Topotecan in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
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 recurrent ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer Recurrent disease Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan At least 1 target lesion not in a previously irradiated field Received 1, and only 1, prior platinum-based chemotherapy regimen for primary disease containing carboplatin, cisplatin, or other organoplatinum compound Initial treatment may have included high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment Patients who have not received prior paclitaxel may receive a second regimen that includes paclitaxel Platinum-sensitive disease Treatment-free interval* without clinical evidence of progressive disease for > 6 months after prior response to a platinum-based regimen NOTE: *Non-platinum maintenance or consolidation therapy is not included in calculation of the treatment-free interval Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population) PATIENT CHARACTERISTICS: Age 18 and over Performance status GOG 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) SGOT ≤ 2.5 times ULN Alkaline phosphatase ≤ 2.5 times ULN Renal Creatinine ≤ 1.5 times ULN Creatinine clearance > 40 mL/min Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No sensory or motor neuropathy > grade 1 No active infection requiring antibiotics No other invasive malignancy within the past 5 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy At least 3 weeks since prior biologic or immunologic agents for the malignancy No more than 1 prior non-cytotoxic (biologic or cytostatic) regimen (e.g., monoclonal antibodies, cytokines, or small molecule inhibitors of signal transduction) for recurrent disease No concurrent cytokines during the first course of study treatment No concurrent pegfilgrastim Chemotherapy See Disease Characteristics See Biologic therapy Recovered from prior chemotherapy No other prior cytotoxic chemotherapy for recurrent disease, including retreatment with initial chemotherapy regimen No prior topotecan Endocrine therapy At least 1 week since prior hormonal therapy for the malignancy Concurrent hormone replacement therapy allowed Radiotherapy See Disease Characteristics Recovered from prior radiotherapy No prior radiotherapy to > 25% of marrow-bearing areas Surgery Recovered from prior surgery Other At least 3 weeks since other prior therapy for the malignancy No prior anticancer therapy that would preclude study treatment
Sites / Locations
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
- George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
- Tunnell Cancer Center at Beebe Medical Center
- CCOP - Christiana Care Health Services
- Washington Cancer Institute at Washington Hospital Center
- MBCCOP - Medical College of Georgia Cancer Center
- Rush-Copley Cancer Care Center
- University of Illinois Cancer Center
- Rush University Medical Center
- Hinsdale Hematology Oncology Associates
- Joliet Oncology-Hematology Associates, Limited - West
- Advocate Lutheran General Cancer Care Center
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- Saint Anthony Memorial Health Centers
- Holden Comprehensive Cancer Center at University of Iowa
- Woman's Hospital
- Union Hospital Cancer Program at Union Hospital
- Tufts-NEMC Cancer Center
- UMASS Memorial Cancer Center - University Campus
- Saint Joseph Mercy Cancer Center
- CCOP - Michigan Cancer Research Consortium
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Foote Memorial Hospital
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Sparrow Regional Cancer Center
- St. Mary Mercy Hospital
- St. Joseph Mercy Oakland
- Mercy Regional Cancer Center at Mercy Hospital
- William Beaumont Hospital - Royal Oak Campus
- Seton Cancer Institute at Saint Mary's - Saginaw
- St. John Macomb Hospital
- University of Mississippi Cancer Clinic
- Saint Louis University Cancer Center
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
- CCOP - Cancer Research for the Ozarks
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- Cancer Resource Center - Lincoln
- CCOP - Missouri Valley Cancer Consortium
- Methodist Estabrook Cancer Center
- Jersey Shore Cancer Center at Jersey Shore University Medical Center
- Cancer Institute of New Jersey at Cooper - Voorhees
- SUNY Downstate Medical Center
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
- Stony Brook University Cancer Center
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- Blumenthal Cancer Center at Carolinas Medical Center
- Wake Forest University Comprehensive Cancer Center
- McDowell Cancer Center at Akron General Medical Center
- Case Comprehensive Cancer Center
- Cleveland Clinic Cancer Center at Fairview Hospital
- Cleveland Clinic Taussig Cancer Center
- Riverside Methodist Hospital Cancer Care
- Mount Carmel Health - West Hospital
- Hillcrest Cancer Center at Hillcrest Hospital
- Lake/University Ireland Cancer Center
- Oklahoma University Cancer Institute
- Cancer Care Associates - Midtown Tulsa
- Rosenfeld Cancer Center at Abington Memorial Hospital
- Bryn Mawr Hospital
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- Cancer Center of Paoli Memorial Hospital
- Fox Chase Cancer Center - Philadelphia
- McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
- CCOP - MainLine Health
- Lankenau Cancer Center at Lankenau Hospital
- Avera Cancer Institute
- Sanford Cancer Center at Sanford USD Medical Center
- Harrington Cancer Center
- Marshfield Clinic - Marshfield Center
- Marshfield Clinic - Indianhead Center
- Marshfield Clinic - Weston Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Topotecan 1.25 mg/m2 IV days 1-5 of a 21 day cycle
Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28 day cycle
Topotecan 1.25 mg/m2 IV days 1-5 of a 21 day cycle until disease progression or adverse effects prohibit further therapy
Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28 day cycle until disease progression or adverse effects prohibit further therapy