Clinical trial · Interventional
Cetuximab and Combination Chemotherapy in Treating Patients With Advanced or Metastatic Colorectal Cancer
Phase 2 Study to Improve Tolerance of Chemotherapy Involving Cetuximab and Multidrug FOLFIRI, With Pharmacokinetic and Pharmacogenetic Studies, in Patients With Metastatic Colorectal Cancer
- 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: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with combination chemotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cetuximab together with combination chemotherapy works in treating patients with advanced or 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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cetuximab | Biological | Cetuximab | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Improvement of hematologic and gastrointestinal tolerance to therapy
Secondary outcomes (3)
- measure
- Efficacy
- measure
- Genetic and genomic tumor parameters that could interfere with and predict the toxicity and/or antitumor efficacy of therapy
- measure
- Time to progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed colorectal cancer * Advanced or metastatic disease * Scheduled to receive first- or second-line therapy for metastatic disease * No cerebral metastases or symptomatic or uncontrolled meningeal disease PATIENT CHARACTERISTICS: * WHO performance status 0-2 * ANC ≥ 2,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Total bilirubin ≤ 2 times upper limit of normal (ULN) * AST and ALT ≤ 3 times ULN * Alkaline phosphatase ≤ 5 times ULN * Not pregnant or nursing * Fertile patients must use effective contraception * No intestinal blockage * No complete dihydropyrimidine dehydrogenase deficiency * No chronic inflammatory disease of the colon * No other cancer except for nonmelanoma skin cancer or curatively treated carcinoma of the cervix or breast * No other severe condition, or condition that is likely to worsen, including any of the following: * Unstable heart disease * Myocardial infarction within the past 6 months * Active uncontrolled infection * No contraindication to atropine PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from prior anticancer therapy * More than 4 weeks since prior and no other concurrent investigational therapy * Prior adjuvant chemotherapy allowed * No prior fluorouracil or irinotecan hydrochloride * No other concurrent anticancer therapy
References
Publications (3)
- RESULTRouits E, Charasson V, Petain A, Boisdron-Celle M, Delord JP, Fonck M, Laurand A, Poirier AL, Morel A, Chatelut E, Robert J, Gamelin E. Pharmacokinetic and pharmacogenetic determinants of the activity and toxicity of irinotecan in metastatic colorectal cancer patients. Br J Cancer. 2008 Oct 21;99(8):1239-45. doi: 10.1038/sj.bjc.6604673. Epub 2008 Sep 16. PMID 18797458
- DERIVEDLobet S, Paintaud G, Azzopardi N, Passot C, Caulet M, Chautard R, Desvignes C, Capitain O, Tougeron D, Lecomte T, Ternant D. Relationship Between Cetuximab Target-Mediated Pharmacokinetics and Progression-Free Survival in Metastatic Colorectal Cancer Patients. Clin Pharmacokinet. 2023 Sep;62(9):1263-1274. doi: 10.1007/s40262-023-01270-2. Epub 2023 Jul 13. PMID 37442917
- DERIVEDRollin J, Payance A, Gouilleux-Gruart V, Boisdron-Celle M, Azzopardi N, Morel A, Gruel Y, Paintaud G, Gamelin E, Watier H, Lecomte T. Significant effect of VEGFA polymorphisms on the clinical outcome of metastatic colorectal cancer patients treated with FOLFIRI-cetuximab. Pharmacogenomics. 2015 Dec;16(18):2035-43. doi: 10.2217/pgs.15.139. Epub 2015 Nov 30. PMID 26615857