Capecitabine and Gemcitabine in Patients With Metastatic Colorectal Cancer
This study is for patients with colorectal cancer that has spread and has increased in size after standard treatments. This study is being done to find out how long it takes their tumors to grow after treatment with the chemotherapy drugs capecitabine and gemcitabine. Capecitabine is a chemotherapy drug that has been approved by the FDA for the treatment of colorectal cancer. We are adding another drug (called gemcitabine), which is approved by the FDA for the treatment of cancer of the pancreas to see if the ability of capecitabine to shrink tumors can be improved by adding gemcitabine. The side effects of the combination will also be evaluated. Another purpose of this study is to measure the levels of certain substances that affect how the body reacts to the chemotherapy agents in cancer cells (in the tumor). In addition, the genes (which are the cell's blueprint for these substances) will also be evaluated in the blood.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Capecitabine and Gemcitabine in Patients With Metastatic Colorectal Cancer|
- To assess time to progression in patients with metastatic colorectal cancer treated with a combination of gemcitabine and capecitabine after progressing on two or more therapies for advanced disease, and having failed both CPT-11 and Oxaliplatin bas
- To assess the response rate and survival in patients with metastatic colorectal cancer treated with a combination of gemcitabine and capecitabine after progressing on two or more therapies for advanced disease. To assess the toxicity of this regimen.
- To assess whether polymorphisms of thegenes involved in the 5-FU metabolic pathway are associated with efficacy of chemotherapy and toxicity.
- To test the hypothesis that increased gene expression levels predict chemoresistance to capecitabine.
|Study Start Date:||March 2004|
|Study Completion Date:||November 2007|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00159445
|United States, California|
|U.S.C./Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Syma Iqbal, M.D.||U.S.C./Norris Comprehensive Cancer Center|