Status:
COMPLETED
Estramustine, Docetaxel and Zoledronate Treatment in Hormone-Refractory Adenocarcinoma of the Prostate
Lead Sponsor:
University of Michigan Rogel Cancer Center
Collaborating Sponsors:
Aventis Pharmaceuticals
Novartis
Conditions:
Hormone-Refractory Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
Purpose: The aim of this clinical trail is to evaluate the effectiveness of Zoledronate (Zometa) combined with Estramustine and Docetaxel (Taxotere) in the treatment of patients with hormone-refractor...
Detailed Description
Hormone refractory prostate cancer refers to advanced disease in which the patient no longer responds to conventional hormonal treatment. When hormone therapy is no longer successful, chemotherapy is ...
Eligibility Criteria
Inclusion
- All patients must have a histologic diagnosis of hormone-refractory adenocarcinoma of the prostate, and hormone refractory disease must be demonstrated by the appearance of new lesions on bone or CT scan and/or a rising PSA value. (No evidence of brain metastasis or untreated spinal cord compression.)
- Patients on total androgen suppression therapy must undergo nonsteroidal antiandrogen withdrawal and demonstrate a rising PSA 4 weeks after withdrawal from flutamide and 6 weeks after withdrawal from bicalutamide.
- Patient must not be undergoing current chemotherapy, biologic therapy, other investigational or alternative anti-cancer directed therapy or radiation therapy.
- Prior radiation therapy must have completed more than 4 weeks prior to registration.
- Patients may not have received prior taxane-based cytotoxic chemotherapy for hormone refractory disease.
Exclusion
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00151073
Start Date
April 1 2002
End Date
September 1 2007
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