| General information |
| Database: | DB00945 |
| Objective: | Bevacizumab has demonstrated antitumor activity in multiple diseases. Thisphase II study was undertaken to determine the effects of adding bevacizumab to a regimen of docetaxel and oxaliplatin in patients with advanced adenocarcinoma of the stomach or gastroesophageal junction. |
| Authors: | ElRayes BF, et al |
| Title: | a phase II study of bevacizumab, oxaliplatin, and docetaxel in locally advanced and metastatic gastric and gastroesophageal junction cancers. |
| Journal: | Ann Oncol. |
| Year: | 2010 |
| PMID: | 20332133 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | bevacizumab
|
| Target: | Vascular endothelial growth factor
|
| Cancer Type: | esophagusgastroesophageal junction cancer |
| Cancer Subtype: | adenocarcinoma of the stomach or gastroesophageal junction |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | bevacizumab, oxaliplatin, + docetaxel |
| Study Type: | a phase II study |
| Key Patients Feature: | Previously untreated patients with locally advanced or metastatic disease and a performance status (PS) of 01 were eligible for this study. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients received bevacizumab at 7.5 mg/kg, docetaxel at 70 mg/m(2), and oxaliplatin at 75 mg/m(2) administered on day 1 of a 21day cycle. |
| Primary End Point: | progression free survival (PFS). |
| Secondary End Point: | NA |
| Patients Number: | 38 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 39% |
| Disease Control Rate: | 76% |
| Median Time to Progression: | 4.5 months (95% CI 3.6-6.3 months). |
| Median PFS A vs. C: | 6.6 months [95% confidence interval (CI) 4.410.5] |
| Median OS A vs. C: | 11.1 months (95% CI 8.215.3) |
| Adverse Event(agent arm): | The most commonly reported grade 3-4 toxicity was neutropenia (34%), and gastrointestinal perforation occurred in three patients (8%). |
| Conclusions: | The combination of bevacizumab, docetaxel, and oxaliplatin has promising activity for further evaluation in randomized trials |