| General information |
| Database: | DB00936 |
| Objective: | Vascular endothelial growth factor (VEGF) and VEGF receptor 2 (VEGFR2) are believed to mediate angiogenesis in colorectal cancer (CRC). Ramucirumab (RAM; IMC1121B) is a human IgG1 monoclonal antibody that inhibits VEGF ligand binding to VEGFR2, inhibiting VEGFR2 activation and signaling |
| Authors: | GarciaCarbonero R, et al |
| Title: | An openlabelphase II study evaluating the safety and efficacy of ramucirumab combined with mFOLFOX6 as firstline therapy for metastatic colorectal cancer. |
| Journal: | Oncologist. |
| Year: | 2014 |
| PMID: | 24674871 |
| Trial Design |
| Clinical Trial Id: | NCT00862784 |
| Agent: | ramucirumab
|
| Target: | Vascular endothelial growth factor receptor 2
|
| Cancer Type: | colorectal cancer |
| Cancer Subtype: | advanced colorectal cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | ramucirumab combined with mFOLFOX6 |
| Study Type: | An openlabelphase II study |
| Key Patients Feature: | Patients with metastatic CRC, Eastern Cooperative Oncology Group performance status 01, and adequate organ function who had not received chemotherapy for metastatic disease |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts received RAM and the modified FOLFOX6 regimen every 2 weeks |
| Primary End Point: | progression free survival (PFS), objective response rate, overall survival, and safety. |
| Secondary End Point: | NA |
| Patients Number: | 48 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 58.3% (95% CI: 43.2172.39). |
| Disease Control Rate: | 93.8% (95% CI: 82.898.7). |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 11.5 months (95% confidence interval [CI]: 8.613.1 months) |
| Median OS A vs. C: | 20.4 months (95% CI: 18.525.1 months). |
| Adverse Event(agent arm): | The most frequent grade 3-4 adverse events included neutropenia (grade 3: 33.3%; grade 4: 8.3%), hypertension (grade 3: 16.7%), and neuropathy (grade 3: 12.5%). Two patients died during the study due to myocardial infarction and cardiopulmonary arrest. |
| Conclusions: | RAM may enhance the efficacy of modified FOLFOX6 chemotherapy with an acceptable safety profile in metastatic CRC |