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Sponsored by: |
Millennium Pharmaceuticals |
Information provided by: | Millennium Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00064610 |
The purpose of this study is to evaluate how safe PS-341(VELCADE) is when given with Docetaxel (Taxotere) to patients with androgen-independent prostate cancer, and also to see what effects (good and bad) it has on you and on your cancer.
Condition | Intervention | Phase |
Prostatic Neoplasms |
Drug: VELCADE TM (bortezomib) for Injection |
Phase I Phase II |
MedlinePlus related topics: | Cancer Prostate Cancer |
ChemIDplus related topics: | Docetaxel Bortezomib |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II, Open Label, Dose Escalation Study to Determine the Tolerance and Preliminary Activity of PS-341 Plus Docetaxel in Patients With Advanced Androgen-Independent Prostate Cancer Requiring Chemotherapy |
Estimated Enrollment: | 102 |
Study Start Date: | December 2002 |
Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
This is a dose escalation study, which means that the first group of patients will receive a low dose of PS-341 (VELCADE) and Docetaxel (Taxotere). If the low dose of VELCADE and Taxotere appears to be safe, then the next group of patients will receive a higher dose of VELCADE and Taxotere.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion criteria
Each patient must meet all of the following inclusion criteria to be enrolled in the study:
Patient has progressive measurable or evaluable disease, defined as meeting at least one of the following three criteria [1]:
Progressive PSA, as evidenced by two separate measurements taken at least one week apart and confirmed by a third, and if necessary, a fourth measurement.
Exclusion criteria Patients meeting any of the following exclusion criteria are not to be enrolled in the study.
Patient has any of the following pretreatment laboratory data within 14 days before the first study drug dose:
United States, California | |||||
Cedars Sinai Medical Center | |||||
Los Angeles, California, United States, 90048 | |||||
United States, New York | |||||
Columbia-Presbyterian Hospital | |||||
New York, New York, United States, 10032 | |||||
United States, Ohio | |||||
Cleveland Clinic Foundation | |||||
Cleveland, Ohio, United States, 44195 | |||||
United States, Tennessee | |||||
Vanderbilt University Medical Center | |||||
Nashville, Tennessee, United States, 37232 |
Millennium Pharmaceuticals |
Study ID Numbers: | M34101-033 |
First Received: | July 10, 2003 |
Last Updated: | February 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00064610 |
Health Authority: | United States: Food and Drug Administration |
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