Entry Detail
| General information | |
| Database: | DB00116 |
| Objective: | To evaluate the response to lapatinib in patients with advanced bilary tree cancer (BTC) and hepatocellular cancer (hepatocellular carcinoma). |
| Authors: | Ramanathan RK, et al |
| Title: | a phase II study of lapatinib in patients with advanced biliary tree and hepatocellular cancer. |
| Journal: | Cancer Chemother Pharmacol. |
| Year: | 2009 |
| PMID: | 19169683 |
| Trial Design | |
| Clinical Trial Id: | NA |
| Agent: | lapatinib |
| Target: | Epidermal growth factor receptor Receptor proteintyrosine kinase erbB2 |
| Cancer Type: | biliary tract, gallbladder cancer and liver cancer |
| Cancer Subtype: | advanced bilary tree cancer (BTC) and hepatocellular cancer (hepatocellular carcinoma). |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | an openlabel, singlearm, phase II study |
| Key Patients Feature: | histological or cytological confirmation of hepatocellular carcinoma or BTC and were not candidates for surgery or local ablative procedures. Patients were required to have measurable disease, less than and equal to 1 prior chemotherapy (including TACE) for metastatic or recurrent disease and the ability to swallow and retain oral medications. |
| Biomarker: | EGFR genotyping |
| Biomark Analysis: | EGFR genotyping indicated hepatocellular carcinoma patients with <20 repeats have the lotheyst PFS. |
| Control Group Info: | single arm |
| Treatment Info: | Lapatinib was dosed at 1, 500 mg/day orally continuously. |
| Primary End Point: | ORR, PFS, OS |
| Secondary End Point: | NA |
| Patients Number: | 57 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | The response in BTC was 0% and in hepatocellular carcinoma was 5%. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | The progression free survival (PFS) for BTC and hepatocellular carcinoma patients was 1.8 (95% CI: 1.75.2) months and 2.3 (95% CI: 1.75.6) months.EGFR genotyping indicated hepatocellular carcinoma patients with <20 repeats have the lotheyst PFS. The occurrence of any skin rash significantly prolonged PFS and survival. |
| Median OS A vs. C: | The median survival for BTC and hepatocellular carcinoma patients was 5.2 (95% CI 3.3infinity) months and 6.2 (95% CI: 5.1infinity) months. |
| Adverse Event(agent arm): | Therapy was well tolerated in both BTC and hepatocellular carcinoma subjects. Twentyfour of 57 patients (47%) required at least one dose modification, and 4 patients (7%) discontinued therapy due to toxicity. Most dose reductions occurred in patients who had received more than and equal to 4 cycles of therapy. |
| Conclusions: | Lapatinib was welltolerated. There was evidence of activity in hepatocellular carcinoma, but therapy with lapatinib did not meet the predefined efficacy rate. |