Protocol Number: 04-C-0132
Men with advanced prostate cancer that does not respond to hormonal therapy may be eligible for this study. Candidates are screened with computed tomography (CT or CAT) scans to determine the extent of cancer and with blood and urine tests to determine if the experimental treatment can be safely given. Participants receive drug therapy in 4-week treatment cycles as follows: - Docetaxel infusions intravenously (through a vein) over a 30-minute period on the second day of the week for 3 consecutive weeks out of every cycle (day 2 of weeks 1, 2, and 3 of each cycle) - Estramustine by mouth in capsule form three times a day for the first 3 days of 3 consecutive weeks in the cycle (days 1, 2, and 3 of weeks 1, 2, and 3 of each cycle) - Thalidomide by mouth in tablet form once a day every day of the study. Additionally, patients take dexamethasone by mouth before and after the docetaxel infusion to prevent fluid retention caused by the drug and the blood thinner enoxaparin once a day. This is injected under the skin to prevent formation of blood clot that may be caused by estramustine and thalidomide. Patients come to the NIH Clinical Center for each docetaxel infusion or they may choose to receive the first weekly dose at the Clinical Center and the second and third infusions at their oncologist's office. In addition to drug therapy, patients have the following tests and procedures: - Periodic blood and urine tests to monitor the response to treatment and drug side effects - Possibly magnetic resonance imaging (MRI) to determine the usefulness of this test in evaluating disease progress and response to treatment - Possibly tumor biopsy (surgical removal of a small piece of tumor tissue) in patients with a tumor mass that is accessible and safe to biopsy. Response to therapy is evaluated approximately every 3 months using various tests, such as bone and CT scans. If there are no severe side effects and the cancer has not progressed, treatment may continue for more than 6 months. After six treatment cycles, patients have monthly chest x-rays to monitor possible fluid collecting around the lining of the lungs, which may occur in some patients who take docetaxel more 6 months or more.
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