Panitumumab Regimen Evaluation in Colorectal Cancer to Estimate Primary Response to Treatment
Summary
The primary objective is to estimate the effect of the human homolog of the Kirsten rat sarcoma-2 virus oncogene (KRAS) mutation status (wild type versus mutant) from tumor tissue on efficacy endpoints in patients with metastatic colorectal cancer (mCRC) receiving second-line chemotherapy with panitumumab after failing first-line treatment.
Timeline
- Start
- 2006-11
- Primary completion
- 2009-01
- Completion
- 2010-10
Outcome
Mixed primary results
registry PRIMARY OUTCOME 7: Overall Survival NCT00411450 ↗
registry analysis (superiority or other test); Wild-type KRAS vs Mutant KRAS; Hazard Ratio (HR) 0.6 (95% CI 0.4 to 0.9) NCT00411450 ↗
registry PRIMARY OUTCOME 1: Objective Response Rate at Weeks 17 and 25 NCT00411450 ↗
registry analysis (superiority or other test); Wild-type KRAS vs Mutant KRAS; Difference 6 (95% CI -11 to 21) NCT00411450 ↗
Publications
- Background Cohn AL, Shumaker GC, Khandelwal P, Smith DA, Neubauer MA, Mehta N, Richards D, Watkins DL, Zhang K, Yassine MR. An open-label, single-arm, phase 2 trial of panitumumab plus FOLFIRI as second-line therapy in patients with metastatic colorectal cancer. Clin Colorectal Cancer. 2011 Sep;10(3):171-7. doi: 10.1016/j.clcc.2011.03.022. Epub 2011 Apr 28.
- Weeraratne D, Chen A, Pennucci JJ, Wu CY, Zhang K, Wright J, Perez-Ruixo JJ, Yang BB, Kaliyaperumal A, Gupta S, Swanson SJ, Chirmule N, Starcevic M. Immunogenicity of panitumumab in combination chemotherapy clinical trials. BMC Clin Pharmacol. 2011 Nov 9;11:17. doi: 10.1186/1472-6904-11-17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Panitumumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Background | Irinotecan | Small molecule | — | — |
| Background | Leucovorin | Small molecule | — | — |
| Background | fluorouracil | Small molecule | — | — |