Study of Bortezomib and Docetaxel for Patients With Hormone Refractory Prostate Cancer
This study is for patients who have been treated with surgical removal of the testes or hormone therapy (Lupron or Zoladex) and whose prostate cancer has worsened despite this treatment.
PS 341 is a type of drug known as a "proteasome inhibitor." By inhibiting the "proteasome" in cancer cells, PS-341 alters the way those cells divide). We hope to learn whether this combination chemotherapy decreases cancer symptoms and tests (prostate specific antigen, also called PSA), and to determine how frequently serious side effects might occur with this treatment for this stage of prostate cancer.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Bortezomib (Velcade®, PS-341) and Docetaxel for Patients With Hormone Refractory Prostate Cancer|
- Number of patients with improved serum PSA response rate [ Time Frame: Every end of each cycle (21 days) up to 12 cycles ] [ Designated as safety issue: Yes ]Participants should be reevaluated for PSA response every 21 days. A confirmatory PSA level should be obtained 3-4 weeks following initial documentation of a PSA response.
- Pain response rate [ Time Frame: At baseline, then weekly for 4 weeks up to 36 weeks ] [ Designated as safety issue: Yes ]Participants will be considered evaluable for a pain response if the baseline analgesic use was determined, and at least 4 weekly assessments of PPI and analgesic score are available from any 8-week period from the period after the initiation of therapy until discontinuation of study medication.
|Study Start Date:||April 2005|
|Study Completion Date:||December 2011|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Experimental: Bortezomib and Docetaxel
Bortezomib 1.6 mg/m2 Docetaxel 75 mg/m2
Drug: PS 341
PS 341 1.6 mg/m2 IV (in the vein) on days 1 and 8 of each 21 day cycle up to 12 cycles.
Other Names:Drug: Docetaxel
Docetaxel 75mg/m2 IV (in the vein) on day 1 of each 21 day cycle up to 12 cycles.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00183937
|United States, California|
|USC/Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||David Quinn, MD||University of Southern California|