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

Alternate Title

Phase IV Study of Chemoresistance Markers in Patients Undergoing Chemotherapy for Metastatic Colorectal Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase IV Biomarker/Laboratory analysis, Treatment Active 18 and over Other CHUL-BIO-COLON RECF0356, INCA-RECF0356, NCT00559676

Trial Description

Purpose:

Studying samples of blood and tumor tissue in the laboratory from patients with cancer receiving chemotherapy may help doctors understand the effect of chemotherapy on biomarkers. It may also help doctors predict how patients will respond to treatment.

This phase IV trial is studying biomarkers in patients undergoing chemotherapy for metastatic colorectal cancer.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Measurable disease
• Planing to undergo chemotherapy that includes fluorouracil, capecitabine, irinotecan, or oxaliplatin for metastatic cancer
• No brain metastases or meningeal disease
• 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 fluorouracil and leucovorin, capecitabine and leucovorin, irinotecan, or oxaliplatin.

Tumor tissue and blood samples will be collected before beginning chemotherapy for laboratory studies. Blood samples will also be collected during the first course of chemotherapy.

After finishing treatment, patients will be evaluated periodically for 3 years.

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

Centre Hospital Regional Universitaire de Limoges

Nicole Tubiana-Mathieu, MD, Protocol chair		Ph: 33-5-5505-6123 Email: oncologie@chu-limoges.fr

France
	Limoges
	Centre Hospital Regional Universitaire de Limoges
		Nicole Tubiana-Mathieu, MD	Ph:  33-5-5505-6123
			Email: oncologie@chu-limoges.fr

Registry Information
Official Title		Phase 4 Study to Characterize and Evaluate Markers of Chemoresistance in Patients With Metastatic Colorectal Cancer
Trial Start Date		2005-03-10
Registered in ClinicalTrials.gov		NCT00559676
Date Submitted to PDQ		2007-10-18
Information Last Verified		2008-12-28