Capecitabine, Oxaliplatin and Radiotherapy: A Phase IB Neoadjuvant Study for Esophageal Cancer with Gene Expression Analysis

PURPOSE: To determine the maximal tolerated dose of capecitabine with oxaliplatin + radiotherapy in a phase I study of localized esophageal cancer. PATIENTS AND METHODS: Oxaliplatin (85 mg/m(2)) administered on days 1, 15, and 29. Capecitabine administered twice daily 5 days weekly; dose levels (DL) were 1, 1000; 2, 1250; and 3, 1500 mg/m(2) with 50.4 Gy radiation. RESULTS: Dose-limiting toxicity was reached at DL 3. Carboxylesterase expression in day 2 tumor specimens and induction correlated with response (p <or= 0.05). CONCLUSION: The maximal tolerated dose was 85 mg/m(2) of oxaliplatin, 1,250 mg/m(2)/day of capecitabine, and 50.4 Gy of radiation.