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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, Oxaliplatin, Leucovorin Calcium, and Fluorouracil in Patients With Metastatic Colorectal Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Completed	18 and over	NCI	MSKCC-02039 NCI-5371, 5371, NCT00049101

Trial Description

Purpose:

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining erlotinib with combination chemotherapy may kill more tumor cells.

Phase I/II trial to study the effectiveness of combining erlotinib with oxaliplatin, leucovorin, and fluorouracil in treating patients who have metastatic colorectal cancer.

Eligibility:

• At least 18 years old
• No brain metastases
• More than 4 weeks since chemotherapy or radiation therapy
• More than 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 erlotinib alone by mouth during week 1 of the first course of treatment. They will then continue to receive erlotinib by mouth once a day and will also receive a 2-hour infusion of oxaliplatin on day 1, and a 2-hour infusion of leucovorin and a 22-hour continuous infusion of fluorouracil on days 1 and 2. Treatment may be repeated every 2 weeks for at least six courses. Patients will be evaluated periodically for at least 6 months.

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

Leonard Saltz, MD, Protocol chair		Ph: 212-639-2501; 800-525-2225

Registry Information
Official Title		A Phase I/II Study Of OSI-774 In Combination With Oxaliplatin, And 5-Fluourouracil In Patients With Metastatic Colorectal Carcinoma
Trial Start Date		2002-08-26
Registered in ClinicalTrials.gov		NCT00049101
Date Submitted to PDQ		2002-09-05
Information Last Verified		2004-04-15
NCI Grant/Contract Number		P30-CA08748

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