Ovarian Cancer

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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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