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

GERCOR - Multidisciplinary Oncology Cooperative Group

Status and phase: Unknown; Phase 4

Conditions: Cancer

Treatments: Drug: oxaliplatin; Procedure: management of therapy complications

Study type: Interventional

Funder types: Other

Identifiers

NCT00274885

EU-20573

CDR0000454401

GERCOR-TAUROX

SANOFI-GERCOR-TAUROX

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

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