drugset / Trial / NCT00508404
Panitumumab Plus FOLFIRI in First-line Treatment of Metastatic Colorectal Cancer
NaSingle-groupOpen-labelTreatment
Summary
To estimate the effect of KRAS mutation status (Wild-type versus Mutant) on objective response rate and other measures of efficacy for patients treated with panitumumab in combination with a chemotherapy regimen of irinotecan, 5-fluorouracil, and leucovorin (FOLFIRI) as first-line therapy for metastatic colorectal cancer (mCRC).
Timeline
- Start
- 2007-05-09
- Primary completion
- 2009-06-01
- Completion
- 2012-06-12
Publications
- Background Kohne CH, Hofheinz R, Mineur L, Letocha H, Greil R, Thaler J, Fernebro E, Gamelin E, Decosta L, Karthaus M. First-line panitumumab plus irinotecan/5-fluorouracil/leucovorin treatment in patients with metastatic colorectal cancer. J Cancer Res Clin Oncol. 2012 Jan;138(1):65-72. doi: 10.1007/s00432-011-1061-6. Epub 2011 Sep 30.
- Background Thaler J, Karthaus M, Mineur L, Greil R, Letocha H, Hofheinz R, Fernebro E, Gamelin E, Banos A, Kohne CH. Skin toxicity and quality of life in patients with metastatic colorectal cancer during first-line panitumumab plus FOLFIRI treatment in a single-arm phase II study. BMC Cancer. 2012 Sep 29;12:438. doi: 10.1186/1471-2407-12-438.
- Taieb J, Geissler M, Rivera F, Karthaus M, Wilson R, Loupakis F, Price T, Tracy M, Burdon P, Peeters M. Relationship Between Tumor Response and Tumor-Related Symptoms in RAS Wild-Type Metastatic Colorectal Cancer: Retrospective Analyses From 3 Panitumumab Trials. Clin Colorectal Cancer. 2019 Dec;18(4):245-256.e5. doi: 10.1016/j.clcc.2019.07.009. Epub 2019 Jul 29.
- Kohne CH, Karthaus M, Mineur L, Thaler J, Van den Eynde M, Gallego J, Koukakis R, Berkhout M, Hofheinz RD. Impact of Primary Tumour Location and Early Tumour Shrinkage on Outcomes in Patients with RAS Wild-Type Metastatic Colorectal Cancer Following First-Line FOLFIRI Plus Panitumumab. Drugs R D. 2019 Sep;19(3):267-275. doi: 10.1007/s40268-019-0278-8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Panitumumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Background | Irinotecan | Small molecule | 180 mg/m2 | — |
| Background | Leucovorin | Small molecule | 400 mg/m2 | — |
| Background | fluorouracil | Small molecule | 400 mg/m2 | — |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | — |