NCT00559676

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for phase_4 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2007

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Last Updated

May 16, 2011

Status Verified

July 1, 2009

Enrollment Period

6.2 years

First QC Date

November 15, 2007

Last Update Submit

May 13, 2011

Conditions

Colorectal Cancer

Keywords

recurrent colon cancerstage IV colon cancerrecurrent rectal cancerstage IV rectal cancer

Outcome Measures

Primary Outcomes (2)

  • 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

Interventions

capecitabineDRUG
fluorouracilDRUG
irinotecan hydrochlorideDRUG
leucovorin calciumDRUG
oxaliplatinDRUG
laboratory biomarker analysisOTHER
pharmacological studyOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Centre Hospital Regional Universitaire de Limoges

Limoges, 87042, France

Location

Related Publications (1)

  • 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.

    PMID: 33912999DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

CapecitabineFluorouracilIrinotecanLeucovorinOxaliplatin

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesCamptothecinAlkaloidsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesCoordination ComplexesOrganic Chemicals

Study Officials

  • Nicole Tubiana-Mathieu, MD

    Centre Hospital Regional Universitaire de Limoges

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 15, 2007

First Posted

November 16, 2007

Study Start

March 1, 2005

Primary Completion

May 1, 2011

Last Updated

May 16, 2011

Record last verified: 2009-07

Locations

FR(1)