Master Protocol for Metastatic Hormone-Resistant Prostatic Carcinoma Phase II Trials Protocol 4: Vinorelbine
OBJECTIVES: I. Evaluate the efficacy of vinorelbine in patients with metastatic
hormone-resistant prostate cancer. II. Evaluate the toxicity of vinorelbine in these
patients. III. Evaluate the quality of life of these patients, and correlate quality of life
with PSA response.
OUTLINE: Patients receive a 5-10 minute intravenous infusion of vinorelbine on day 1 and day
8 of a 21-day course. Patients with stabilization of their disease, partial response, or
complete response, receive a maximum of 12 courses of treatment. Patients showing disease
progression or severe toxic side effects discontinue treatment. Quality of life and pain are
assessed prior to treatment, at days 1 and 8 of each course, and at end of the treatment.
Patients are followed every 3 months until disease progression.
PROJECTED ACCRUAL: A total of 14-40 patients will be accrued for this study.
Primary Purpose: Treatment
Rudolf Morant, MD
Kantonsspital St. Gallen