Study of Oxaliplatin and Xeloda and Cetuximab as First Line Treatment for Metastatic or Unresectable Gastric or Gastroesophageal Junction Cancer

• Status: Unknown status
• Trial end date: 2019-12-28

Summary

This study is for people with advanced gastric or gastroesophageal cancer. This study is being done to find out how long it takes tumors to grow after patients take the drugs capecitabine, oxaliplatin and cetuximab. Capecitabine (also called Xeloda) is a drug that has been approved by the Food and Drug Administration (FDA). Capecitabine has been approved for treatment of cancer of the colon and rectum. Oxaliplatin is another drug approved by the FDA. Oxaliplatin is also approved for treatment of cancer of the colon and rectum. Cetuximab is also a drug approved by the FDA for the treatment of cancer of the colon and rectum, as well as cancer of the head and neck. Capecitabine, oxaliplatin and cetuximab are not approved for gastric or gastroesophageal cancer. They are considered experimental drugs for this study. The purpose of this study is to see how long it takes patients' tumors to progress when they are taking oxaliplatin and capecitabine. Another purpose is to see how many tumors respond to this drug combination. The investigators also want to see how long people live when taking these drugs. The side effects of this drug combination will also be evaluated. This study will also measure the levels of certain genes (the cell's blueprint) in tumors. These genes affect how peoples' bodies react to the cancer drugs. Genes will also be measured in the blood. The investigators want to see how these genes can predict response to these study drugs.

• Phase: Phase 2

Details

• Lead Sponsor: University of Southern California
• Collaborators: Bristol-Myers Squibb; Roche Global Development; Sanofi
• Treatments: Capecitabine; Cetuximab; Oxaliplatin