Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum
This trial is active, not recruiting.
|Conditions||fallopian tube cancer, ovarian cancer, primary peritoneal cavity cancer|
|Start date||September 1997|
|Trial size||100 participants|
|Trial identifier||NCT00003160, BMS-TAX/MEN.03, CDR0000065955, NCI-V97-1366, THERADEX-B97-3250|
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different ways may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating women with stage III or stage IV ovarian cancer that is refractory to paclitaxel and platinum-based regimens.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Mobile, AL||Oncology Center at Providence Park||no longer recruiting|
|Phoenix, AZ||Hematology Associates, Ltd.||no longer recruiting|
|Fayetteville, AR||Highlands Oncology Group, P.A.||no longer recruiting|
|Santa Barbara, CA||Cancer Center of Santa Barbara||no longer recruiting|
|West Palm Beach, FL||Good Samaritan Medical Center||no longer recruiting|
|Decatur, IL||Decatur Memorial Hospital Cancer Care Institute||no longer recruiting|
|Omaha, NE||Creighton University Cancer Center||no longer recruiting|
|Neptune, NJ||Jersey Shore Cancer Center||no longer recruiting|
|Albany, NY||Women's Health Center at Albany Medical Center||no longer recruiting|
|Charlotte, NC||Carolinas Medical Center||no longer recruiting|
|Akron, OH||Akron General Medical Center||no longer recruiting|
|Cincinnati, OH||Oncology/Hematology Care, Inc.||no longer recruiting|
|Cleveland, OH||Cleveland Clinic Cancer Center||no longer recruiting|
|Harrisburg, PA||Women's Cancer Center of Central PA, P.C.||no longer recruiting|
|Providence, RI||Women and Infants Hospital of Rhode Island||no longer recruiting|
|Nashville, TN||Brookview Research, Inc.||no longer recruiting|
|Amarillo, TX||Harrington Cancer Center||no longer recruiting|
|Spokane, WA||Rockwood Clinic P.S.||no longer recruiting|
Female participants at least 18 years old.
DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV ovarian cancer that is refractory to an initial chemotherapy regimen that included a platinum agent plus paclitaxel - Epithelial ovarian cancer - Primary carcinoma of the peritoneum - Fallopian tube cancer Initial response to platinum and paclitaxel must have been one of the following: Progression or stable disease Response that lasted less than 3 months Response that lasted at least 3 months, but when retreated with both agents (in combination or as single agents) disease was refractory Measurable or evaluable disease Evaluable disease is defined by: CA-125 at least 100 units/mL AND CA-125 level must have at least doubled from baseline determination PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST or ALT no greater than 2.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No New York Heart Association Class III or IV heart disease No myocardial infarction within last 6 months No congestive heart failure No unstable angina No clinically significant pericardial effusion or arrhythmia Neurology: No current peripheral neuropathy of any etiology that is greater than grade 1 Other: No active serious infection or other serious underlying medical condition No prior significant allergic reactions to drugs containing Cremophor, such as teniposide, cyclosporin, or vitamin K Not pregnant or nursing Adequate contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since immunotherapy No concurrent immunotherapy Chemotherapy: Prior paclitaxel treatment must have been administered on a 3 week or greater schedule No other prior chemotherapy besides platinum and paclitaxel At least 3 weeks since acceptable chemotherapy Endocrine therapy: At least 3 weeks since hormonal therapy No concurrent hormonal therapy Radiotherapy: At least 3 weeks since radiotherapy No prior radiation to greater than 30% of bone marrow Surgery: At least 3 weeks since major surgery
|Official title||A Phase II Trial of Paclitaxel (Taxol) Administered as a Weekly One Hour Infusion in Patients With Taxol/Platinum-Refractory Stage III and IV Ovarian Cancer|
|Description||OBJECTIVES: I. Determine the objective response rate of paclitaxel given as a weekly one hour infusion in patients with paclitaxel/platinum refractory stage III and IV ovarian cancer. II. Evaluate the safety of paclitaxel in this patient population. III. Assess the overall survival in these patients. IV. Assess quality of life in these patients. OUTLINE: This is a multicenter, open label, nonrandomized study. Patients are administered paclitaxel as a one hour IV infusion every 7 days. Each cycle consists of four weeks. Treatment may be delayed for up to 2 weeks and there is no limit to the number of interruptions a patient may experience. Patients receive paclitaxel weekly until disease progression or unacceptable toxicity. Treatment is assessed every 3 cycles for one year and then every 6 months thereafter during study. Quality of life is assessed every cycle for the first 6 cycles, then every 3 cycles thereafter. Patients are followed every 3 months for survival. PROJECTED ACCRUAL: There will be 100 patients accrued into this study.|
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