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

Alternate Title

Phase II Study of Neoadjuvant Erlotinib Hydrochloride in Patients With Resectable Intraductal Pancreatic Mucinous Neoplasm

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Biomarker/Laboratory analysis, Treatment	Active	18 and over	NCI	UCIRVINE-UCI05-5-01 UCI05-5-01, NCT00482625

Trial Description

Purpose:

Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving erlotinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Studying the proteins expressed in samples of tumor tissue in the laboratory from patients with pancreatic cancer may help doctors identify and learn more about biomarkers related to cancer.

This phase II trial is looking at the effect of erlotinib on protein expression in patients with pancreatic cancer that can be removed by surgery.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Planning to undergo surgery to remove the tumor
• More than 3 weeks since eye surgery
• No hospitalization for mania or bipolar disease within the past 5 years
• 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 erlotinib by mouth once a day for up to 6 weeks. They will then undergo surgery to remove the tumor.

Patients will undergo biopsies and collection of blood samples at the beginning of the study and after finishing treatment with erlotinib for laboratory studies.

After surgery, patients will be evaluated at 4-8 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

Frank Meyskens, MD, FACP, Principal investigator		Ph: 714-456-6310 Email: flmeyske@uci.edu

U.S.A.
California
	Orange
	Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
		Frank Meyskens, MD, FACP	Ph:  714-456-6310
			Email: flmeyske@uci.edu

See All Trial Sites

Registry Information
Official Title		Phase IIA Trial Testing Erlotinib as an Intervention Against Intraductal Pancreatic Mucinous Neoplasms
Trial Start Date		2006-05-01
Registered in ClinicalTrials.gov		NCT00482625
Date Submitted to PDQ		2007-05-04
Information Last Verified		2008-11-30
NCI Grant/Contract Number		CA62203