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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Active 18 and over NCI VU-VICC-GI-0622 VICC-GI-0622, 6980, NCI-6980, NCT00397384

Special Category: SPORE trial

Trial Description

Purpose:

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:

Eligibility criteria include the following:

• At least 18 years old
• At least 4 weeks since biological therapy, chemotherapy, or radiation therapy
• At least 3 weeks since surgery
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

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 Contact Information

Trial Lead Organizations

Vanderbilt-Ingram Cancer Center

Mace Rothenberg, MD, FACP, Protocol chair		Ph: 800-811-8480 Email: mace.rothenberg@vanderbilt.edu

U.S.A.
Tennessee
	Nashville
	Vanderbilt-Ingram Cancer Center
		Clinical Trials Office - Vanderbilt-Ingram Cancer Center	Ph:  1-800-811-8480;
	Vanderbilt-Ingram Cancer Center - Cool Springs
		Mace Rothenberg	Ph:  615-343-8210
	Vanderbilt-Ingram Cancer Center at Franklin
		Mace Rothenberg	Ph:  615-343-8210

Registry Information
Official Title		A Phase I/II Clinical and Biological Evaluation of Combined EGFR Blockade with Erlotinib and Cetuximab in Patients with Advanced Cancer (Phase I) or Advanced Colorectal Cancer (Phase II)
Trial Start Date		2006-12-03
Trial Completion Date		2007-10-29 (estimated)
Registered in ClinicalTrials.gov		NCT00397384
Date Submitted to PDQ		2006-09-25
Information Last Verified		2008-10-01
NCI Grant/Contract Number		CA99177, CA68485, CA95103