Randomized Phase II Trial of Either 5-Fluorouracil, Recombinant Alfa-2a-Interferon and Intravenous Hydroxyurea With Filgrastim Support (FHIG) or Doxorubicin/Docetaxel (Dd) in Patients With Advanced Gastric Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the stomach or
gastroesophageal junction beyond the scope of surgical resection Must have measurable
disease in either one or two dimensions either radiographically or by physical examination
Measurable disease must be documented outside of a prior radiation portal Evaluable
disease only not allowed

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy:
Not specified Hematopoietic: WBC greater than 4,000/mm3 Absolute neutrophil count greater
than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than
upper limit of normal (ULN) SGOT no greater than 1.5 times ULN Alkaline phosphatase no
greater than 5 times ULN Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No New York
Heart Association class III or IV heart disease No chronic or unstable angina No
uncontrolled congestive heart failure No arrhythmia No chronic angina No myocardial
infarction in the past 1 year If history of atherosclerotic heart disease, prior cardiac
catheterization or thallium stress test must not suggest coronary artery disease
Neurology: No symptomatic peripheral neuropathy greater than grade 2 No cerebellar disease
No seizure disorder No organic mental syndrome No major psychoaffective disorder
Pulmonary: No chronic obstructive pulmonary disease No chronic bronchitis, emphysema,
sarcoid, or bronchiectasis Other: No poorly controlled diabetes mellitus No psychiatric
illness No active infections, including AIDS, ARC, or HIV positive No history of
hypersensitivity to products containing Polysorbate 80 No history of uncontrolled alcohol
or drug abuse No uncontrolled hypercalcemia No other prior malignancy within the past 5
years other than nonmelanomatous skin cancer or cervical carcinoma in situ Not pregnant or
nursing Adequate contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No
prior systemic chemotherapy Endocrine therapy: No chronic use of steroids No concurrent
hormonal therapy (except birth control pills) Radiotherapy: At least 1 month since prior
radiotherapy No concurrent palliative radiotherapy (arm I patients) Surgery: Must have
fully recovered from surgery Other: At least 4 weeks since other investigational agents
and recovered from all toxic effects No chronic use of aspirin, nonsteroidal
antiinflammatory agents, antianginal medications, or extraordinary antihypertensive
regimens