Purpose: This clinical trail will combine the chemotherapy drugs, Estramustine and Vinorelbine (Navelbine), on an intermittent therapy strategy based on PSA response in the treatment of hormone refractory prostate cancer. The investigators will determine the tolerable dose of (oral) vinorelbine in combination with (oral)estramustine, and evaluate the efficacy of this treatment for patients with hormone-refractory prostate cancer.

Condition	Intervention	Phase
Prostate Cancer	Drug: Oral Estramustine  Drug: Oral Vinorelbine	Phase I Phase II

Further Study Details: 

Primary Outcomes: To determine the tolerable dose of oral vinorelbine in combination with oral estramustine on an intermittent schedule, and describe the toxicities of the regimen.
Expected Total Enrollment:  30

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Male

Criteria

Patients must have a histologic diagnosis of adenocarcinoma of the prostate. (No evidence of brain metastasis or untreated spinal cord compression.)

Patients on total androgen suppression therapy must undergo nonsteroidal antiandrogen withdrawal and demonstrate at rising PSA 4 weeks after withdrawal for flutamide and 6 weeks after withdrawal for bicalutamide or nilutamide.

Patients must have measurable soft tissue disease or evaluable (abnormal bone scan and/or elevated PSA).

Michigan
      The University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109,  United States

Study chairs or principal investigators

David C. Smith, MD,  Principal Investigator,  The University of Michigan Comprehensive Cancer Center   

Study ID Numbers:  UMCC 2001-050
Last Updated:  September 7, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00151086
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13