Biomarkers in Predicting Neurotoxicity in Patients With Colorectal Cancer Receiving Oxaliplatin

Sponsor

Institut Cancerologie de l'Ouest (Other)

Overall Status

Unknown status

CT.gov ID

NCT00884767

Collaborator

(none)

206

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chemotherapeutic Agent Toxicity Colorectal Cancer Neurotoxicity	Drug: FOLFOX regimen Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Genetic: gene expression analysis Genetic: protein expression analysis Genetic: proteomic profiling Other: laboratory biomarker analysis Other: pharmacogenomic studies	Phase 2

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.

OUTLINE: This is a multicenter study.

Patients receive oxaliplatin every 2 weeks as part of a FOLFOX chemotherapy regimen.

Blood samples are collected 15 days prior to beginning chemotherapy, prior to each course of chemotherapy, and at 1 month after completion of chemotherapy for pharmacogenetic and laboratory biological studies. Patients with chronic neurotoxicity undergo additional blood sample collection at 3, 6, 9, and 12 months after completion of chemotherapy. Samples are analyzed for the detection of gene variants involved in the oxalate and fluorouracil metabolic pathway; neurotrophic factors; proteomic analysis of plasma proteins and peptides; and for biological testing of neurotoxicity.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

206 participants

Allocation:

Non-Randomized

Primary Purpose:

Treatment

Official Title:

Characterization and Research of Predictive Markers of Neurotoxicity During Treatment With Oxaliplatin in Colorectal Carcinoma: a Genetic and Proteomic Approach. Phase II Multicenter Study

Study Start Date :

Sep 1, 2007

Anticipated Primary Completion Date :

Aug 1, 2009

Outcome Measures

Primary Outcome Measures

Correlation of genetic profiles and peptide, protein, and neurotrophic factors with neurological toxicity []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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