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Rosiglitazone (Avandia) vs Placebo for Androgen-Dependent Prostate Cancer

Information source: Memorial Sloan-Kettering Cancer Center
Information obtained from ClinicalTrials.gov on June 01, 2007
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: Rosiglitazone (Avandia) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Memorial Sloan-Kettering Cancer Center

Official(s) and/or principal investigator(s):
Susan Slovin, M.D, Principal Investigator, Affiliation: Memorial Sloan-Kettering Cancer Center

Summary

The purpose of this study is to see what effects the drug Rosiglitazone has on you and your prostate cancer. In particular, the study is also looking at the impact of the drug on Prostate Specific Antigen (PSA). PSA is a marker in your blood that is used to follow the progress of your disease.

Clinical Details

Official title: Rosiglitazone (Avandia) vs Placebo for Androgen-Dependent Prostate Cancer: A Randomized, Double-Blind, Placebo-Controlled Phase III Study

Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: To compare the proportion of evaluable men who respond to rosiglitazone compared to the proportion of evaluable men who respond to placebo.

Secondary outcome: To compare time to progression between patients treated with rosiglitazone and those treated with placebo.

Detailed description: Rosiglitazone is a drug approved for the treatment of diabetes. It is similar to another drug that was given to prostate cancer patients. The PSA level went down in some of these patients. We do not know if this meant that the cancer was quiet and not getting worse or whether the drug would prevent the cancer from coming back. The drug in this study, rosiglitazone is more powerful in the way it stops cell growth and it has fewer side effects. We are studying this drug to see if it is more effective in treating prostate cancer that does not show up on scans and in keeping your PSA level from rising. The primary objective is to evaluate the activity of rosiglitazone by comparing changes in PSA doubling time (PSADT) between rosiglitazone-¬treated and placebo-treated men with androgen-dependent prostate cancer. The secondary objective will be to evaluate time to PSA progression as a secondary measure of the activity of rosiglitazone.

Eligibility

Gender(s): Male.

Criteria:

Inclusion Criteria:

- 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 >=0. 2 ng/mL.

- For men treated with radical prostatectomy, PSA >=2 ng/mL.

- For men treated with primary radiation therapy or post-prostatectomy radiation therapy, PSA >=2 ng/ml and >150% post-radiation nadir.

- For men who are not an appropriate candidate for salvage radiation therapy or salvage prostatectomy.

- Baseline PSADT <24 months .

- CALGB performance status 0, 1 or 2.

- Signed informed consent.

Exclusion Criteria:

- Metastatic disease.

- Prior hormonal therapy for recurrent prostate cancer (neoadjuvant/adjuvant hormonal therapy completed >1 year prior to study entry is allowed).

- Prior chemotherapy for prostate cancer.

- Current treatment with insulin or an oral hypoglycemic 3. 2.5 History of treatment with a thiazolidinediones.

- Radiation therapy within 6 months.

- SGPT (ALT) > 1. 5 times upper limit of normal.

- Fasting blood glucose < 60 mg/dL.

- NYHA Class 3 or 4 cardiac status.

Locations and Contacts

Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States
Additional Information

Memorial Sloan-Kettering Cancer Center

Starting date: May 2002
Last updated: May 29, 2007

Page last updated: June 01, 2007

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