Status:
UNKNOWN
Biomarkers in Predicting Neurotoxicity in Patients With Colorectal Cancer Receiving Oxaliplatin
Lead Sponsor:
Institut Cancerologie de l'Ouest
Conditions:
Chemotherapeutic Agent Toxicity
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Studying samples of blood in the laboratory from patients receiving oxaliplatin for cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to neu...
Detailed Description
OBJECTIVES: Primary * Correlate predictive genetic, proteomic, and/or neurotrophic markers with neurological manifestations related to the administration of oxaliplatin in patients with colorectal c...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed colorectal cancer
- Requires treatment with oxaliplatin (as part of a FOLFOX regimen)
- No brain metastases or symptomatic meningitis
- PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Life expectancy \> 3 months
- ANC ≥ 1 x 10\^9/L
- Platelet count ≥ 100 x 10\^9/L
- Total bilirubin ≤ 2 times upper limit of normal (ULN)
- Transaminases ≤ 3 times ULN
- Alkaline phosphatase ≤ 5 times ULN
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No prior or concurrent clinical neuropathy (regardless of the etiology)
- No dihydropyrimidine dehydrogenase deficiency
- No psychiatric illness that would preclude comprehension of the study or of the informed consent
- No other severe illness that may worsen during treatment, including unstable cardiac disease, myocardial infarction within the past 6 months, or active uncontrolled infection
- No psychological, social, familial, or geographical reason that would preclude study follow-up
- Other cancer within the past 5 years allowed provided treatment did not include platinum derivatives or taxanes
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior chemotherapy allowed (except for platinum derivatives or taxanes)
Exclusion
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT00884767
Start Date
September 1 2007
Last Update
July 8 2009
Active Locations (1)
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1
Centre Paul Papin
Angers, France, 49036