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

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 Vinorelbine
    Treatment 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)

FacilityCityStateZIPSite coordinators
The University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-

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