RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating patients who have advanced stomach cancer.

OBJECTIVES: I. Determine overall survival, time to disease progression, objective reponse rate, safety profile, and quality of life in patients with inoperable gastric adenocarcinoma when treated with doxorubicin HCl liposome.

PROTOCOL OUTLINE: Patients receive doxorubicin HCl liposome IV over 1 hour every 4 weeks. Treatment continues for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients with responding disease may continue therapy past the 6 courses until documented disease progression. Quality of life is assessed prior to every treatment course. All patients are followed at 1 month. Patients with stable or responding disease are then followed every 3 months until death.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 24 months.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically or cytologically confirmed advanced gastric adenocarcinoma, including adenocarcinoma of the esophagogastric junction
• Evaluable disease
• No CNS involvement

--Prior/Concurrent Therapy--

• Biologic therapy: No concurrent immunotherapy
• Chemotherapy: No prior chemotherapy for metastatic disease; No other concurrent chemotherapy
• Endocrine therapy: Not specified
• Radiotherapy: At least 4 weeks since prior radiotherapy to less than 1/3 of hematopoietic sites and recovered
• Surgery: Not specified
• Other: At least 30 days since other prior investigational agents

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-2
• Life expectancy: At least 12 weeks
• Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9 g/dL
• Hepatic: Bilirubin normal; AST or ALT less than 3 times upper limit of normal (ULN) (5 times ULN if documented liver metastases)
• Renal: Creatinine less than 1.5 times ULN
• Cardiovascular: LVEF normal; No history of New York Heart Association class II-IV heart disease with congestive heart failure; No unstable cardiovascular disease
• Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No other prior primary cancer within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix; No hypersensitivity to anthracycline therapy; No history of severe hypersensitivity reactions to products containing Chremophor EL (e.g., cyclosporine or teniposide for injection concentrate); No other significant medical disorder (e.g., active uncontrolled infection) that would preclude study treatment