Liposomal Doxorubicin in Treating Patients With Advanced Stomach Cancer
Recruitment status was Active, not recruiting
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.
Drug: pegylated liposomal doxorubicin hydrochloride
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Study of Caelyx in the Treatment of Advanced Gastric Cancer|
|Study Start Date:||August 1998|
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.
|University Hospitals of Leicester|
|Leicester, England, United Kingdom, LE1 5WW|
|Study Chair:||Kenneth O'Byrne, MD||University Hospitals, Leicester|