Study of Biomarkers in Patients Undergoing Chemotherapy for Metastatic Colorectal Cancer
This study has been completed.
Sponsor:
Centre Hospital Regional Universitaire de Limoges
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00559676
First received: November 15, 2007
Last updated: May 13, 2011
Last verified: July 2009
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Purpose
RATIONALE: Studying samples of blood and tumor tissue in the laboratory from patients with cancer receiving chemotherapy may help doctors understand the effect of chemotherapy on biomarkers. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This phase IV trial is studying biomarkers in patients undergoing chemotherapy for metastatic colorectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: capecitabine Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Drug: oxaliplatin Other: laboratory biomarker analysis Other: pharmacological study |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Primary Purpose: Treatment |
| Official Title: | Phase 4 Study to Characterize and Evaluate Markers of Chemoresistance in Patients With Metastatic Colorectal Cancer |
Resource links provided by NLM:
Drug Information available for:
Fluorouracil
Leucovorin calcium
Oxaliplatin
Levoleucovorin
Irinotecan
Irinotecan hydrochloride
Capecitabine
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Oncogenetic parameters [ Designated as safety issue: No ]
- Pharmacogenetic and pharmacokinetic predictors of therapeutic response and toxic effects [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Correlations between the pharmacogenetic and pharmacokinetic parameters [ Designated as safety issue: No ]
- Predictive value of pharmacogenetic and pharmacokinetic parameters on disease-free and overall survival [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | March 2005 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- Research the oncogenetic parameters and pharmacogenetic and pharmacokinetic predictors of therapeutic response and toxic effects.
Secondary
- Study the correlations between the pharmacogenetic and pharmacokinetic parameters.
- Study the predictive value of these parameters on disease-free and overall survival.
OUTLINE: This is a multicenter study.
Patients receive 1 of 4 chemotherapy regimens:
- Regimen 1: Fluorouracil and leucovorin calcium
- Regimen 2: Capecitabine and leucovorin calcium
- Regimen 3: Irinotecan hydrochloride
- Regimen 4: Oxaliplatin Tumor and blood samples are collected before the start of chemotherapy and are examined by pharmacogenetic analysis. Clinical and biological parameters are also studied. Blood samples are also collected during the first course of chemotherapy for pharmacokinetic studies.
After completion of study therapy, patients are followed periodically for 3 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic colorectal cancer
- Unresectable metastatic disease must be confirmed histologically if > 2 years since primary diagnosis
- Measurable metastatic disease > 1 cm by spiral CT scan or > 2 cm by other methods
Scheduled to receive first-line chemotherapy for metastatic disease
- Chemotherapy must include fluorouracil, capecitabine, irinotecan hydrochloride, or oxaliplatin
- No inadequate or unusable tissue as the only tissue available
- No known brain metastases or meningeal disease
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- No contraindication to chemotherapy
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other severe pathology that is likely to worsen during therapy
- No dementia or severely impaired mental condition
- No geographical or psychological reasons that would preclude treatment
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior therapy for metastatic cancer
- Prior adjuvant chemotherapy allowed
- Concurrent bevacizumab or other monoclonal antibody therapy allowed
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00559676
Locations
| France | |
| Centre Hospital Regional Universitaire de Limoges | |
| Limoges, France, 87042 | |
Sponsors and Collaborators
Centre Hospital Regional Universitaire de Limoges
Investigators
| Study Chair: | Nicole Tubiana-Mathieu, MD | Centre Hospital Regional Universitaire de Limoges |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00559676 History of Changes |
| Other Study ID Numbers: | CDR0000574159, CHUL-BIO-COLON, INCA-RECF0356 |
| Study First Received: | November 15, 2007 |
| Last Updated: | May 13, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent colon cancer stage IV colon cancer recurrent rectal cancer stage IV rectal cancer |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Fluorouracil Capecitabine Oxaliplatin Irinotecan |
Camptothecin 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 Micronutrients |
ClinicalTrials.gov processed this record on May 19, 2013