Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
About this trial
This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer
Eligibility Criteria
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
Sites / Locations
- Oncology Center at Providence Park
- Hematology Associates, Ltd.
- Highlands Oncology Group, P.A.
- Cancer Center of Santa Barbara
- Good Samaritan Medical Center
- Decatur Memorial Hospital Cancer Care Institute
- Creighton University Cancer Center
- Jersey Shore Cancer Center
- Women's Health Center at Albany Medical Center
- Carolinas Medical Center
- Akron General Medical Center
- Oncology/Hematology Care, Inc.
- Cleveland Clinic Cancer Center
- Women's Cancer Center of Central PA, P.C.
- Women and Infants Hospital of Rhode Island
- Brookview Research, Inc.
- Harrington Cancer Center
- Rockwood Clinic P.S.