Phase I/II Evaluation of Oral Estramustine and Oral Vinorelbine on an Intermittent Schedule in Patients With Hormone-Refractory Adenocarcinoma of the Prostate
Hormone Refractory prostate cancer refers to advanced disease in which a patient no longer
responds to conventional hormonal treatment. When hormone therapy is no longer successful,
chemotherapy is a treatment option. However, current single-agent treatment has shown to
have limited benefit. In this clinical trial, investigators are evaluating the effectiveness
of combining two chemotherapy drugs, Estramustine and Vinorelbine (Navelbine), in the
treatment of hormone refractory prostate cancer. Estramustine has been used in the treatment
of prostate cancer for many years. Vinorelbine has shown activity in prostate cancer. In
addition, the effect of this treatment on the quality of life of patients will be evaluated
as measured using the FACT-P.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the tolerable dose of oral vinorelbine in combination with oral estramustine on an intermittent schedule, and describe the toxicities of the regimen.
David C. Smith, MD
The University of Michigan Comprehensive Cancer Center
United States: Food and Drug Administration
|The University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109|