Master Protocol for Metastatic Hormone-Resistant Prostatic Carcinoma - Phase II Trials - Protocol 5: Capecitabine
OBJECTIVES: I. Determine the efficacy of capecitabine in terms of PSA response, PSA response
duration, and time to PSA progression in patients with metastatic hormone refractory
prostate cancer. II. Evaluate the toxicity of this treatment in these patients. III.
Evaluate the correlation between PSA response and quality of life in these patients.
OUTLINE: This is a multicenter study. Patients receive oral capecitabine twice daily on days
1-14. Treatment continues every 21 days for up to 8 courses in the absence of disease
progression or unacceptable toxicity. Quality of life is assessed on days 1 and 8 of the
first course of treatment, on day 1 of each course thereafter, and at treatment failure.
Patients are followed every 3 months until disease progression.
PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.
Primary Purpose: Treatment
Rudolf Morant, MD
Kantonsspital St. Gallen