Study of Biomarkers in Patients Undergoing Chemotherapy for Metastatic Colorectal Cancer
NCT ID: NCT00559676
Last Updated: 2011-05-16
Study Results
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Basic Information
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COMPLETED
PHASE4
200 participants
INTERVENTIONAL
2005-03-31
Brief Summary
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PURPOSE: This phase IV trial is studying biomarkers in patients undergoing chemotherapy for metastatic colorectal cancer.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
TREATMENT
Interventions
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capecitabine
fluorouracil
irinotecan hydrochloride
leucovorin calcium
oxaliplatin
laboratory biomarker analysis
pharmacological study
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Centre Hospital Regional Universitaire de Limoges
OTHER
Principal Investigators
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Nicole Tubiana-Mathieu, MD
Role: STUDY_CHAIR
Centre Hospital Regional Universitaire de Limoges
Locations
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Centre Hospital Regional Universitaire de Limoges
Limoges, , France
Countries
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References
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Deyme L, Barbolosi D, Mbatchi LC, Tubiana-Mathieu N, Ychou M, Evrard A, Gattacceca F. Population pharmacokinetic model of irinotecan and its four main metabolites in patients treated with FOLFIRI or FOLFIRINOX regimen. Cancer Chemother Pharmacol. 2021 Aug;88(2):247-258. doi: 10.1007/s00280-021-04255-9. Epub 2021 Apr 28.
Other Identifiers
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CHUL-BIO-COLON
Identifier Type: -
Identifier Source: secondary_id
INCA-RECF0356
Identifier Type: -
Identifier Source: secondary_id
CDR0000574159
Identifier Type: -
Identifier Source: org_study_id
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