| General information |
| Database: | DB00406 |
| Objective: | Thisphase I trial investigates the safety of combining radiation, 5fluorouracil (5FU) and cisplatin with the epidermal growth factor receptor tyrosine kinase inhibitor, erlotinib, in patients with esophageal carcinoma. |
| Authors: | Dobelbotheyr MC, et al |
| Title: | Epidermal growth factor receptor tyrosine kinase inhibitor, erlotinib, and concurrent 5fluorouracil, cisplatin and radiotherapy for patients with esophageal cancer: a phase I study. |
| Journal: | Anticancer Drugs. |
| Year: | 2006 |
| PMID: | 16317296 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | erlotinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | esophageal cancer |
| Cancer Subtype: | esophageal squamous cell or adenocarcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 3 |
| Therapeutic Combination Content: | erlotinib, and concurrent 5fluorouracil, cisplatin and radiotherapy |
| Study Type: | phase I study |
| Key Patients Feature: | Male or female patients 19 years of age or older withECOG performance status (PS) 0-2 and histologicallyconfirmed esophageal squamous cell or adenocarcinomawere eligible for this study. Demonstration of EGFRoverexpression by the tumor was not required forparticipation in this study. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients received either 50, 100 or 150 mg oral erlotinib/day beginning on the first day of radiation (three patients in each dose cohort). Concurrent cisplatin (75 mg/m2 i.v., days 8 and 36) and 5FU (1000 mg/m2 i.v., days 811 and 3639) were also given with 50.4 Gy thoracic radiation, delivered at 180 cGy/day, 5 days/week. |
| Primary End Point: | MTD, DLT. |
| Secondary End Point: | NA |
| Patients Number: | 11 |
| Trial Results |
| DLT_MTD: | noDLTs were observed at any of the erlotinib dose levels inthis study |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | The major toxicities were diarrhea (grade 1 = 18%, grade 2 = 18%), skin rash (grade 4 = 54.5%), nausea (grade 1 = 18%, grade 2 = 54%, grade 3 = 9%) and dehydration (grade 3 = 27%). All patients experienced esophagitis during treatment (grade 1 = 55%, grade 2 = 32%, grade 3 = 9%, grade 4 = 9%). Two patients were discontinued from the study secondary to nonerlotinibrelated toxicities. |
| Conclusions: | They conclude that thephase I study demonstrates the safety and tolerability of erlotinib delivered at 150 mgday with concurrent 5FU, cisplatin and thoracic radiation. The major toxicities encountered they were grade 12 diarrhea, grade 1 skin rash, grade 13 nausea and grade 3 dehydration. Aphase II study is planned. |