Spots Global Cancer Trial Database for Liposomal Doxorubicin in Treating Patients With Advanced Stomach Cancer

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Trial Identification

Brief Title: Liposomal Doxorubicin in Treating Patients With Advanced Stomach Cancer

Official Title: A Phase II Study of Caelyx in the Treatment of Advanced Gastric Cancer

Study ID: NCT00004236

Conditions

Esophageal Cancer

Gastric Cancer

Interventions

pegylated liposomal doxorubicin hydrochloride

Study Description

Brief Summary: 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.

Detailed Description: 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. 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.