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

Inclusion Criteria

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