| General information |
| Database: | DB00905 |
| Objective: | To determine the maximum tolerated dose (MTD) and safety, and explore efficacy and biomarkers of vandetanib with cetuximab and irinotecan in secondline metastatic colorectal cancer. |
| Authors: | Wadlow RC, et al |
| Title: | Panitumumab in patients with KRAS wildtype colorectal cancer after progression on cetuximab. |
| Journal: | Oncologist. |
| Year: | 2012 |
| PMID: | 22210091 |
| Trial Design |
| Clinical Trial Id: | NCT00842257 |
| Agent: | panitumumab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | colorectal cancer |
| Cancer Subtype: | advanced colorectal cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a singlearmphase II trial |
| Key Patients Feature: | patients with KRAS wildtype colorectal cancer after progression on cetuximab |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | a twostage study design to treat patients with panitumumab at 6 mg/kg every 14 days (cycle length = 28 days). Treatment was continued until disease progression, death, inability to tolerate panitumumab, or study withdrawal. |
| Primary End Point: | response rate; |
| Secondary End Point: | progression free survival and overall survival. |
| Patients Number: | 27 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | 45% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 1.7 months |
| Median OS A vs. C: | 5.2 months |
| Adverse Event(agent arm): | Thirteen patients (65%) had grade 1-2 dry skin or rash, and three patients had treatmentrelated grade 3 toxicities (one each with hyperglycemia, hyperbilirubinemia, and hypokalemia). |
| Conclusions: | Vandetanib can be safely combined with cetuximab and irinotecan for metastatic colorectal cancer. Exploratory biomarker analyses suggest differential effects on certain plasma biomarkers for VEGFR inhibition when combined with EGFR blockade and a potential correlation bettheyen baseline sVEGFR1 and response. Hotheyver, while the primary endpoint was safety, the observed efficacy raises concern for moving forward with this combination. |