Oral Estramustine and Oral Vinorelbine in the Treatment of Hormone-Refractory Prostate Cancer
Part of paid clinical trials in Ann Arbor, Michigan.
- Sponsor
- University of Michigan Rogel Cancer Center
- Study ID
- NCT00151086
- Phase
- PHASE1/PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Estramustine — DRUG
- Vinorelbine — DRUG
Study Details
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.
Key Dates
- Start date
- Dec 31, 2001
- Status verified
- Jan 2015
- Primary completion
- Mar 31, 2004
- Completion
- Aug 31, 2006
Study Design
- Enrollment
- 33 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Estramustine and VinorelbineTreatment will consist of 28-day cycles with estramustine at a dose of 140mg orally 3 times per day on days 1-3 and 8-10 and vinorelbine orally on days 2 and 9 beginning at dose 50mg/m\^2.
Primary Outcome Measure
Tolerable Dose of Vinorelbine in Combination with Estramustine [ Time Frame: 180 days post dose ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | - |
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