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Clinical Trials/NCT00274885
NCT00274885UnknownPhase 4

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

GERCOR - Multidisciplinary Oncology Cooperative Group12 sites in 1 country58 target enrollmentStarted: October 1, 2005Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 4
Sponsor
Enrollment
58
Locations
12
Primary Endpoint
Relationship between residual platinum levels in the blood and persistent neurotoxicity
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

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.

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

  • Determine the pharmacokinetics of oxaliplatin in these patients.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion 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:
  • •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 Criteria

  • Not provided

Outcomes

Primary Outcomes

Relationship between residual platinum levels in the blood and persistent neurotoxicity

Secondary Outcomes

  • Pharmacokinetics

Investigators

Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
Sponsor Class
Other

Study Sites (12)

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