| General information |
| Database: | DB00114 |
| Objective: | The study objective was to determine the proportion of patients with hepatocellular carcinoma treated with the combination of bevacizumab (B) and erlotinib (E) who were alive and progression free at 16 weeks (16week progression free survival [PFS16]) of continuous therapy. response rate, median PFS, survival, and toxicity. |
| Authors: | Thomas MB, et al |
| Title: | Phase II trial of the combination of bevacizumab and erlotinib in patients who have advanced hepatocellular carcinoma. |
| Journal: | J Clin Oncol |
| Year: | 2009 |
| PMID: | 19139433 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | bevacizumab
|
| Target: | Vascular endothelial growth factor
|
| Cancer Type: | liver cancer |
| Cancer Subtype: | advanced hepatocellular carcinoma not amenable to surgical or regional therapies |
| Therapy Type: | com |
| Therapeutic Combination Type: | 1 |
| Therapeutic Combination Content: | bevacizumab+erlotinib |
| Study Type: | a phase II, openlabel, singlearm, singleinstitution, investigatorinitiated trial |
| Key Patients Feature: | Patients who had advanced hepatocellular carcinoma that was not amenable to surgical or regional therapies, up to one prior systemic treatment; ChildsPugh score A or B liver function; Eastern Cooperative Oncology Group performance status 0, 1, or 2 |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm: B 10 mg/kg every 14 days and E 150 mg orally daily, continuously, for 28day cycles |
| Treatment Info: | pts received Bevacizumab 10 mg/kg every 14 days and Erlotinib 150 mg orally daily, continuously, for 28day cycles. |
| Primary End Point: | alive and progression free at 16 weeks (16week progression free survival [PFS16]) of continuous therapy. |
| Secondary End Point: | response rate, median PFS, survival, and toxicity. |
| Patients Number: | 40 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Ten patients achieved a partial response for a confirmed overall response rate (intenttotreat) of 25%. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | PFS16 was 62.5%, the median PFSevent was 39 weeks (95% CI, 26 to 45 weeks; 9.0 months) |
| Median OS A vs. C: | the median overall survival was 68 weeks (95% CI, 48 to 78 weeks; 15.65 months). |
| Adverse Event(agent arm): | Grades 3 to 4 drugrelated toxicity included fatigue (n = 8; 20%), hypertension (n = 6; 15%), diarrhea (n = 4; 10%) elevated transaminases (n = 4; 10%), gastrointestinal hemorrhage (n = 5; 12.5%), wound infection (n = 2; 5%) thrombocytopenia (n = 1; 2.5%), and proteinuria, hyperbilirubinemia, back pain, hyperkalemia, and anorexia (n = 1 each). |
| Conclusions: | The combination of B + E in patients who had advanced hepatocellular carcinoma showed significant, clinically meaningful antitumor activity. B + E warrant additional evaluation in randomized controlled trials. |