- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00193232
Weekly Docetaxel and Bortezomib in the Treatment of Advanced Hormone-Refractory Prostate Cancer
A Phase II Trial of Weekly Docetaxel and Bortezomib (Velcade; PS-341) in the Treatment of Patients With Advanced Hormone-Refractory Prostate Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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 progression is documented.
Study Type
Enrollment
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
objective response rate
|
Secondary Outcome Measures
Outcome Measure |
---|
overall survival
|
progression-free survival
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCRI GU 18
- IIT16160
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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