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BMS-247550 in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer That Has Not Responded to Previous Chemotherapy Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on BMS-247550 in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer That Has Not Responded to Previous Chemotherapy conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. BMS-247550 in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer That Has Not Responded to Previous Chemotherapy Clinical research trials and BMS-247550 in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer That Has Not Responded to Previous Chemotherapy healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including BMS-247550 in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer That Has Not Responded to Previous Chemotherapy. BMS-247550 in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer That Has Not Responded to Previous Chemotherapy Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a BMS-247550 in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer That Has Not Responded to Previous Chemotherapy clinical trial. Test subjects typically receive the most effective healthcare possible for their BMS-247550 in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer That Has Not Responded to Previous Chemotherapy condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "B" Clinical Trials Conditions > BMS-247550 in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer That Has Not Responded to Previous Chemotherapy  BMS-247550 in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer That Has Not Responded to Previous Chemotherapy
BMS-247550 in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer That Has Not Responded to Previous Chemotherapy
For Condition: recurrent ovarian epithelial cancer,peritoneal cavity cancer
Status: Suspended
Sponsor(s): Gynecologic Oncology Group , 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 recurrent or persistent ovarian epithelial or primary peritoneal cancer that has not responded to previous chemotherapy.
Details: OBJECTIVES: - Determine the antitumor activity of BMS-247550 in patients with recurrent or persistent platinum and paclitaxel-refractory ovarian epithelial or primary peritoneal cancer. - Determine the nature and degree of toxicity of this drug in these patients. OUTLINE: Patients receive BMS-247550 IV over 1 hour. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 6-12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed ovarian epithelial cancer or primary peritoneal cancer - Recurrent or persistent disease - Platinum AND taxane-resistant or refractory disease - Progressed during therapy OR - Refractory disease within 6 months of therapy - Measurable disease - At least 20 mm by conventional techniques - At least 10 mm by spiral CT scan - Ineligible for higher priority GOG protocol - No active brain metastases PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - GOG 0-2 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm3 - Platelet count at least lower limit of normal Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - SGOT 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 Neurologic: - No sensory or motor neuropathy greater than grade 1 - No dementia or altered mental status Other: - No other serious uncontrolled medical disorder - No active infection requiring antibiotics - No prior hypersensitivity reaction to paclitaxel or other therapy containing Cremophor EL - No other malignancy within the past 5 years except nonmelanoma skin cancer - 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 therapy - At least 3 weeks since prior immunotherapy Chemotherapy: - See Disease Characteristics - Must have received: - 1 prior combination taxane-based and platinum-based chemotherapy regimen OR - 1 prior platinum-based chemotherapy regimen AND 1 prior taxane-based chemotherapy regimen - Initial treatment may include high-dose therapy, consolidation, or extended therapy - At least 3 weeks since prior chemotherapy and recovered - No prior BMS-247550 - No other prior cytotoxic chemotherapy for recurrent or persistent disease, including treatment with initial regimen Endocrine therapy: - At least 1 week since prior hormonal anticancer therapy - Concurrent hormone replacement therapy allowed Radiotherapy: - At least 3 weeks since prior radiotherapy and recovered - No prior radiotherapy to site(s) of measurable disease - No radiotherapy to more than 25% of marrow-containing areas Surgery: - Recovered from recent surgery Other: - At least 3 weeks since other anticancer therapy - No prior anticancer therapy that precludes study - No concurrent food supplements (e.g., St. John's Wort) - No concurrent amifostine or other protective agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidSpriggs, Study Chair, Memorial Sloan-Kettering Cancer Center
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
United States
Cooper University Hospital
Camden, New Jersey, 08103-1489
United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11794-8091
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190
United States
Norwegian Radium Hospital
Oslo, , N-0310
Norway
MBCCOP - Hawaii
Honolulu, Hawaii, 96813
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Tufts - New England Medical Center
Boston, Massachusetts, 02111
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001-3788
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1740
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0587
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
United States
Ireland Cancer Center
Cleveland, Ohio, 44106
United States
Barrett Cancer Center
Cincinnati, Ohio, 45267-0526
United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, 80010
United States
Additional Information:
Study ID Numbers: CDR0000068927; GOG-0126M
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025155
Other Recurrent Ovarian Epithelial Cancer Studies:
1. Bortezomib and Carboplatin in Treating Patients With Recurrent or Progressive Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
2. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III Ovarian Cancer
3. Radiolabeled Monoclonal Antibody, Paclitaxel, and Interferon alfa in Treating Patients With Recurrent Ovarian Cancer
4. Fluorouracil With or Without Mitomycin in Treating Patients With Peritoneal Cancer
5. Combination Chemotherapy in Treating Women With Stage III Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Related Studies:
Other recurrent ovarian epithelial cancer Clinical Trials
Other New Jersey Clinical Trials
Other Camden Clinical Trials
BMS-247550 in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer That Has Not Responded to Previous Chemotherapy
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