Docetaxel and Sirolimus in Patients With Advanced Malignancies
|ClinicalTrials.gov Identifier: NCT01054313|
Recruitment Status : Completed
First Posted : January 22, 2010
Last Update Posted : October 7, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancer||Drug: Docetaxel (Taxotere) Drug: Sirolimus (Rapamycin) Drug: Prednisone||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||103 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of Docetaxel and Sirolimus in Patients With Advanced Malignancies|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
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: Rapamune
5 mg by mouth twice a day with prostate cancer.
- Maximum Tolerated Dose(MTDs) for Docetaxel - Sirolimus [ Time Frame: Every week for first 3 weeks then every 3 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|