Status:
UNKNOWN
Relationship Between Platinum Levels in the Blood and Neurotoxicity in Patients Who Are Receiving Oxaliplatin for Gastrointestinal Cancer
Lead Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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....
Detailed Description
OBJECTIVES: Primary * Determine the relationship between residual platinum levels in the blood and persistent neurotoxicity in patients receiving oxaliplatin for gastrointestinal cancer. Secondary ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00274885
Start Date
October 1 2005
Last Update
December 5 2011
Active Locations (6)
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1
CHU de Grenoble - Hopital Michallon
Grenoble, France, 38043
2
Centre Hospital Universitaire Hop Huriez
Lille, France, 59037
3
Clinique Saint Jean
Lyon, France, 69008
4
Hopital Saint Antoine
Paris, France, 75571