureter (the tube connecting the kidney and bladder), part of the kidney itself, or the urethra (the tube you pass urine out of). Some Urothelial cancers remain confined to the lining, while in other cases they spread to other areas. Treatment for these cancers varies greatly depending on the stage of disease at the time of diagnosis. Study participants in this research study will have a diagnosis of urothelial cancer that is advanced or has come back after prior therapy. There are two standard chemotherapeutic regimens for the management of this disease. One is the combination of the drugs, methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC). However the toxicities associated with this treatment regimen (side effects) is high. The other is a combination of two drugs called Cisplatin and Gemcitabine. These drugs are also known to destroy urothelial cancer cells, and are better tolerated by patients. All study participants will receive both of these drugs. Another anti-cancer drug called Cetuximab is known to delay or prevent tumor growth and in some cases to lead to death of cancer cells by blocking certain cellular pathways that lead to tumor development. This drug has been approved by the United States Food and Drug Administration (FDA) for the treatment of colorectal cancer and for treatment of head and neck cancers. The use of Cetuximab for the treatment of urothelial cancer is investigational in this study. The purpose of this study is to compare the safety and efficacy of Gemcitabine and Cisplatin administered with or without the addition of Cetuximab in study participants with urothelial cancer. This is a randomized research study. Study participants will be randomized to receive either gemcitabine and cisplatin alone or in combination with Cetuximab.</p>\n', created = 1283939504, expire = 1284025904, headers = '', serialized = 0 WHERE cid = '1:65501136237324d951b974103f21e6c7' 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>Study participants will be male or female at least 18 years of age</li>\n<li>Study participants will have a histologic/cytologic diagnosis of urothelial carcinoma (transitional cell carcinoma; either pure or mixed histology) that is metastatic, locally recurrent, or unresectable (T4bN0 or any T, N2030)</li>\n<li>Study participants must have measurable disease by radiologic imaging. Study participants that have received previous radiation therapy, recovered from side effects and have not had more than 25% of the bone marrow</li>\n<li>Study participants must have adequate bone marrow function</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Study participants may not have received previous systemic chemotherapy for the current stage of disease with the following exception: prior neoadjuvant or adjuvant chemotherapy is allowed provided it has been at least 6 months since treatment with non-cisplatin containing regimens and &gt; 1 year since treatment with a cisplatin containing regimen </li>\n<li>Study participants may not have received prior therapy targeting the EGFR pathway</li>\n<li>Study participants may not have a history or known spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan</li>\n<li>Study participants may not have known HIV due to the intense nature of the chemotherapy in this trial</li>\n<li>Study subjects may not have a history of congestive heart failure (CHF), chronic renal failure, or prior grade 3 or 4 severe infusion reaction to monoclonal antibodies</li>\n<li>Study participants may not be pregnant or breastfeeding</li>\n<li>Study participants may not receive concurrent treatment on another therapeutic clinical trial.</li>\n</ul>\n</p>', created = 1283939504, expire = 1284025904, headers = '', serialized = 0 WHERE cid = '1:7b48bd100b84e0249f7576f208ec8ab5' 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 find out what effects gemcitabine plus capecitabine has on patients with pancreatic or biliary cancer, and to determine the optimal dose that can be given safely of these two drugs together (called the maximum tolerated dose). Gemcitabine and capecitabine are two chemotherapy drugs used to treat pancreatic and biliary cancer. These two drugs used together are considered an acceptable standard of care for pancreatic and biliary cancers. However, in this study the dose and dosing schedule will be changed, in the hopes that the drugs will have more effect with fewer side effects than when given in the standard way.</p>\n', created = 1283939504, expire = 1284025904, headers = '', serialized = 0 WHERE cid = '1:9e283904e70ab49e4cf31b2f35d6e5e8' 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 Phase I Study, With Expanded Cohort, of Biweekly Fixed-Dose Rate Gemcitabine Plus Capecitabine in Patients With Advanced Pancreatic and Biliary Carcinomas</p>\n', created = 1283939504, expire = 1284025904, headers = '', serialized = 0 WHERE cid = '1:818ddb9e4a7b19e3863bffdda28a2d4e' 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>Histologically-confirmed pancreatic adenocarcinoma or biliary tract carcinoma (cholangiocarcinoma or gallbladder cancer)</li>\n<li>Disease must not be amenable to surgical resection. Patients with either locally advanced or metastatic disease are eligible</li>\n<li>No prior systemic therapy for their diagnosis</li>\n<li>ECOG performance score of 0-1</li>\n<li>Evidence of either or both of the following:\n<ol>\n<li>RECIST-defined measurable disease (lesions that can be accurately measured in at least one dimension with the longest diameter &#8805; 20mm using conventional techniques or &#8805;10 mm with spiral CT scan)</li>\n<li>An elevated serum CA19-9 at baseline ( &#8805; 2X ULN)</li>\n</ol>\n</li>\n<li>Female patients must be either surgically sterile or postmenopausal, or if of childbearing potential must have a negative pregnancy test (serum or urine) prior to enrollment and agree to use effective barrier contraception during the period of therapy. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the investigator.</li>\n<li>Adequate bone marrow function:\n<ol>\n<li>ANC &#8805; 1500/uL</li>\n<li>platelet count &#8805; 100,000/uL</li>\n<li>hemoglobin &#8805; 9.0 g/dL</li>\n</ol>\n</li>\n<li>Adequate hepatic function:\n<ol>\n<li>Total bilirubin &#8804; 1.5 X ULN</li>\n<li>AST (SGOT) &#8804; 2.5 X ULN</li>\n<li>ALT (SGPT) &#8804; 2.5 X ULN</li>\n</ol>\n</li>\n<li>Adequate renal function as determined by either:\n<ol>\n<li>Calculated or measured creatinine clearance &#8805; 40 mL/min (for calculated creatinine clearance, Cockroft-Gault equation will be used)</li>\n<li>Serum creatinine &#8804; 1.5 X ULN</li>\n</ol>\n</li>\n<li>Ability to swallow oral medications</li>\n<li>Ability to understand the nature of this study protocol and give written informed consent</li>\n<li>Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Any prior systemic or investigational therapy for metastatic or locally advanced pancreatic cancer or biliary cancer. Systemic therapy administered alone or in combination with radiation in the adjuvant setting is permissible as long as it was completed &gt; 6 months prior to the time of study enrollment.</li>\n<li>Inability to comply with study and/or follow-up procedures.</li>\n<li>History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that, in the opinion of the investigator, renders the subject at high risk from treatment complications or might affect the interpretation of the results of the study.</li>\n<li>Presence of central nervous system or brain metastases.</li>\n<li>Pregnancy (positive pregnancy test) or lactation.</li>\n<li>Prior malignancy except for adequately treated basal cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other form of cancer from which the patient has been disease-free for 5 years.</li>\n<li>Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.</li>\n<li>Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.</li>\n<li>Known, existing uncontrolled coagulopathy.</li>\n<li>Major surgery within 4 weeks of the start of study treatment, without complete recovery.</li>\n<li>Concurrent/pre-existing use of coumadin.</li>\n</ul>\n</p>', created = 1283939504, expire = 1284025904, headers = '', serialized = 0 WHERE cid = '1:1e2eadcc8d7431ae3b137ad1b07a84c4' 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>overall survival [&nbsp;Time&nbsp;Frame:&nbsp;2 years&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283939504, expire = 1284025904, headers = '', serialized = 0 WHERE cid = '1:fc23b0a02b10af320e800862bf70dbfa' 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>Objective response rate (ORR) and disease control rate (DCR) in patients with measurable disease at baseline [&nbsp;Time&nbsp;Frame:&nbsp;2 years&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283939504, expire = 1284025904, headers = '', serialized = 0 WHERE cid = '1:4d2c588fd7b67e5fe4f1b4435d3f6975' 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>Biomarker (CA19-9) response rate (decline by &#8805; 50%) in patients with elevated CA19-9 (&#8805; 2x ULN) at baseline. [&nbsp;Time&nbsp;Frame:&nbsp;2 years&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283939504, expire = 1284025904, headers = '', serialized = 0 WHERE cid = '1:bbb27c104d5f24d4073263ce9166c058' 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>Time to tumor progression (TTP) [&nbsp;Time&nbsp;Frame:&nbsp;2 years&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283939504, expire = 1284025904, headers = '', serialized = 0 WHERE cid = '1:6d1ea742dc552123e221140d1229dfc8' 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>Frequency, type, and grade of adverse events using this combination in this patient population [&nbsp;Time&nbsp;Frame:&nbsp;2 years&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283939504, expire = 1284025904, headers = '', serialized = 0 WHERE cid = '1:d2f7cfcdceaec8538ce6b7db12d3ef18' 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:a9571f04be4be8fd3e77588afcdb1c5f' 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 aim of this research project is to determine the amount of capecitabine (Xeloda) which can be given safely with PHY906 (investigational drug) on a novel schedule. It is also the aim of this research project to determine what the effects, good and/or bad, are of combining capecitabine (Xeloda) with PHY906 (investigational drug) in the treatment of advanced pancreatic cancer. PHY906 is a powder from plants sold as a health food supplement in the United States. PHY906 has been used in China, Taiwan and other Asian countries as traditional Chinese medicine for hundreds of years. The other drug involved in this study, capecitabine is an oral form of chemotherapy already approved by FDA in the management of colorectal and breast cancer. Laboratory studies in animal models have shown that the combination of capecitabine and PHY906 shrinks liver cancer, and a pilot clinical study is currently evaluating this combination in patients with liver cancer to define the benefit. PHY906 has also shown to decrease diarrhea related to chemotherapy in a small study performed in patients with colon cancer treated at the Yale Cancer Center. Our recent laboratory studies have also shown that the combination of capecitabine and PHY906 also shrink pancreatic tumors in mouse models. This prompted us to test the combination of capecitabine and PHY906 in patients with advanced pancreatic cancer to assess the benefit in survival as well as any decrease in side effects, such as diarrhea caused by capecitabine.</p>\n', created = 1283939504, expire = 1284025904, headers = '', serialized = 0 WHERE cid = '1:a9571f04be4be8fd3e77588afcdb1c5f' 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 = '1:990a524e51a06b2bb1fed9d8a36d960e' 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>Primary Objectives:\n<ul>\n<li>To determine the feasibility, activity, and toxicity of a novel regimen using a concurrent irinotecan (CPT-11)/cisplatin and celecoxib combination for patients with unresectable NSCLC.</li>\n<li>To determine the maximal tolerance dose of celecoxib in patients with unresectable NSCLC treated with irinotecan/cisplatin and concurrent thoracic radiation therapy.</li>\n<li>To correlate the COX-2 expression and other biomarkers with response to the treatment in the tumor from a pretreatment biopsy specimen.</li>\n</ul>\n</p>', created = 1283939504, expire = 1284025904, headers = '', serialized = 0 WHERE cid = '1:990a524e51a06b2bb1fed9d8a36d960e' 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 = '1:556d193aeceb9ffcc76f912b59d45ca4' 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 study the side effects of this treatment. [&nbsp;Time&nbsp;Frame:&nbsp;February 2009&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283939504, expire = 1284025904, headers = '', serialized = 0 WHERE cid = '1:556d193aeceb9ffcc76f912b59d45ca4' 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 primary purpose of this study is to define the maximum tolerated dose of combination docetaxel, gemcitabine, and capecitabine in patients with pancreatic cancer. Adverse effects will be measured in study participants. In addition, researchers will assess data about preliminary efficacy in patients with this treatment approach.</p>\n', created = 1283939504, expire = 1284025904, headers = '', serialized = 0 WHERE cid = '1:ee69d43c0890cd2d7cbdc3fdd0d2e4ef' 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 Dose Escalating (Phase I) Study Looking at the Biomodulation of Capecitabine by Docetaxel and Gemcitabine in Patients With Advanced Pancreas Cancer</p>\n', created = 1283939504, expire = 1284025904, headers = '', serialized = 0 WHERE cid = '1:703f7286d6bcf6523e4630efa9033b83' 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:b4c3330d3db2071216f2f227fc08aab4' 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: Single agent gemcitabine is considered standard care for patients with advanced pancreatic cancer. However, better treatments offering improved outcomes are needed for people with this disease. The combination of docetaxel and capecitabine has shown significant and broad clinical activity in a variety of tumors. Laboratory research on the combination of capecitabine, docetaxel, and gemcitabine indicates synergistic action against tumor cells. The current study will test this combination in patients. The drug administration schedule in this study is aimed at maximizing the potential of activation of capecitabine by both docetaxel and gemcitabine. Treatment: Study participants will be given docetaxel, gemcitabine, and capecitabine. All study drugs will be administered through intravenous infusions in three week cycles. Docetaxel will be given on days 1 and 8, gemcitabine on days 8 and 15, and capecitabine on days 8 through 21. This schedule will be followed by 1 week of rest without administration of study drugs. Since the primary goal of this study is to identify the maximum tolerated dose of the study drugs in combination, patients who enroll in the beginning of the study will receive lower amounts of the study drugs compared to patients who enroll later in the study. Several tests and exams will be given throughout the study to closely monitor patients.</p>\n', created = 1283939504, expire = 1284025904, headers = '', serialized = 0 WHERE cid = '1:b4c3330d3db2071216f2f227fc08aab4' 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>adenocarcinoma of the pancreas</li>\n<li>no prior chemo except adjuvant</li>\n<li>ECOG PS 0-1</li>\n<li>peripheral neuropathy &lt;/= Gr. 1</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Pregnant/lactating females</li>\n<li>Uncontrolled heart disease, diabetes, psychiatric disorder</li>\n<li>Therapeutic doses of Warfarin</li>\n</ul>\n</p>', created = 1283939504, expire = 1284025904, headers = '', serialized = 0 WHERE cid = '1:2590bdfcb181f23b159bd8ac9269618c' 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>toxicity [&nbsp;Time&nbsp;Frame:&nbsp;weekly&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283939504, expire = 1284025904, headers = '', serialized = 0 WHERE cid = '1:9e235313977d0be19b1d663fa9045eac' 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>Therapeutic response [&nbsp;Time&nbsp;Frame:&nbsp;Prior to cycle 3 and then every 2 cycles thereafter&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283939504, expire = 1284025904, headers = '', serialized = 0 WHERE cid = '1:16d2deda311b09ece7eae542a802b7c0' in /persistent/html/includes/cache.inc on line 109.

Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

Trial phase: 
Phase II
Recruitment status: 
Recruiting

RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation given together with carboplatin works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.

Background information
Trial ID: 
NCT00729612
Other unique IDs: 
CDR0000602242
OSU-08059
NCCN-AO8
Official title: 

Phase II Trial of Abraxane Plus Carboplatin for Advanced NSCLC for Patients at Risk of Bleeding From VEGF Directed Therapies

Detailed description: 

OBJECTIVES: Primary

  • To determine the response rate, in terms of overall response rate (complete response and partial response), of paclitaxel albumin-stabilized nanoparticle formulation and carboplatin in patients with stage IIIB-IV or recurrent non-small cell lung cancer who are ineligible for treatment with bevacizumab.

Secondary

  • To evaluate safety of this regimen in these patients.
  • To describe the overall survival of these patients.
  • To describe progression-free survival of these patients.

Number to be enrolled: 
63 patients

Sunitinib for Metastatic Renal Cell Cancer With Imaging Biomarker Assessments for the Early Prediction of Tumor Response

This exploratory clinical study is designed to obtain pre-therapeutic imaging assessments in 20 patients with metastatic renal cell cancer (RCC) and an early post therapy assessment at baseline and at various early time points (1 week in 5 patients, 2 weeks in 5 patients, 3 weeks in 5 patients and 4 weeks in 5 patients) after institution of standard approved sunitinib therapy at 37.5 mg/day. The clinical imaging biomarkers will include an assessment of tumor metabolism [Bannasch 1986, Frauwirth 2002, Garber 2006, Kelloff 2005, Pauwels 1998, Semenza 2001, Smith 1999, Smith 2000, Sokoloff 1977, Warburg 1956, Weber 1977A, Weber 1977B] (dynamic FDG-PET); tumor proliferation [Rasey 2002,Shields 2001, Shields 1998, Vesselle 2002, Schwartz 2003] (dynamic FLT-PET); tumor blood flow (H215O-PET, DCE MRI)[Lodge 2000], tumor perfusion (DCE-MRI)[Tofts 1999, Tofts 1997, Parker 1999]; and tumor blood volume (H215O-PET, DCE MRI)[Lodge 2000, Tofts 1999, Tofts 1997] in the same patient at baseline and then in the same patient at one of the post therapy time points (1 week, 2 weeks, 3 weeks or 4 weeks). We hypothesize that by using this set of imaging assessments it will be possible to determine an individual or more likely a set of imaging derived biomarkers that will accomplish several of the goals of the initiative which is providing funding for the study.

Background information
Other unique IDs: 
HCI 21897

Cetuximab at Either 500 or 750 mg/m2 Every Other Week for Recurrent or Metastatic Head and Neck Squamous Cell Cancer

The purpose of this study is to find out what effects, good and/or bad, 2 doses of Cetuximab will have on head and neck cancer. The study is done because 250 mg/m2 given weekly does not work very well. Doses as high as 700 mg/m2 every other week appear to be no more toxic, so we will try to determine if 500 mg/m2 and 750 mg/m2 given every other week can work better. We do not know if it will help. We can use what we learn from this research study to help other people with the same disease.

Background information
Other unique IDs: 
08-039

Study of Gemcitabine and Cisplatin With or Without Cetuximab in Urothelial Cancer

Trial phase: 
Phase II
Recruitment status: 
Recruiting

This study will compare the effects, good and/or bad of chemotherapy (Gemcitabine and Cisplatin) with or without the addition of the chemotherapy drug Cetuximab to find out which treatment is better.

Background information
Trial ID: 
NCT00645593
Other unique IDs: 
UMCC 2007.097
Official title: 

Phase II Randomized Trial fo Gemcitabine and Cisplatin With or Without Cetuximab in Patients With Urothelial Carcinoma

Detailed description: 

Urothelial cancer typically begins in the lining of the bladder, the balloon-shaped organ in the pelvic area that stores urine. Urothelial cancer can also begin in the ureter (the tube connecting the kidney and bladder), part of the kidney itself, or the urethra (the tube you pass urine out of). Some Urothelial cancers remain confined to the lining, while in other cases they spread to other areas. Treatment for these cancers varies greatly depending on the stage of disease at the time of diagnosis.

Number to be enrolled: 
81 patients

Gemcitabine and Capecitabine to Treat Patients With Advanced Pancreatic and Biliary Cancers

Trial phase: 
Phase I
Recruitment status: 
Recruiting

The purpose of this study is to find out what effects gemcitabine plus capecitabine has on patients with pancreatic or biliary cancer, and to determine the optimal dose that can be given safely of these two drugs together (called the maximum tolerated dose). Gemcitabine and capecitabine are two chemotherapy drugs used to treat pancreatic and biliary cancer. These two drugs used together are considered an acceptable standard of care for pancreatic and biliary cancers. However, in this study the dose and dosing schedule will be changed, in the hopes that the drugs will have more effect with fewer side effects than when given in the standard way.

Background information
Trial ID: 
NCT00626158
Other unique IDs: 
CC#074510
Official title: 

A Phase I Study, With Expanded Cohort, of Biweekly Fixed-Dose Rate Gemcitabine Plus Capecitabine in Patients With Advanced Pancreatic and Biliary Carcinomas

Detailed description: 

 

Number to be enrolled: 
24 patients

A Phase I/II, Multi-Center, Open-Label, Dose-Escalation, Safety and Efficacy Study of PHY906 Plus Capecitabine in Patients With Advanced Pancreatic Carcinoma

The aim of this research project is to determine the amount of capecitabine (Xeloda) which can be given safely with PHY906 (investigational drug) on a novel schedule. It is also the aim of this research project to determine what the effects, good and/or bad, are of combining capecitabine (Xeloda) with PHY906 (investigational drug) in the treatment of advanced pancreatic cancer. PHY906 is a powder from plants sold as a health food supplement in the United States. PHY906 has been used in China, Taiwan and other Asian countries as traditional Chinese medicine for hundreds of years. The other drug involved in this study, capecitabine is an oral form of chemotherapy already approved by FDA in the management of colorectal and breast cancer. Laboratory studies in animal models have shown that the combination of capecitabine and PHY906 shrinks liver cancer, and a pilot clinical study is currently evaluating this combination in patients with liver cancer to define the benefit. PHY906 has also shown to decrease diarrhea related to chemotherapy in a small study performed in patients with colon cancer treated at the Yale Cancer Center. Our recent laboratory studies have also shown that the combination of capecitabine and PHY906 also shrink pancreatic tumors in mouse models. This prompted us to test the combination of capecitabine and PHY906 in patients with advanced pancreatic cancer to assess the benefit in survival as well as any decrease in side effects, such as diarrhea caused by capecitabine.

Background information
Other unique IDs: 
0512000905

CPT-11/Cisplatin and Celecoxib With Radiation Therapy for Patients With Unresectable Non-Small Cell Lung Cancer (NSCLC)

Primary Objectives:

  • To determine the feasibility, activity, and toxicity of a novel regimen using a concurrent irinotecan (CPT-11)/cisplatin and celecoxib combination for patients with unresectable NSCLC.
  • To determine the maximal tolerance dose of celecoxib in patients with unresectable NSCLC treated with irinotecan/cisplatin and concurrent thoracic radiation therapy.
  • To correlate the COX-2 expression and other biomarkers with response to the treatment in the tumor from a pretreatment biopsy specimen.

Background information
Other unique IDs: 
2003-0352

Capecitabine, Docetaxel and Gemcitabine in Patients With Advanced Pancreas Cancer

Trial phase: 
Phase I
Recruitment status: 
Recruiting

The primary purpose of this study is to define the maximum tolerated dose of combination docetaxel, gemcitabine, and capecitabine in patients with pancreatic cancer. Adverse effects will be measured in study participants. In addition, researchers will assess data about preliminary efficacy in patients with this treatment approach.

Background information
Trial ID: 
NCT00320749
Other unique IDs: 
OSU-05058
Official title: 

A Dose Escalating (Phase I) Study Looking at the Biomodulation of Capecitabine by Docetaxel and Gemcitabine in Patients With Advanced Pancreas Cancer

Detailed description: 

Rationale: Single agent gemcitabine is considered standard care for patients with advanced pancreatic cancer. However, better treatments offering improved outcomes are needed for people with this disease. The combination of docetaxel and capecitabine has shown significant and broad clinical activity in a variety of tumors. Laboratory research on the combination of capecitabine, docetaxel, and gemcitabine indicates synergistic action against tumor cells. The current study will test this combination in patients.

Number to be enrolled: 
24 patients
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