Clinical trial · Interventional
Study of Biomarkers in Patients Undergoing Chemotherapy for Metastatic Colorectal Cancer
Phase 4 Study to Characterize and Evaluate Markers of Chemoresistance in Patients With Metastatic Colorectal Cancer
NCT00559676CI-TRIAL-00004843completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Oncogenetic parameters
- measure
- Pharmacogenetic and pharmacokinetic predictors of therapeutic response and toxic effects
Secondary outcomes (2)
- measure
- Correlations between the pharmacogenetic and pharmacokinetic parameters
- measure
- Predictive value of pharmacogenetic and pharmacokinetic parameters on disease-free and overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDeyme 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 33912999