Taxotere-Cisplatin-5FU (TCF) Versus Taxotere-Cisplatin (TC) Versus Epirubicin-Cisplatin-5FU (ECF) as Systemic Treatment for Advanced Gastric Carcinoma: A Randomized Phase II Trial

Date de début de l'étude : 1 août 1999

DISEASE CHARACTERISTICS: Histologically confirmed gastric carcinoma not amenable to curative surgery or in relapse after primary surgical resection Locally advanced disease (i.e., measurable locoregional lymph nodes) OR Metastatic disease Bidimensionally measurable disease At least 10 mm X 20 mm by chest x-ray or physical examination At least 10 mm X 10 mm by CT scan No CNS metastasis PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: 0-1 Life expectancy: Greater than 12 weeks Hematopoietic: WBC count at least 4,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) AST/ALT no greater than 2.5 times ULN Alkaline phosphatase no greater than 5 times ULN Renal: BUN normal Creatinine normal Creatinine clearance at least 60 mL/min No severe hypercalcemia Cardiovascular: No unstable cardiac disease requiring treatment No congestive heart failure No angina pectoris even if medically controlled No significant arrhythmias No prior myocardial infarction unless ejection fraction at least 50% by MUGA scan or echocardiogram Neurologic: No prior significant neurologic or psychiatric disorders, including psychotic disorders, dementia or seizures that would preclude study No peripheral neuropathy of any origin (alcohol, etc.) greater than grade 1 Other: Fertile patients must use adequate contraception No prior malignancy except basal cell skin cancer or adequately treated carcinoma in situ of the cervix No active uncontrolled infection No other serious illness or medical condition that would preclude study participation No contraindication to corticosteroid use PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior palliative chemotherapy At least 12 months since prior adjuvant or neoadjuvant chemotherapy No prior taxanes Prior fluorouracil allowed in bolus form only Prior cumulative dose of adjuvant or neoadjuvant cisplatin no greater than 300 mg/m2 Endocrine therapy: Prior or concurrent prednisone (or equivalent) allowed for prophylaxis, acute hypersensitivity reactions, or chronic therapy (greater than 6 months) at doses no greater than 20 mg Radiotherapy: Not specified Surgery: See Disease Characteristics Other: No other concurrent experimental drugs No other concurrent anticancer therapies At least 30 days since treatment in prior clinical trial