drugset / Trial / NCT00559741
Cetuximab and Combination Chemotherapy in Treating Patients With Advanced or Metastatic Colorectal Cancer
Non-randomizedOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2005-10
- Primary completion
- 2011-05
- Completion
- —
Publications
- Results Rouits 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.
- Lobet 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.
- Rollin 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | — | Intravenous |
| Subject | Irinotecan | Small molecule | — | Intravenous |
| Subject | Leucovorin | Small molecule | — | Intravenous |
| Subject | fluorouracil | Small molecule | — | Intravenous |