| General information |
| Database: | DB00910 |
| Objective: | Targeting the epidermal growth factor receptor and angiogenesis have proven useful strategies against metastatic colorectal cancer. The benefit of combining inhibitors of both pathways is unknown. |
| Authors: | Meyerhardt JA, et al |
| Title: | Phase II study of FOLFOX, bevacizumab and erlotinib as firstline therapy for patients with metastatic colorectal cancer. |
| Journal: | Ann Oncol. |
| Year: | 2007 |
| PMID: | 17483115 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | bevacizumab and erlotinib
|
| Target: | NA
|
| Cancer Type: | colorectal cancer |
| Cancer Subtype: | advanced colorectal cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 13 |
| Therapeutic Combination Content: | FOLFOX+bevacizumab+erlotinib |
| Study Type: | Phase II study |
| Key Patients Feature: | Patients with previously untreated metastatic colorectal cancer were enrolled |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | infusional 5fluorouracil, leucovorin, oxaliplatin (FOLFOX), bevacizumab and erlotinib. |
| Primary End Point: | progression free survival |
| Secondary End Point: | NA |
| Patients Number: | 35 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 34% (95% CI, 18%-50%) |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NR(not reached) |
| Adverse Event(agent arm): | Eightythree percentage of patients experienced treatmentrelated diarrhea (43% were grade 3 or 4). Nearly all patients developed a rash with 26% being classified as grade 3. Other prominent toxic effects included neuropathy, nausea and/or emesis, anorexia, fatigue and bone marrow suppression. No patients experienced an arterial embolic event. Eightysix percentage of patients experienced at least one grade 3 or 4 toxicity. |
| Conclusions: | The combination of FOLFOX, bevacizumab and erlotinib led to higher than expected early withdrawal due to toxicity, limiting conclusions regarding efficacy. These findings raise concern regarding the tolerability of adding more agents to already complex combination regimens for metastatic colorectal cancer. |