• Objective tumor response rate [ Designated as safety issue: No ]
  
• Time to tumor progression [ Designated as safety issue: No ]
  

• Survival without local relapse [ Designated as safety issue: No ]
  
• Overall survival [ Designated as safety issue: No ]
  
• Tolerability [ Designated as safety issue: Yes ]
  

OBJECTIVES:

Primary

• Determine the objective tumor response rate and time to tumor progression in patients with locally advanced or metastatic adenocarcinoma of the stomach treated with docetaxel and epirubicin as first-line therapy.

Secondary

• Determine the survival without local relapse and overall survival of patients treated with this regimen.
• Determine the tolerance to this regimen in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive epirubicin IV over 30 minutes and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the stomach

  • Locally advanced or metastatic disease

• Measurable disease

  • At least 1 unidimensionally measurable target lesion at least 2 cm in diameter
• No known symptomatic brain metastases
• No bone metastases

PATIENT CHARACTERISTICS:

Age

• 18 to 75

Performance status

• ECOG 0-2

Life expectancy

• At least 3 months

Hematopoietic

• Absolute neutrophil count at least 2,000/mm^3
• Platelet count greater than 100,000/mm^3

Hepatic

• Bilirubin less than 2 times normal
• AST and ALT no greater than 2.5 times normal
• Alkaline phosphatase no greater than 2.5 times normal

Renal

• Creatinine less than 1.6 mg/dL OR
• Creatinine clearance greater than 60 mL/min

Cardiovascular

• No serious cardiac failure within the past 12 months
• No myocardial infarction within the past 12 months
• No cardiac insufficiency
• No angina

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No uncontrolled serious infection
• No significant brain or psychiatric disorders
• No intolerance to cortisone or polysorbate 80
• No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
• No other illness or medical condition that would preclude study participation
• No peripheral neuropathy greater than grade 2

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• More than 21 days since prior participation in another clinical study
• No other concurrent experimental medication