| General information |
| Database: | DB00118 |
| Objective: | Epidermal growth factor receptor/human epidermal growth factor receptor 1 and ligand expression is common in biliary cancers (BILI) and may be associated with worse outcome. The primary objective of this study was to determine the proportion of patients with advanced BILI who were progression free at 6 months. |
| Authors: | Philip PA, et al |
| Title: | Phase II study of erlotinib in patients with advanced biliary cancer. |
| Journal: | J Clin Oncol. |
| Year: | 2006 |
| PMID: | 16809731 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | erlotinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | biliary tract and gallbladder cancer |
| Cancer Subtype: | advanced BILI |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a phase II study |
| Key Patients Feature: | Patients with either unresectable or metastatic disease, Only one prior systemic or locoregional therapy was allowed. |
| Biomarker: | HER1/EGFR expression by immunohistochemistry in tumor cells was detected in 29 (81%) of the 36 assessable patients. |
| Biomark Analysis: | HER1/EGFR expression by immunohistochemistry in tumor cells was detected in 29 (81%) of the 36 assessable patients. |
| Control Group Info: | single arm |
| Treatment Info: | Erlotinib was administered continuously at a dose of 150 mg per day orally. |
| Primary End Point: | the progression free survival of patients with BILI treated with erlotinib 150 mg per day. |
| Secondary End Point: | adverse event profile, objective response assessment, and overall survival. |
| Patients Number: | 42 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Three patients had partial response by Response Evaluation Criteria in Solid Tumors Group classification of duration 4, 4, and 14 months, respectively. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 7 of the patients (17%;95% CI, 7% to 31%) were progression free at 6 months. |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | All responding patients had mild (grade 1/2) skin rash and two patients had positive tumoral HER1/EGFR expression. Three patients (7%) had toxicityrelated dose reductions of erlotinib due to grade 2/3 skin rash. |
| Conclusions: | Results suggest a therapeutic benefit for EGFR blockade with erlotinib in patients with biliary cancer. Additional studies with erlotinib as a single agent and in combination with other targeted agents are warranted in this disease. |