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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00274885
• Other study ID #: CDR0000454401
• Secondary ID: GERCOR-TAUROXSAN
• Status: Recruiting
• Phase: Phase 4
• First received: January 10, 2006
• Last updated: December 2, 2011
• Start date: October 2005

Study information

• Verified date: May 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

RATIONALE: 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.

PURPOSE: 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.

Description:

OBJECTIVES:

Primary

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

Secondary

• Determine the pharmacokinetics of oxaliplatin in these patients.

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No other concurrent drug or agent that is potentially neurotoxic

Study Design

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Gastrointestinal Neoplasms
• Neurotoxicity Syndromes

Intervention

Drug:
• oxaliplatin

Procedure:
• management of therapy complications

Locations

Country	Name	City	State
France	CHU de Grenoble - Hopital Michallon	Grenoble
France	Centre Hospital Universitaire Hop Huriez	Lille
France	Clinique Saint Jean	Lyon
France	CHU Pitie-Salpetriere	Paris
France	Hopital Saint Antoine	Paris
France	Hopital Tenon	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship between residual platinum levels in the blood and persistent neurotoxicity			Yes
Secondary	Pharmacokinetics			No