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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 the Relationship Between Residual Platinum Levels in the Blood and Persistent Neurotoxicity in Patients Who Are Receiving Oxaliplatin for Gastrointestinal Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase IV Supportive care, Treatment Active 18 and over Other, Pharmaceutical / Industry GERCOR-TAUROX SANOFI-GERCOR-TAUROX, EU-20573, NCT00274885

Trial Description

Purpose:

Learning about the relationship between platinum levels in the blood and neurotoxicity in patients receiving oxaliplatin may help plan treatment and may help patients live more comfortably.

This phase IV trial is studying the relationship between platinum levels in the blood and neurotoxicity in patients who are receiving oxaliplatin for gastrointestinal cancer.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Receiving or planning to receive a chemotherapy regimen that includes oxaliplatin for 8 months
• No signs of nerve damage, such as numbness or tingling, being sensitive to cold, or trouble breathing, swallowing, or talking
• No CNS cancer
• 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 a 2-hour infusion of oxaliplatin. Treatment may repeat every 2-3 weeks for as long as benefit is shown.

Patients will also undergo neurological exams and blood collection before beginning treatment, after each course of oxaliplatin, and after finishing treatment.

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

GERCOR Groupe Cooperateur Multidisciplinaire en Oncologie

Philippe Lechat, Protocol chair		Ph: 33-1-4216-0000

France
	Grenoble
	CHU de Grenoble - Hopital Michallon
		Christine Rebischung	Ph:  33-4-7676-5451
	Lille
	Centre Hospital Universitaire Hop Huriez
		Mohamed Hebbar, MD	Ph:  33-3-2044-5461
			Email: m-hebbar@chru-lille.fr
	Lyon
	Clinique Saint Jean
		Gerard Lledo	Ph:  33-4-7878-1051
	Paris
	CHU Pitie-Salpetriere
		Jean-Baptiste Meric, MD	Ph:  33-1-4216-0471
			Email: jeanbaptiste.meric@psl.ap-hop-paris.fr
	Hopital Saint Antoine
		Olivier Rosmorduc, MD, PhD	Ph:  33-1-4928-2382
			Email: olivier.rosmorduc@sat.aphp.fr
	Hopital Tenon
		Thierry Andre, MD	Ph:  33-1-6177-0708
			Email: thierry.andre@tnn.ap-hop-paris.fr

Registry Information
Official Title		Study of the Relationship Between the Rate of Residual Platinum in the Blood and the Incidence of Persistent Neurotoxicity in Patients Treated for Gastrointestinal Cancer With Oxaliplatin
Trial Start Date		2005-10-10
Registered in ClinicalTrials.gov		NCT00274885
Date Submitted to PDQ		2005-09-14
Information Last Verified		2007-05-08