A Phase II Study of Caelyx in the Treatment of Advanced Gastric 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.
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.
Primary Purpose: Treatment
Kenneth O'Byrne, MD
University Hospitals, Leicester
United States: Federal Government