NCT Number: NCT00193232
Weekly Docetaxel and Bortezomib in the Treatment of Advanced Hormone-Refractory Prostate Cancer
Evaluation of the effectiveness of weekly docetaxel/bortezomib as first-line chemotherapy for patients with advanced hormone-refractory prostate cancer.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
Male
Study type
Interventional
Phase
Phase 2
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
bortezomib
DrugPrimary outcomes
-
objective response rate
Secondary outcomes
-
progression-free survival
-
overall survival
Sponsors and collaborators
Lead sponsor
SCRI Development Innovations, LLC
Other
Collaborators
- Aventis Pharmaceuticals
- Millennium Pharmaceuticals, Inc.
Registry information
Official study title
A Phase II Trial of Weekly Docetaxel and Bortezomib (Velcade; PS-341) in the Treatment of Patients With Advanced Hormone-Refractory Prostate Cancer
Important dates
- Study start
- 2004
- Primary completion
- 2005
- Study completion
- 2007
- First posted
- Sep 19, 2005
- Registry last updated
- Jul 28, 2010
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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