Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Primary Peritoneal Carcinoma, Stage III Ovarian Cancer, Stage IV Ovarian Cancer
About this trial
This is an interventional treatment trial for Primary Peritoneal Carcinoma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed stage III or IV ovarian epithelial or serous primaryperitoneal carcinoma The following are ineligible: Germ cell tumors Sex cord-stromal tumors Carcinosarcomas Mixed Mullerian tumors or carcinosarcomas Metastatic carcinomas from other sites to theovary Low malignant potential tumors, including micropapillary serouscarcinomas Mucinous primary peritoneal carcinoma Prior ovarian low malignant potential tumor (borderline carcinoma) that was surgically resected with subsequent development of invasive adenocarcinoma allowed if no prior chemotherapy Optimal (no greater than 1 cm) or suboptimal residual disease after initial surgery Prior breast cancer allowed provided the following are true: Disease-free for more than 5 years No prior cytotoxic chemotherapy for breast cancer Prior or concurrent primary endometrial cancer allowed if the following conditions are met: Stage no greater than IB Less than 3 mm invasion without vascular or lymphatic invasion No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO grade 3 lesions Performance status - GOG 0-2 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN No acute hepatitis Creatinine no greater than 1.5 times ULN No unstable angina No myocardial infarction within the past 6 months No evidence of abnormal cardiac conduction (e.g., bundle branch block, heart block) unless stable for the past 6 months Not pregnant or nursing Fertile patients must use effective contraception No greater than grade 1 sensory or motor neuropathy No active infection that requires antibiotics No other invasive malignancy within the past 5 years except nonmelanoma skin cancer No severe or ongoing gastrointestinal bleeding that requires blood product support See Disease Characteristics Prior chemotherapy for cancer involving the abdominal cavity or pelvis allowed provided the following are true: More than 3 years since prior therapy No evidence of recurrent disease No prior radiotherapy to any portion of the abdominal cavity or pelvis Prior radiotherapy for localized breast, head and neck, or skin cancer allowed provided the following are true: More than 3 years since prior therapy No evidence of recurrent disease See Disease Characteristics No more than 12 weeks since prior surgical resection
Sites / Locations
- Gynecologic Oncology Group
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Active Comparator
Experimental
Experimental
Experimental
Experimental
Arm I
Arm II
Arm III
Arm IV
Arm V
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment continues every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and gemcitabine IV over 30 minutes on days 1 and 8.
Patients receive chemotherapy as in arm I during courses 1-8 and doxorubicin HCl liposome IV over 1 hour on day 1 during courses 1, 3, 5, and 7. Treatment continues as in arm I.
Patients receive topotecan IV over 30 minutes on days 1-3 and carboplatin IV over 30 minutes on day 3. Treatment continues every 3 weeks for 4 courses. Patients then receive 4 courses of arm I chemotherapy.
Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 8. Treatment continues every 3 weeks for 4 courses. Patients then receive 4 courses of arm I chemotherapy. Patients with initial unresectable or suboptimal residual disease (more than 1 cm) may undergo interval cytoreductive surgery between courses 4 and 5 of chemotherapy.