Status:
COMPLETED
Weekly Docetaxel and Bortezomib in the Treatment of Advanced Hormone-Refractory Prostate Cancer
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Aventis Pharmaceuticals
Millennium Pharmaceuticals, Inc.
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
Evaluation of the effectiveness of weekly docetaxel/bortezomib as first-line chemotherapy for patients with advanced hormone-refractory prostate cancer.
Detailed Description
Upon determination of eligibility, patients will be receive: * Docetaxel + Bortezomib Patients with objective responses or stable disease will continue treatment for eight courses or until disease p...
Eligibility Criteria
Inclusion
- Prostate cancer, and objective evidence of metastatic disease
- Progression while receiving androgen ablation therapy
- No previous chemotherapy
- Measurable or evaluable disease in conjunction with elevated serum PSA levels
- ECOG performance status 0, 1, or 2
- Adequate bone marrow, liver and kidney function
- Voluntarily provide written informed consent
Exclusion
- You cannot participate in this study if any of the following apply to you:
- Moderate or severe peripheral neuropathy
- Age \< 18 years
- Other serious medical conditions that may interfere with protocol therapy
- Other active malignancies
- history of treatment for other invasive cancers within 3 years
- Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
February 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00193232
Start Date
May 1 2004
End Date
February 1 2007
Last Update
July 28 2010
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