A Phase I Study of Paclitaxel, Carboplatin, and Increasing Doses of Doxil in Untreated Ovarian, Peritoneal, and Tubal Carcinoma

Date de début de l'étude : 1 mars 1999

DISEASE CHARACTERISTICS: Histologically confirmed previously untreated ovarian epithelial carcinoma, peritoneal carcinoma, or fallopian tube carcinoma The following histologic epithelial cell types are eligible: Serous adenocarcinoma Endometrioid adenocarcinoma Mucinous adenocarcinoma Undifferentiated carcinoma Clear cell adenocarcinoma Mixed epithelial carcinoma Transitional cell Malignant Brenner tumor Adenocarcinoma not otherwise specified No more than 12 weeks since diagnosis No ovarian epithelial carcinoma of low malignant potential (borderline carcinomas) PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Absolute granulocyte count at least 1,500/mm^3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT/SGPT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal Gamma-glutamyl-transferase no greater than 3 times normal No acute hepatitis Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance greater than 50 mL/min Cardiovascular: LVEF normal by MUGA No unstable angina No myocardial infarction within the past 6 months Patients with abnormal cardiac conduction (e.g., bundle branch block or heart block) are eligible if disease has been stable for the past 6 months Other: No septicemia or severe infection No severe gastrointestinal bleeding No other invasive malignancy within the past 5 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Recovered from recent prior surgery Other: No prior anticancer therapy that would preclude study