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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 Randomized Study of Erlotinib Hydrochloride in Inhibiting Epidermal Growth Factor Receptor Signaling in Aberrant Crypt Foci in Patients With Curatively Treated Stage I-III Colorectal Cancer or Adenoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Biomarker/Laboratory analysis, Treatment	Active	18 and over	NCI	UCIRVINE-UCI06-8-01 UCI06-8-01, NCT00754494

Trial Description

Purpose:

Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Erlotinib may also stop tumors from growing or coming back.

This randomized phase I/II trial is studying the best dose of erlotinib in treating patients with stage I, stage II, or stage III colorectal cancer or adenoma.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Measurable disease
• Has undergone previous treatment
• More than 6 months since chemotherapy for this cancer
• No radiation therapy to the pelvis
• More than 3 weeks since cornea surgery
• More than 6 months since colorectal cancer 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 be randomly assigned (have an equal chance of being placed) to one of three treatment groups.

Patients in group one will receive erlotinib by mouth and a placebo by mouth once a day.

Patients in group two will receive a smaller dose of erlotinib by mouth and a placebo by mouth once a day.

Patients in group three will receive an even smaller dose of erlotinib by mouth and a placebo by mouth once a day.

Patients will undergo a biopsy before and after treatment. They will also undergo blood sample collection for laboratory studies.

After finishing treatment, patients will be evaluated for up to 9 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

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

Timothy Morgan, MD, Principal investigator		Ph: 562-826-5756

U.S.A.
California
	Long Beach
	Veterans Affairs Medical Center - Long Beach
		Timothy Morgan, MD	Ph:  562-826-5756
	Orange
	Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
		Clinical Trials Office - Chao Family Comprehensive Cancer Center	Ph:  877-UC-STUDY
			Email: ucstudy@uci.edu

See All Trial Sites

Registry Information
Official Title		A Phase IIa Randomized, Double-Blind Trial of Erlotinib in Inhibiting EGF Receptor Signaling in Aberrant Crypt Foci of the Colon
Trial Start Date		2008-09-30
Trial Completion Date		2009-07-31 (estimated)
Registered in ClinicalTrials.gov		NCT00754494
Date Submitted to PDQ		2008-09-03
Information Last Verified		2008-11-30
NCI Grant/Contract Number		CN35160