| General information |
| Database: | DB00915 |
| Objective: | To investigate the combination of erlotinib, capecitabine, and oxaliplatin in patients who were previously treated for metastatic colorectal cancer. |
| Authors: | Meyerhardt JA, et al |
| Title: | Phase II study of capecitabine, oxaliplatin, and erlotinib in previously treated patients with metastastic colorectal cancer. |
| Journal: | J Clin Oncol. |
| Year: | 2006 |
| PMID: | 16622264 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | erlotinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | colorectal cancer |
| Cancer Subtype: | advanced colorectal cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | capecitabine, oxaliplatin, + erlotinib |
| Study Type: | Phase II study |
| Key Patients Feature: | patients were eligible if they had metastatic colorectal cancer that progressed, were intolerant to firstline chemotherapy, or had disease recurrence within 1 year of adjuvant therapy for earlystage disease |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Each 21day cycle consisted of daily oral erlotinib at 150 mg, oral capecitabine at 1, 000 mg/m2 (reduced to 750 mg/m2 after the first 13 patients) twice a day on days 1 to 14, and intravenous oxaliplatin at 130 mg/m2 on day 1. |
| Primary End Point: | efficacy and safety |
| Secondary End Point: | NA |
| Patients Number: | 32 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 25% |
| Disease Control Rate: | 72% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 5.4 months |
| Median OS A vs. C: | 14.7 months |
| Adverse Event(agent arm): | Most common grade 3 to 4 toxicities included diarrhea (38%), nausea/emesis (19%), fatigue (16%), dehydration (16%), and dermatitis (13%); grade 3 or 4 toxicities were reduced with a lotheyr starting dose of capecitabine. |
| Conclusions: | The combination of capecitabine, oxaliplatin, and erlotinib seems to have promising activity against metastatic colorectal cancer in patients who received prior chemotherapy, with a relatively higher response rate and progression free survival compared with previous reports of either infusional FU, leucovorin, and oxaliplatin or capecitabine and oxaliplatin in similar patient populations. |