| General information |
| Database: | DB00932 |
| Objective: | Gallbladder cancers and cholangiocarcinomas make up a heterogenous group of tumours with a poor prognosis in advanced stages. On the basis of evidence of dysregulation of the epidermal growth factor receptor, vascular endothelial growth factor and mitogenactivated protein kinase pathways in biliary cancers, they performed a phase 2 trial of sorafenib and erlotinib in patients with advanced biliary cancers |
| Authors: | ElKhoueiry AB, et al |
| Title: | S0941: a phase 2 SWOG study of sorafenib and erlotinib in patients with advanced gallbladder carcinoma or cholangiocarcinoma. |
| Journal: | Br J Cancer. |
| Year: | 2014 |
| PMID: | 24423918 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | sorafenib and erlotinib
|
| Target: | NA
|
| Cancer Type: | bladder cancer |
| Cancer Subtype: | Gallbladder cancers |
| Therapy Type: | com |
| Therapeutic Combination Type: | 1 |
| Therapeutic Combination Content: | sorafenib + erlotinib |
| Study Type: | a phase II SWOG study |
| Key Patients Feature: | Eligible patients were previously untreated in the advanced setting with adequate hepatic and bone marrow function. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Sorafenib and erlotinib were administered continuously at 400 mg BID and 100 mg daily, respectively. |
| Primary End Point: | efficacy and safety |
| Secondary End Point: | NA |
| Patients Number: | 34 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 6% |
| Disease Control Rate: | 35% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 2 months (95% CI: 23) |
| Median OS A vs. C: | 6 months (95% CI: 38 months) |
| Adverse Event(agent arm): | Thirtyfour patients were evaluated for adverse events. One patient died on protocol therapy after being admitted for abdominal pain. The most common grade 3 and 4 toxicities that were at least possibly related to study drugs and occurred in two or more patients were hypertension (15%), ALT increase (12%), alkaline phosphatase increase (9%), diarrhoea (9%), hypophosphatemia (9%), AST increase (9%), bilirubin increase (6%), handfoot skin reaction (6%), hepatic infection (6%), hypokalaemia (6%) and rash (6% ) |
| Conclusions: | Despite compelling preclinical rationale, the combination of sorafenib and erlotinib does not have promising clinical activity in an unselected population of patients with biliary cancers. Improved patient selection based on tumour biology and molecular markers is critical for future evaluation of targeted therapies in this disease |