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

GERCOR - Multidisciplinary Oncology Cooperative Group58 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cancer

Interventions

oxaliplatinDRUG

management of therapy complicationsPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

CHU de Grenoble - Hopital Michallon

Grenoble, France

RECRUITING

Centre Hospital Universitaire Hop Huriez

Lille, France

RECRUITING

Clinique Saint Jean

Lyon, France

Outcomes

Primary Outcomes

Relationship between residual platinum levels in the blood and persistent neurotoxicity

Secondary Outcomes

Pharmacokinetics

Data from ClinicalTrials.gov

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