Prostate Cancer Clinical Trial
Official title:
Phase I Open-Label, Dose Escalation Study To Determine The Maximum Tolerated Dose And To Evaluate The Safety Profile of Lenalidomide (Revlimid® CC-5013) With Every Three Week Docetaxel (Taxotere®) In Subjects With Androgen Independent Prostate Cancer
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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