A prospective phase I/II trial of capecitabine with escalating mitomycin C and oxaliplatin in patients with advanced or metastatic esophageal carcinoma

15555 Background: In preclinical studies, mitomycin C (MMC) was found to upregulate thymidine phophorylase thereby enhancing cytotoxic activity of capecitabine. Moreover, capecitabine shows promising activity in combination with oxaliplatin in patients with esophageal cancer. Therefore, we conducted a prospective phase I/II trial of the combination of capecitabine, MMC, and oxaliplatin in patients with unresectable advanced esophageal carcinoma. Methods: Capecitabine (2,000 mg/m2, bid, d1–14) and oxaliplatin (100 mg/m2, q3 weeks) were kept constant while MMC was escalated: 6–10 mg/m2, q 6 weeks. Results: 25 pts (3 F, 22 M) received 171 cycles (median 7). Median age was 64 years (41–70). Dose-limiting toxicities were grade 4 thrombocytopenia or grade 4 neutropenia. No patients died from adverse events related drug toxicity. The maximal tolerable dose (MTD) for MMC was 6 mg/m2, q6 weeks. Partial response was seen in 10/25 pts (40%), stable disease in 11/25 pts (44%) and progressive disease in 4/25 pts (16%)...