Docetaxel and Sirolimus in Patients With Advanced Malignancies
The goal of this clinical research study to find the highest tolerated dose of the combination of Taxotere (docetaxel) and Rapamycin (sirolimus) when given to patients with advanced cancer.
Researchers also want to find highest tolerated dose of the combination of docetaxel, sirolimus, and prednisone when given to patients with advanced prostate cancer. The safety of both drug combinations will also be studied.
|Advanced Cancer||Drug: Docetaxel (Taxotere) Drug: Sirolimus (Rapamycin) Drug: Prednisone||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Trial of Docetaxel and Sirolimus in Patients With Advanced Malignancies|
- Maximum Tolerated Dose(MTDs) for Docetaxel - Sirolimus [ Time Frame: Every week for first 3 weeks then every 3 weeks ]
|Study Start Date:||January 2010|
|Study Completion Date:||October 2014|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Experimental: Docetaxel + Sirolimus
Starting doses of Docetaxel 30 mg/m^2 IV every 3 weeks + Sirolimus 1 mg daily
Drug: Docetaxel (Taxotere)
Starting dose 30 mg/m^2 by vein (IV) over about 1 hour on Day 1 of every 21 day cycle.Drug: Sirolimus (Rapamycin)
Starting dose 1 mg daily by mouth 1 time a day.
Other Name: RapamuneDrug: Prednisone
5 mg by mouth twice a day with prostate cancer.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01054313
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Filip Janku, MD, PHD||M.D. Anderson Cancer Center|