Colorectal CancerPhase 4NCT00559676
Study of Biomarkers in Patients Undergoing Chemotherapy for Metastatic Colorectal Cancer
A Phase 4 study testing capecitabine, fluorouracil and irinotecan hydrochloride in people with Colorectal Cancer, run by Centre Hospital Regional Universitaire de Limoges at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- capecitabine, fluorouracil and irinotecan hydrochloride
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2005to May 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 4 Study to Characterize and Evaluate Markers of Chemoresistance in Patients With Metastatic Colorectal Cancer
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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- capecitabine, fluorouracil, irinotecan hydrochloride, leucovorin calcium, oxaliplatin
- Keywords
- recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabineDrug
fluorouracilDrug
oxaliplatinDrug
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Oncogenetic parameters
Pharmacogenetic and pharmacokinetic predictors of therapeutic response and toxic effects
Secondary outcomes (2)
Correlations between the pharmacogenetic and pharmacokinetic parameters
Predictive value of pharmacogenetic and pharmacokinetic parameters on disease-free and overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study startMar 2005
- Primary completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospital Regional Universitaire de Limoges
- Sponsor type
- University, hospital or other
- Investigators
- Nicole Tubiana-Mathieu, MD, Study chair, Centre Hospital Regional Universitaire de Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559676
- Sponsor's protocol ID
- CDR0000574159
- Other IDs
- CHUL-BIO-COLON, INCA-RECF0356
- Status last verified
- Jul 2009
- First submitted
- 15 Nov 2007
- Last updated
- 16 May 2011
- Results posted
- No
Publications
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.
PubMed 33912999
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study to Characterize and Evaluate Markers of Chemoresistance in Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00559676
- Acronym / sponsor ID
- CDR0000574159
- Conditions
- Colorectal Cancer
- Keywords
- recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospital Regional Universitaire de LimogesUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- May 2011 (actual)
- First posted
- 16 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| capecitabine | Drug | – |
| fluorouracil | Drug | – |
| irinotecan hydrochloride | Drug | – |
| leucovorin calcium | Drug | – |
| oxaliplatin | Drug | – |
| laboratory biomarker analysis | Other | – |
| pharmacological study | Other | – |
Primary outcome
Oncogenetic parameters
Pharmacogenetic and pharmacokinetic predictors of therapeutic response and toxic effects
2 secondary outcomes
Correlations between the pharmacogenetic and pharmacokinetic parameters
Predictive value of pharmacogenetic and pharmacokinetic parameters on disease-free and overall survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2011.
- Derived from this study: PubMed 33912999Deyme 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Tubiana-Mathieu, MD study chair
Centre Hospital Regional Universitaire de Limoges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing capecitabine, fluorouracil and irinotecan hydrochloride in people with Colorectal Cancer, run by Centre Hospital Regional Universitaire de Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oncogenetic parameters. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00559676, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2011.