drugset / Trial / NCT01050985

A Study of Temsirolimus Plus Capecitabine in Patients With Advanced Cancer

NCT01050985

Non-randomizedSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2010-07
Primary completion
2013-03
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Capecitabine Small molecule 1750 mg/m2 Oral
Subject Temsirolimus Small molecule 15 mg Intravenous
Subject Temsirolimus Small molecule 25 mg Intravenous

Indications