A Study of Temsirolimus Plus Capecitabine in Patients With Advanced Cancer
This study is for people with advanced cancer for which no curative treatment exists.
The purpose of this study is to test the safety and effectiveness of the combination of the drugs Temsirolimus and Capecitabine and see what effects it has on cancer.
Temsirolimus is a drug that is given by vein that targets a protein important for the growth of cancer cells known as mTOR. By inhibiting this protein, Temsirolimus can inhibit cancer cell growth and even lead to their death.
Capecitabine is a more traditional chemotherapy. It is an oral pill that gets converted in the body to the very common chemotherapy known as 5-fluorouracil.
This research is being done because it is not known if the combination of Temsirolimus and Capecitabine will work better than Capecitabine or Temsirolimus alone.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of the mTOR Inhibitor Temsirolimus Plus Capecitabine in Patients With Advanced Malignancies|
- Identification of the recommended Phase II dose of temsirolimus to be used in combination with capecitabine in patients with advanced malignancies [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Evaluation of toxicity of the combination of temsirolimus plus capecitabine in patients with advanced malignancies as determined by adverse events observed and lab values [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- To determine the response by radiology scans to temsirolimus and 5-FU-based therapies in patients with advanced malignancies [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
- Comparison of the response rate in patients whose tumors demonstrate activation of the mTOR pathway versus those that do not [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Experimental: temsirolimus and capecitabine
Treatment with the combination of temsirolimus and capecitabine
Drug: Temsirolimus and capecitabine
temsirolimus in escalating doses starting at 15-mg IV on days 1 and 8 of a 14 day cycle capecitabine in escalating doses starting at 1000 mg/m2 by mouth twice a day on days 1-7 of a 14-day cycle
This is a Phase I study designed to assess the safety and clinical activity of temsirolimus in combination with capecitabine in patients with advanced malignancies. Because the toxicities of capecitabine are well established, and based on a previous clinical trial of temsirolimus and continuous infusion 5-fluorouracil, an alternating dose escalation plan will be employed.
The first stage of the study will be performed to identify the maximally tolerated dose of the combination, when capecitabine is given on a every 2 week schedule. The starting dose of temsirolimus will be 15-mg IV on day 1 and 8 plus capecitabine 1000 mg/m2 by mouth twice a day on days 1-7 of a 14 day schedule. Patients will be enrolled in a standard 3+3 dose escalating fashion to a maximum dose of temsirolimus of 25-mg and a maximum dose of capecitabine of 1750 mg/m2 twice a day.
If the maximally tolerated dose is determined for the every 2 week schedule, then in the second stage of the study a similar dose escalation plan will be employed for an every 3 week schedule.
|United States, District of Columbia|
|Georgetown University Medical Center|
|Washington, District of Columbia, United States, 20057|
|Principal Investigator:||Michael J Pishvaian, Md, PhD||Georgetown University|