NCT00884767UnknownPhase 2
Characterization and Research of Predictive Markers of Neurotoxicity During Treatment With Oxaliplatin in Colorectal Carcinoma: a Genetic and Proteomic Approach. Phase II Multicenter Study
Institut Cancerologie de l'Ouest2 sites in 1 country206 target enrollmentStarted: September 1, 2007Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 206
- Locations
- 2
- Primary Endpoint
- Correlation of genetic profiles and peptide, protein, and neurotrophic factors with neurological toxicity
Study Overview
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 neurotoxicity.
PURPOSE: This phase II trial is studying biomarkers in predicting neurotoxicity in patients with colorectal cancer receiving oxaliplatin.
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 carcinoma.
Secondary
- Differentiate between risk factors predictive of acute and chronic neurotoxicity.
- Establish a possible relationship between acute and chronic neurotoxicity.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- Not provided
Outcomes
Primary Outcomes
Correlation of genetic profiles and peptide, protein, and neurotrophic factors with neurological toxicity
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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