Lenalidomide and Paclitaxel in Prostate Cancer
The goal of the Phase I part of this clinical research study is to find the highest tolerable dose of Revlimid® (lenalidomide) that can be given in combination with paclitaxel to patients with prostate cancer who have failed treatment with taxanes.
The goal of the Phase II part of this clinical research study is to learn if lenalidomide and paclitaxel can help to control prostate cancer.
The safety of this combination treatment will be studied in both phases of the study.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Modular Phase I-II Trial of Lenalidomide and Paclitaxel in Men With Castration-Resistant Prostate Cancer and Lymph-Node Dominant Metastases|
- Maximum tolerated dose (MTD) [ Time Frame: Day 1, Days 8 and 15 of each cycle before Paclitaxel, then Day 1 of Cycle 3 and every 2 cycles thereafter ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2009|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Experimental: Lenalidomide and Paclitaxel
Phase I: Up to 5 differing doses of Lenalidomide tested plus fixed dose of Paclitaxel.
Phase II: Lenalidomide at highest tolerated dose from Phase I plus Paclitaxel.
Lead-In beginning dose of 5 mg capsules by mouth once a day for 21 days in a row, followed by 7 days of rest (Days 22-28) for a 28 day cycle.
Other Names:Drug: Paclitaxel
50 mg/m^2 given by vein over 1 hour on Days 1, 8, and 15 of each 28 day cycle.
Other Name: Taxol
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|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Lance Pagliaro, MD||UT MD Anderson Cancer Center|