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Clinical Trial Summary

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.


Clinical Trial Description

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01378091
Study type Interventional
Source Columbia University
Contact
Status Completed
Phase Phase 1
Start date August 2005
Completion date September 2013

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