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

Alternate Title

Phase I Study of Erlotinib, Gemcitabine, and Radiotherapy in Patients With Locally Advanced Unresectable Pancreatic Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	MSKCC-03031 NCI-5441, NCT00063947, 5441

Trial Description

Purpose:

Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining erlotinib with gemcitabine may make the tumor cells more sensitive to radiation therapy and may kill more tumor cells.

This phase I trial is studying the side effects and best dose of erlotinib when given together with gemcitabine and radiation therapy in treating patients with locally advanced unresectable pancreatic cancer.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Measurable or evaluable disease
• No brain metastases
• No previous gemcitabine
• No previous therapy for pancreatic cancer other than 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 undergo radiation therapy 5 days a week for 5.5 weeks. At the same time, they will also receive an infusion of gemcitabine twice a week and erlotinib by mouth once a day.

Four to 7 weeks after completing radiation therapy, some patients will receive an infusion of gemcitabine once a week for 2 weeks and erlotinib by mouth once a day. Treatment may be repeated every 3 weeks for up to four courses.

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

Memorial Sloan-Kettering Cancer Center

Eileen O'Reilly, MD, Protocol chair		Ph: 212-639-6672; 800-525-2225 Email: oreillye@mskcc.org

Registry Information
Official Title		A Phase I Study Of OSI-774 In Combination With Gemcitabine And Radiation In Locally Advanced, Non-Operable Pancreatic Cancer
Trial Start Date		2003-06-23
Trial Completion Date		2009-01-27
Registered in ClinicalTrials.gov		NCT00063947
Date Submitted to PDQ		2003-05-13
Information Last Verified		2006-11-16
NCI Grant/Contract Number		CA08748, CA69856

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