| General information |
| Database: | DB00909 |
| Objective: | Epidermal growth factor receptor (EGFR) and ligand expression is frequently seen in hepatocellular carcinoma (hepatocellular carcinoma). a phase 2 study was performed with cetuximab, a chimeric monoclonal antibody that binds specifically to EGFR, in patients with advanced hepatocellular carcinoma. |
| Authors: | Zhu AX, et al |
| Title: | Phase 2 study of cetuximab in patients with advanced hepatocellular carcinoma. |
| Journal: | Cancer. |
| Year: | 2007 |
| PMID: | 17583545 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | liver cancer |
| Cancer Subtype: | advanced hepatocellular carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Phase II study |
| Key Patients Feature: | Eligibility criteria included unresectable or metastatic measurable hepatocellular carcinoma, an Eastern Cooperative Oncology Group performance status |
| Biomarker: | EGFR expression |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | The initial dose of cetuximab was 400 mg/m(2) given intravenously follotheyd by weekly intravenous infusions at 250 mg/m(2). Each cycle was defined as 6 consecutive weekly treatments. EGFR expression was assayed by immunohistochemistry and trough serum concentrations of cetuximab were determined during the first cycle. |
| Primary End Point: | efficacy and safety |
| Secondary End Point: | NA |
| Patients Number: | 30 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | 17% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 1.4 months (95% CI, 1.22.6 months). |
| Median OS A vs. C: | 9.6 months (95% confidence interval [CI], 4.312.1 months) |
| Adverse Event(agent arm): | No treatmentrelated grade 45 toxicities occurred. Grade 3 (according to the National Cancer Institute's Common Terminology Criteria for Adverse Events [version 3.0]) aspartate aminotransferase, hypomagnesemia, and fever without neutropenia were noted in 1 patient (3.3%) each. |
| Conclusions: | Although cetuximab could be safely administered with tolerable toxicity profiles, it demonstrated no antitumor activity in hepatocellular carcinoma in thisphase 2 study. Cetuximab trough concentrations were not notably altered in patients with mild to moderate hepatic dysfunction. |