Combination Chemotherapy Regimens in Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
About this trial
This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, fallopian tube cancer, peritoneal cavity cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage IIB-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer No borderline ovarian tumors Residual disease allowed Fine needle aspiration showing an adenocarcinoma is allowed instead of open or true-cut biopsy if the following are true: Presence of pelvic mass AND Omental cake or other metastasis larger than 2 cm in the upper abdomen unless proven stage IV disease AND Serum CA 125/carcinoembryonic antigen ratio at least 25 (if less than 25, a barium enema or colonoscopy and gastroscopy or radiological examination of the stomach should be negative for primary tumor within 6 weeks of study) AND Normal mammography within 6 weeks of study PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: ECOG 0-1 Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count at least 2,000/mm^3 Platelet count at least 150,000/mm^3 Hepatic: Not specified Renal: Creatinine no greater than upper limit of normal Cardiovascular: No clinically relevant atrial or ventricular arrhythmias No myocardial infarction (MI) within the past 6 months (pretreatment ECG as only evidence of MI allowed) No history of second- or third-degree heart blocks unless pacemaker implanted History of first-degree heart block allowed Other: Not pregnant or nursing Fertile patients must use effective contraception No complete bowel obstruction No prior allergic reaction to drugs containing Cremophor EL or compounds chemically related to study drugs No condition that would preclude high-volume saline diuresis No significant neurologic or psychiatric disorder that would preclude study compliance No active uncontrolled infection No neuropathy greater than grade 1 No pre-existing hearing loss greater than grade 1 No other concurrent serious illness or medical condition that would preclude study participation No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biological response modifiers or immunotherapy No concurrent prophylactic colony-stimulating factors (CSFs) Concurrent therapeutic CSFs allowed Chemotherapy: No prior chemotherapy for ovarian cancer No other concurrent cytotoxic agents Endocrine therapy: No concurrent anticancer hormonal therapy Radiotherapy: No prior radiotherapy for ovarian cancer Surgery: No more than 6 weeks since prior planned pre-chemotherapy surgery for ovarian cancer Planned interval debulking allowed Concurrent second-look surgery allowed Other: No prior non-surgical therapy for ovarian cancer No other concurrent investigational drug therapy No other concurrent anticancer treatment Concurrent enrollment on CAN-NCIC-OV13/EORTC 55971 allowed
Sites / Locations
- Tom Baker Cancer Centre
- Cross Cancer Institute
- BCCA - Cancer Centre for the Southern Interior
- Lions Gate Hospital
- BCCA - Fraser Valley Cancer Centre
- BCCA - Vancouver Cancer Centre
- CancerCare Manitoba
- The Moncton Hospital
- Atlantic Health Sciences Corporation
- Dr. H. Bliss Murphy Cancer Centre
- QEII Health Sciences Center
- Juravinski Cancer Centre at Hamilton Health Sciences
- Cancer Centre of Southeastern Ontario at Kingston
- Grand River Regional Cancer Centre
- London Regional Cancer Program
- Ottawa Health Research Institute - General Division
- Niagara Health System
- Northeast Cancer Center Health Sciences
- Thunder Bay Regional Health Science Centre
- Univ. Health Network-Princess Margaret Hospital
- Windsor Regional Cancer Centre
- PEI Cancer Treatment Centre,Queen Elizabeth Hospital
- CHUM - Hopital Notre-Dame
- Hopital du Sacre-Coeur de Montreal
- CHUQ-Pavillon Hotel-Dieu de Quebec
- Centre hospitalier universitaire de Sherbrooke
- Allan Blair Cancer Centre
- Saskatoon Cancer Centre
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Cisplatin, Topotecan, Paclitaxel plus Carboplatin
Paclitaxel plus Carboplatin
Arm 1
Arm 2