Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Relationship Between Platinum Levels in the Blood and 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

Objectives

Primary

1. Determine the relationship between residual platinum levels in the blood and persistent neurotoxicity in patients receiving oxaliplatin for gastrointestinal cancer.

Secondary

1. Determine the pharmacokinetics of oxaliplatin in these patients.

Entry Criteria

Disease Characteristics:

• Diagnosis of gastrointestinal cancer



• Receiving or planning to receive 8 months of oxaliplatin-based chemotherapy



• No pre-existing neuropathy



• No CNS disease or cerebral metastases

Prior/Concurrent Therapy:

• See Disease Characteristics
• No other concurrent drug or agent that is potentially neurotoxic

Patient Characteristics:

• WHO 0-1
• Life expectancy ≥ 12 weeks
• No biliary or gastro-duodenal obstruction
• No familial, social, geographical, or psychological condition that would preclude study treatment

Expected Enrollment

A total of 58 patients will be accrued for this study.

Outcomes

Relationship between residual platinum levels in the blood and persistent neurotoxicity

Pharmacokinetics

Outline

This is an open-label, nonrandomized, multicenter study.

Patients receive oxaliplatin IV over 2 hours. Treatment repeats every 2-3 weeks in the absence of disease progression or unacceptable toxicity.

Neurological function and platinum levels in the blood are assessed at baseline, after each course of oxaliplatin, and at the end of study treatment.

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