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Alternate Title Phase I/II Study of Erlotinib Hydrochloride and Cetuximab in Patients With Advanced Gastrointestinal, Head and Neck, Non-Small Cell Lung, or Colorectal Cancer
Special Category: SPORE trial Trial Description Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Erlotinib and cetuximab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving erlotinib together with cetuximab may kill more tumor cells. This phase I/II trial is studying the side effects and best dose of erlotinib when given together with cetuximab and to see how well they work in treating patients with advanced gastrointestinal cancer, head and neck cancer, non-small cell lung cancer, or colorectal cancer. Eligibility criteria include the following:
Final eligibility for a clinical trial is determined by the health professionals conducting the trial. Patients will receive a 1- to 2-hour infusion of cetuximab once a week beginning in week 1 and erlotinib by mouth once a day beginning in week 2. Treatment may continue for as long as benefit is shown. After finishing treatment, patients will be evaluated for 4 weeks. Important: For more details about this trial, refer to the Health Professional version of the trial summary. If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site. Trial Lead Organizations Vanderbilt-Ingram Cancer Center
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