Name of the Trial
Phase II Study of Docetaxel, Bevacizumab, Thalidomide, and Prednisone in Patients with Metastatic Androgen-Independent Adenocarcinoma of the Prostate (NCI-04-C-0257). See the protocol summary at http://cancer.gov/clinicaltrials/NCI-04-C-0257.

Principal Investigator
Dr. William Dahut, NCI CCR

Why This Trial Is Important
Hormonal therapy for prostate cancer removes or blocks the action of hormones (androgens) that trigger prostate cancer cell growth. In most patients, prostate cancer that has spread (metastasized) to other parts of the body responds dramatically to hormonal therapy. However, over time, prostate tumors acquire the ability to grow without the help of hormones. This is called androgen-independent prostate cancer.

Clinical trials have shown that chemotherapy with the drug docetaxel improves the survival of men with metastatic, androgen-independent prostate cancer. Currently, the combination of docetaxel and prednisone, a steroid drug, is approved by the FDA for treatment of androgen-independent prostate cancer.

This trial is evaluating the addition of two targeted therapies, bevacizumab and thalidomide, to chemotherapy with docetaxel and prednisone. Bevacizumab and thalidomide both interfere with the formation of new blood vessels in tumors, which is required for tumor growth and survival. These targeted therapies inhibit different cell-signaling pathways used by tumors to make new blood vessels and should, therefore, be more effective when given together than when either is given alone.

The preliminary results of this trial have been promising. "Of the 26 patients we've enrolled so far, only one patient has come off the trial for progression of disease," said Dr. Dahut. "The trial has been open for about a year, and the median survival of these patients with androgen-independent prostate cancer is about 15 months. That patients are still responding after a year is encouraging."

Who Can Join This Trial
Researchers seek to enroll 33 to 60 patients aged 18 or over who have metastatic prostate cancer that has progressed despite hormone-suppressing therapy. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/NCI-04-C-0257.

Study Site and Contact Information
The study is taking place at the NIH Clinical Center in Bethesda, Md. For more information, call the NCI Clinical Studies Support Center at 1-888-NCI-1937. The toll-free call is completely confidential.