Status:
COMPLETED
Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Dana-Farber Cancer Institute
Conditions:
Adenocarcinoma of the Prostate
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study it to learn the effects (good or bad) that rosiglitazone has on patients and their prostate cancer. This study is going to look at what effects rosiglitazone has on prostate ...
Detailed Description
* Patients will be randomly assigned to initial treatment with either rosiglitazone or placebo orally twice daily, every day as long as there is no disease progression or serious side effects. Patient...
Eligibility Criteria
Inclusion
- Histologically confirmed adenocarcinoma of the prostate
- Biochemical disease progression following local therapy defined as three rises in PSA with each PSA determination at least 4 weeks apart and each PSA value \> or = 0.2ng/ml
- For men treated with radical prostatectomy, PSA \> or = 2 ng/ml
- For men treated with primary radiation therapy or post-prostatectomy radiation therapy, PSA \> or = 2 ng/ml and \> 150% post-radiation nadir
- Not an appropriate candidate for salvage radiation therapy or salvage prostatectomy
- Baseline PSADT \< 24 months
- CALGB performance status of 0,1 or 2
Exclusion
- Metastatic disease
- Prior hormonal therapy for recurrent prostate cancer
- Prior chemotherapy for prostate cancer
- Current treatment with insulin or an oral hypoglycemic
- History of treatment with thiazolidinediones
- Radiation therapy within 6 months
- SGOT \> 1.5 x ULN
- Fasting blood glucose \< 60 mg/dl
- NYHA Class 3 or 4 cardiac status
Key Trial Info
Start Date :
September 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2003
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00182052
Start Date
September 1 2000
End Date
August 1 2003
Last Update
May 23 2013
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115