Status:
COMPLETED
Oral Estramustine and Oral Vinorelbine in the Treatment of Hormone-Refractory Prostate Cancer
Lead Sponsor:
University of Michigan Rogel Cancer Center
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 refrac...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Inclusion:
- 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 (Prostate Specific Antigen) 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). If PSA is the only evidence of progressive disease it must be greater than or equal to 4ng/mL.
- Adequate bone marrow, renal and liver function
- ECOG (Eastern Cooperative Oncology Group) performance status of 0-2 (a measure of general well being on a scale of 0-5 where 0 represents asymptomatic and 5 represents death)
- Must be at least 18 years of age
- Must have a life expectancy of greater than or equal to 12 weeks
- Exclusion:
- Have previously received vinca alkaloid-based cytotoxic chemotherapy or radiation to greater than or equal to 50% of the total bone marrow.
- Evidence of brain metastasis
- Spinal cord compression
- Prior malignancy except for in situ carcinoma, nonmelanoma skin cancer, or adequately treated malignancy that has been inactive for less than 3 years
- Patients with preexisting neuropathy of greater than or equal to grade 2
- Active gastrointestinal disease, or a disorder that alters gastrointestinal motility or absorption
Exclusion
Key Trial Info
Start Date :
December 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00151086
Start Date
December 1 2001
End Date
August 1 2006
Last Update
January 22 2015
Active Locations (1)
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1
The University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109