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Vol. 78, No. 2, 2010
Issue release date: April 2010
Oncology 2010;78:125–129

A Phase II Study of Weekly Docetaxel in Combination with Capecitabine in Advanced Gastric and Gastroesophageal Adenocarcinomas

Lo S.S. · Khorana A.A. · Javle M. · Simon S. · Kiefer G. · Rajasenan K. · Wang H. · Hantel A. · Shayne M. · Hwang J. · Schmotzer A. · Ramanathan R.K.
aLoyola University Stritch School of Medicine, Maywood, Ill., bUniversity of Rochester School of Medicine and Dentistry, Rochester, N.Y., cRoswell Park Cancer Institute, Buffalo, N.Y., dUniversity of Pittsburgh Cancer Institute, Pittsburgh, Pa., eEdward Hospital, Naperville, Ill., and fLombardi Cancer Center, Georgetown University, Washington, D.C., USA

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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/m2 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.

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