Biomarkers in Predicting Neurotoxicity in Patients With Colorectal Cancer Receiving Oxaliplatin

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00884767
• Other study ID #: CDR0000633477
• Secondary ID: CPP-NEUROTOXALIC
• Status: Recruiting
• Phase: Phase 2
• First received: April 18, 2009
• Last updated: July 7, 2009
• Start date: September 2007

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 206
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chemotherapeutic Agent Toxicity
• Colorectal Cancer
• Colorectal Neoplasms
• Neurotoxicity
• Neurotoxicity Syndromes

Intervention

Drug:
• FOLFOX regimen

• fluorouracil

• leucovorin calcium

• oxaliplatin

Genetic:
• gene expression analysis

• protein expression analysis

• proteomic profiling

Other:
• laboratory biomarker analysis

• pharmacogenomic studies

Locations

Country	Name	City	State
France	Centre Paul Papin	Angers

Sponsors (1)

Lead Sponsor	Collaborator
ICO Paul Papin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of genetic profiles and peptide, protein, and neurotrophic factors with neurological toxicity			No