| General information |
| Database: | DB00447 |
| Objective: | To conduct a phase I study incorporating trastuzumab with paclitaxel, cisplatin, and radiation for adenocarcinoma of the esophagus. |
| Authors: | Safran H, et al |
| Title: | Trastuzumab, paclitaxel, cisplatin, and radiation for adenocarcinoma of the esophagus: a phase I study. |
| Journal: | Cancer Invest. |
| Year: | 2004 |
| PMID: | 15581047 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | trastuzumab
|
| Target: | Receptor proteintyrosine kinase erbB2
|
| Cancer Type: | esophageal cancer |
| Cancer Subtype: | adenocarcinoma of the esophagus |
| Therapy Type: | com |
| Therapeutic Combination Type: | 3 |
| Therapeutic Combination Content: | Trastuzumab, paclitaxel, cisplatin, and radiation |
| Study Type: | a phase I study |
| Key Patients Feature: | Patients with adenocarcinoma of the esophagus without distant organ metastases were eligible. |
| Biomarker: | HER2/neu |
| Biomark Analysis: | Eight of 12 patients with HER2/neu overexpression by IHC had an increase in the number of HER2/neu genes, six from amplification of the HER2/ neu gene and two were hypderdiploid for chromosome 17. |
| Control Group Info: | single arm |
| Treatment Info: | Eight of 12 patients with HER2/neu overexpression by IHC had an increase in the number of HER2/neu genes, six from amplification of the HER2/ neu gene and two were hypderdiploid for chromosome 17. |
| Primary End Point: | DLT |
| Secondary End Point: | NA |
| Patients Number: | 12 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | No increase in toxicity was seen with the addition of trastuzumab. One of 12 patients in the trastuzumab arm and 8 of 17 in the control arm had grade 3 esophagitis (p < or = .026). Mean left ventricular ejection fraction for the trastuzumab group was 57% before treatment and 56% after treatment. |
| 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): | No increase in toxicity was seen with the addition of trastuzumab. One of 12 patients in the trastuzumab arm and 8 of 17 in the control arm had grade 3 esophagitis (p < or = .026). Mean left ventricular ejection fraction for the trastuzumab group was 57% before treatment and 56% after treatment. |
| Conclusions: | HER2neu is overexpressed in approximately onethird of esophageal adenocarcinomas. Trastuzumab can be added at full dose to cisplatin, paclitaxel, and radiation. Future studies of trastuzumab in esophageal adenocarcinoma are indicated. |