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BMS-247550 in Treating Patients With Relapsed and/or Refractory Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on BMS-247550 in Treating Patients With Relapsed and/or Refractory Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. BMS-247550 in Treating Patients With Relapsed and/or Refractory Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer Clinical research trials and BMS-247550 in Treating Patients With Relapsed and/or Refractory Stage III or Stage IV 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 measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like BMS-247550 in Treating Patients With Relapsed and/or Refractory Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer. BMS-247550 in Treating Patients With Relapsed and/or Refractory Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a BMS-247550 in Treating Patients With Relapsed and/or Refractory Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer clinical trial. Subjects typically recieve the finest healthcare available for their BMS-247550 in Treating Patients With Relapsed and/or Refractory Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "B" Clinical Trials Conditions > BMS-247550 in Treating Patients With Relapsed and/or Refractory Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer  BMS-247550 in Treating Patients With Relapsed and/or Refractory Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer
BMS-247550 in Treating Patients With Relapsed and/or Refractory Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer
For Condition: peritoneal cavity cancer,stage 4 ovarian epithelial cancer,recurrent ovarian epithelial cancer,stage 3 ovarian epithelial cancer
Status: Not yet recruiting
Sponsor(s): Albert Einstein Cancer Research Center , National Cancer Institute (NCI)
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 BMS-247550 in treating patients who have relapsed and/or refractorystage III or stage IVovarian epithelial cancer or primaryperitoneal cancer.
Details: OBJECTIVES: - Determine the antitumor activity of BMS-247550, in terms of clinical response and progression-free survival, in patients with relapsed and/or refractory stage III or IV ovarian epithelial or primary peritoneal cancer. - Determine the nature and degree of toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive BMS-247550 IV over 1 hour once weekly on weeks 1-3. Treatment repeats every 4 weeks for a total of 3 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed stage III or IV ovarian epithelial cancer or primary peritoneal carcinoma - Recurrent or refractory disease - Previously treated with 1, and only 1, prior chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound and paclitaxel or docetaxel - Initial treatment may include high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment - Bidimensionally measurable disease by physical exam, CT scan, or MRI - Ascites and pleural effusions are not measurable disease - No prior irradiation to indicator lesions PATIENT CHARACTERISTICS: Age - 18 to 75 Performance status - GOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - No prior bleeding disorder or unexplained bleeding Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - SGOT/SGPT no greater than 2.5 times ULN - Alkaline phosphatase no greater than 2.5 times ULN Renal - Creatinine no greater than 1.5 times ULN Other - No active infection requiring antibiotics - No grade 2 or greater neuropathy (sensory and motor) - No other malignancy within the past 5 years except nonmelanoma skin cancer - No prior recurrent grade 2 or greater hypersensitivity reactions to Cremophor EL, docetaxel, or paclitaxel - No other medical condition that would preclude study participation - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - At least 3 weeks since prior biologic or immunologic therapy for ovarian epithelial or primary peritoneal carcinoma Chemotherapy - See Disease Characteristics - At least 3 weeks since prior chemotherapy and recovered - No prior BMS-247550 - No prior cytotoxic chemotherapy (including retreatment with initial chemotherapy regimens) for recurrent or persistent ovarian epithelial or primary peritoneal carcinoma Endocrine therapy - At least 1 week since prior hormonal therapy for ovarian epithelial or primary peritoneal carcinoma - Concurrent hormonal replacement therapy allowed Radiotherapy - See Disease Characteristics - At least 3 weeks since prior radiotherapy and recovered - No prior radiotherapy to a site of measurable disease used on study - No prior radiotherapy to more than 25% of bone marrow Surgery - See Disease Characteristics - Recovered from prior surgery Other - At least 3 weeks since other prior therapies for ovarian epithelial or primary peritoneal carcinoma - No prior cancer treatment for other invasive malignancies that would preclude study participation - No concurrent heparin or other anticoagulants - No concurrent St. John's Wort or any product containing this compound
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GaryGoldberg, Study Chair, Albert Einstein Cancer Research Center
Additional Information:
Study ID Numbers: CDR0000069190; NCI-3632,AECM-3632,MCC-12602
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030706
Other Stage 3 Ovarian Epithelial Cancer Studies:
1. Monoclonal Antibody Vaccine Therapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
2. UCN-01 and Topotecan in Treating Patients With Recurrent, Persistent, or Progressive Advanced Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
3. Amifostine in Treating Patients With Ovarian Epithelial Cancer Who Are Receiving Chemotherapy
4. Paclitaxel and Carboplatin With or Without Epirubicin in Treating Patients With Stage IIB, Stage III, or Stage IV Invasive Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
5. Lurtotecan Liposome in Treating Patients With Advanced or Recurrent Ovarian Epithelial Cancer
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BMS-247550 in Treating Patients With Relapsed and/or Refractory Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer
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