Genes as Predictors of Response to Gemcitabine, Docetaxel, and Capecitabine (GTX) in Metastatic or Unresectable Pancreatic Cancer.
This is a study for patients with advanced pancreatic cancer, using the drugs gemcitabine, docetaxel and capecitabine. Gemcitabine is a drug that has been approved by the FDA. Gemcitabine is been approved for treatment of cancer of the pancreas. It is also approved for treatment of lung cancer in combination with another drug called cisplatin. Docetaxel is a drug approved by the FDA. Docetaxel is approved for treatment of breast and lung cancer. Capecitabine is a drug approved by the FDA for treatment of cancer of the colon and rectum. This study will measure the levels of certain substances in participant's tumors. These substances (called genes, which are the cell's blueprint for these substances) affect how people's bodies react to the cancer drugs. Genes will also be measured in participant's blood. The purpose of this study is to see if these substances can predict survival and response in patients receiving the study drugs. In this study we wish to find out how long it takes for patients' cancers to worsen, and how long they survive after receiving the study drugs. The side effects of the combination of gemcitabine, docetaxel and capecitabine will also be evaluated.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Trial of Germline Polymorphisms as Predictors of Response to Gemcitabine, Docetaxel, and Capecitabine (GTX) in Metastatic or Unresectable Pancreatic Cancer.|
- To see if patients with advanced pancreatic cancer treated with gemcitabine, docetaxel and capecitabine who bear more favorable genotypes of genes involved in drug metabolisms are more likely to have response and survive longer than those that do not.
- To assess time to progression, toxicity and to identify other molecular correlates of response, toxicity, and survival.
|Study Start Date:||February 2005|
|Study Completion Date:||July 2006|
|Primary Completion Date:||June 2006 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00159471
|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|