Back to resultsStudy of Biomarkers in Patients Undergoing Chemotherapy for Metastatic Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
capecitabine
fluorouracil
irinotecan hydrochloride
leucovorin calcium
oxaliplatin
laboratory biomarker analysis
pharmacological study
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer
Eligibility 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
Sites / Locations
- Centre Hospital Regional Universitaire de Limoges
Outcomes
Primary Outcome Measures
Oncogenetic parameters
Pharmacogenetic and pharmacokinetic predictors of therapeutic response and toxic effects
Secondary Outcome Measures
Correlations between the pharmacogenetic and pharmacokinetic parameters
Predictive value of pharmacogenetic and pharmacokinetic parameters on disease-free and overall survival
Full Information
NCT ID
NCT00559676
First Posted
November 15, 2007
Last Updated
May 13, 2011
Sponsor
Centre Hospital Regional Universitaire de Limoges
1. Study Identification
Unique Protocol Identification Number
NCT00559676
Brief Title
Study of Biomarkers in Patients Undergoing Chemotherapy for Metastatic Colorectal Cancer
Official Title
Phase 4 Study to Characterize and Evaluate Markers of Chemoresistance in Patients With Metastatic Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Centre Hospital Regional Universitaire de Limoges
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
pharmacological study
Primary Outcome Measure Information:
Title
Oncogenetic parameters
Title
Pharmacogenetic and pharmacokinetic predictors of therapeutic response and toxic effects
Secondary Outcome Measure Information:
Title
Correlations between the pharmacogenetic and pharmacokinetic parameters
Title
Predictive value of pharmacogenetic and pharmacokinetic parameters on disease-free and overall survival
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Tubiana-Mathieu, MD
Organizational Affiliation
Centre Hospital Regional Universitaire de Limoges
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Hospital Regional Universitaire de Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
33912999
Citation
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.
Results Reference
derived
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Study of Biomarkers in Patients Undergoing Chemotherapy for Metastatic Colorectal Cancer
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