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Docetaxel in Treating Women With Ovarian Epithelial or Primary Peritoneal Cancer Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Docetaxel in Treating Women With Ovarian Epithelial or Primary Peritoneal Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Docetaxel in Treating Women With Ovarian Epithelial or Primary Peritoneal Cancer Clinical research trials and Docetaxel in Treating Women With Ovarian Epithelial or Primary Peritoneal Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Docetaxel in Treating Women With Ovarian Epithelial or Primary Peritoneal Cancer. Docetaxel in Treating Women With Ovarian Epithelial or Primary Peritoneal Cancer Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Docetaxel in Treating Women With Ovarian Epithelial or Primary Peritoneal Cancer clinical trial. Subjects often receive the most expert healthcare possible for their Docetaxel in Treating Women With Ovarian Epithelial or Primary Peritoneal Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Docetaxel in Treating Women With Ovarian Epithelial or Primary Peritoneal Cancer Docetaxel in Treating Women With Ovarian Epithelial or Primary Peritoneal Cancer
Docetaxel in Treating Women With Ovarian Epithelial or Primary Peritoneal Cancer
For Condition: peritoneal cavity cancer,recurrent ovarian epithelial cancer
Status: No longer recruiting
Sponsor(s): Beth Israel Deaconess Medical Center ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating women who have ovarian epithelial cancer or primary peritoneal cancer that has not responded to previous treatment.
Details: OBJECTIVES: - Determine the activity of docetaxel in women with platinum resistant, refractory ovarian epithelial or primary peritoneal serous cancer. OUTLINE: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive a minimum of 6 courses of therapy, including 2 courses beyond CR. PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed ovarian epithelial or primary peritoneal serous cancer that is resistant to platinum therapy - Platinum resistance as defined by one of the following: - Relapse within 6 months of platinum based chemotherapy - Residual disease after completion of platinum based chemotherapy - Disease progression while receiving platinum based chemotherapy - Marker only relapse (CA-125 elevation) and measurable disease - Bidimensionally measurable disease on exam or CT scan PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Female Performance status: - ECOG 0-2 Life expectancy: - Greater than 2 months Hematopoietic: - WBC at least 3,000/mm3 - Absolute neutrophil count at least 1,500/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin no greater than upper limit of normal (ULN) - SGPT or SGOT no greater than 1.5 times ULN - Alkaline phosphatase no greater than 2.5 times ULN Renal: - Creatinine no greater than 1.5 mg/dL Cardiovascular: - Acceptable cardiac exam - No active cardiac ischemia Pulmonary: - Acceptable pulmonary exam - No active pulmonary infection or compromise Other: - Not pregnant or nursing - No severe peripheral neuropathy (grade 2 or greater) - No other significant psychiatric or medical conditions that would interfere with compliance - No other malignancies within the past 3 years, except: - Limited basal or squamous cell skin cancer - Carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior cytokine therapy Chemotherapy: - See Disease Characteristics - At least 3 weeks since prior chemotherapy for ovarian epithelial or peritoneal serous cancer - Prior paclitaxel allowed - No prior docetaxel - At least 3 years since prior chemotherapy for other disease Endocrine therapy: - Not specified Radiotherapy: - No prior pelvic radiotherapy Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StephenCannistra, Study Chair, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Additional Information:
Study ID Numbers: CDR0000067292; BIH-99-1286,NCI-V99-1565
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004081
Other Peritoneal Cavity Cancer Studies:
1. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Persistent Epithelial Ovarian Cancer, Fallopian Tube, or Primary Peritoneal Cancer
2. Docetaxel in Treating Women With Ovarian Epithelial or Primary Peritoneal Cancer
3. UCN-01 and Topotecan in Treating Patients With Recurrent, Persistent, or Progressive Advanced Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
4. Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer
5. Imatinib Mesylate in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer
Related Studies:
Other peritoneal cavity cancer Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Docetaxel in Treating Women With Ovarian Epithelial or Primary Peritoneal Cancer
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