A phase II study of weekly docetaxel in combination with capecitabine in advanced gastric and gastroesophageal adenocarcinomas

Objective: Docetaxel and capecitabine are active agents in advanced gastric and gastroesophageal (GE) carcinomas. This multi-institutional phase II trial evaluates the combination of docetaxel and capecitabine as first- or second-line treatment in patients with advanced gastric and GE adenocarcinomas. Methods: Patients who had received 1 or no prior chemotherapy regimens were eligible. The chemotherapy regimen consisted of a 21-day cycle with docetaxel 30 mg/m ² administered on days 1 and 8 and capecitabine 825 mg/m² administered twice daily on days 1-14. The primary end point of the study was overall survival (OS). Results: Forty patients were enrolled in the study; 39 received treatment and were evaluable for response and toxicity. The median patient age was 61 years (range 21-84); 8 patients had received prior chemotherapy in the advanced or metastatic setting. Grade 3/4 adverse events occurred in 15 patients (38%), including diarrhea in 5 patients (13%) and hand-foot syndrome in 5 patients (13%). The overall response rate was 32% [95% confidence interval (CI) 16.7-51.4]. The median time to progression and OS were 3.4 months (95% CI 2.7-5.8) and 10.7 months (95% CI 6.1-12.1), respectively. Conclusions: The regimen of docetaxel and capecitabine is a well-tolerated, easily administered and active outpatient regimen for advanced gastric and GE adenocarcinoma.