Trials / Completed
CompletedNCT00064610
Phase I/II Dose Escalation Study of VELCADE® and Docetaxel in Patients With Advanced Androgen-Independent Prostate Cancer
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 102 (planned)
- Sponsor
- Millennium Pharmaceuticals, Inc. · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | VELCADE TM (bortezomib) for Injection |
Timeline
- Start date
- 2002-12-01
- Primary completion
- 2004-12-01
- First posted
- 2003-07-11
- Last updated
- 2008-02-11
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00064610. Inclusion in this directory is not an endorsement.