Biomarkers in Predicting Neurotoxicity in Patients With Colorectal Cancer Receiving Oxaliplatin
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
ICO Paul Papin
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00884767
First received: April 18, 2009
Last updated: July 7, 2009
Last verified: July 2009
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Purpose
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 | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Correlation of genetic profiles and peptide, protein, and neurotrophic factors with neurological toxicity [ Designated as safety issue: No ]
| Estimated Enrollment: | 206 |
| Study Start Date: | September 2007 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00884767
Locations
| France | |
| Centre Paul Papin | Recruiting |
| Angers, France, 49036 | |
| Contact: Erick Gamelin, MD 33-2-4135-2700 e.gamelin@unimedia.fr | |
Sponsors and Collaborators
ICO Paul Papin
Investigators
| Principal Investigator: | Erick Gamelin, MD | ICO Paul Papin |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00884767 History of Changes |
| Other Study ID Numbers: | CDR0000633477, CPP-NEUROTOXALI, CPP-CPP340, INCA-RECF0453, EUDRACT-2007-001287-75 |
| Study First Received: | April 18, 2009 |
| Last Updated: | July 7, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
neurotoxicity chemotherapeutic agent toxicity recurrent colon cancer stage I colon cancer stage II colon cancer stage III colon cancer |
stage IV colon cancer recurrent rectal cancer stage I rectal cancer stage II rectal cancer stage III rectal cancer stage IV rectal cancer |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Neurotoxicity Syndromes Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Nervous System Diseases Poisoning Substance-Related Disorders |
Fluorouracil Oxaliplatin Leucovorin Levoleucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Vitamin B Complex Vitamins |
ClinicalTrials.gov processed this record on May 19, 2013