Primary objectives: To determine the maximum tolerated doses (MTDs) of daily lenalidomide and docetaxel given every three weeks and prednisone, as combination therapy to subjects with androgen independent prostate cancer To evaluate the safety profile of the combination of daily lenalidomide and every three week docetaxel and prednisone when given to subjects with androgen independent prostate cancer Secondary objective: To explore the anti-tumor activity of the combination of daily lenalidomide and every 3 week docetaxel and prednisone when given to subjects with androgen independent prostate cancer.
Adenocarcinoma of the prostate is the second leading cause of cancer death in men. There is medication available to help treat this disease, which typically lengthens life by 10 to 12 months. More recent studies have shown average survivals of 20 to 23 months. The investigators hope that the experimental (research) drug called lenalidomide (Revlimid®), which is being used in this study, will lengthen the lives of these patients by even more time. A different drug in the same drug family has demonstrated activity against a variety of solid tumors as well as hematological malignances. It works against cancer in different ways than chemotherapy by affecting the immune system (the body's ability to naturally fight disease). The investigators believe that the study drug helps build up patients' immune systems than some of the other popular drugs on the market, and may potentially increase survival rates for patients with hormone refractory prostate cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Supplied as 5 mg and 25 mg capsules. The lenalidomide dose levels to be studied include 10, 15, 20, 25, 30, 35 and 40 mg/day.
Docetaxel is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Doses of docetaxel to be studied include 60 and 75 mg/m2 once every three weeks.
Prednisone is a synthetic corticosteroid drug that is particularly effective as an immunosuppressant drug. 5 mg BID daily.
Columbia University Medical Center
New York, New York, United States
Cornell Weill Medical Center
New York, New York, United States
Maximum tolerated dose (MTD) of lenalidomide
The MTDs of lenalidomide, docetaxel and prednisone when given as combination therapy will be defined as the highest dose level at which no more than 1 out of 6 subjects experiences Dose Limiting Toxicity (DLT).
Time frame: Up to 2 years
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