| General information |
| Database: | DB00914 |
| Objective: | Hepatocellular carcinoma (hepatocellular carcinoma) is a vascular tumor with poor prognosis. Given the reported activity of gemcitabine and oxaliplatin (GEMOX) in hepatocellular carcinoma and the potential benefits of targeting the vascular endothelial growth factor pathway with bevacizumab (B), a phase II study of GEMOXB was undertaken to define efficacy and toxicity profiles in hepatocellular carcinoma patients |
| Authors: | Zhu AX, et al |
| Title: | Phase II study of gemcitabine and oxaliplatin in combination with bevacizumab in patients with advanced hepatocellular carcinoma. |
| Journal: | J Clin Oncol. |
| Year: | 2006 |
| PMID: | 16622265 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | bevacizumab
|
| Target: | Vascular endothelial growth factor
|
| Cancer Type: | liver cancer |
| Cancer Subtype: | advanced hepatocellular carcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | gemcitabine + oxaliplatin + bevacizumab |
| Study Type: | Phase II study |
| Key Patients Feature: | Eligible patients had pathologically proven measurable unresectable or metastatic hepatocellular carcinoma. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | For cycle 1 (14 days), bevacizumab 10 mg/kg was administered alone intravenously on day 1. For cycle 2 and beyond (28 days/cycle), bevacizumab 10 mg/kg was administered on days 1 and 15, gemcitabine 1, 000 mg/m2 was administered as a dose rate infusion at 10 mg/m2/min followed by oxaliplatin at 85 mg/m2 on days 2 and 16. |
| Primary End Point: | efficacy and safety |
| Secondary End Point: | NA |
| Patients Number: | 33 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 20% |
| Disease Control Rate: | 47% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 9.6 months (95% CI, 8.0 months to not available) |
| Median OS A vs. C: | 9.6 months (95% CI, 8.0 months to not available) |
| Adverse Event(agent arm): | The most common treatmentrelated grade 3 to 4 toxicities included leukopenia/neutropenia, transient elevation of aminotransferases, hypertension, and fatigue. |
| Conclusions: | GEMOXB could be safely administered with close monitoring and had moderate antitumor activity for patients with advanced hepatocellular carcinoma. The high 6month PFS rate is encouraging, and this regimen is worthy of further investigation. |