Phase II study of continuous 120-hour-infusion of mitomycin C as salvage chemotherapy in patients with progressive or rapidly recurrent gastrointestinal adenocarcinoma.

The aim of the study was to evaluate the therapeutic activity and safety of continuously infused (c.i.) mitomycin C in patients with metastatic gastrointestinal adenocarcinomas recurring after or progressing during chemotherapy. The patients were treated with mitomycin C 20 mg/m2 intravenously over a time period of 120 hours, followed by a 3-week rest. Seventy-eight patients were entered into the study. All the patients were assessable for toxicity and 72 for response evaluation, having completed at least one full course of chemotherapy. Among 52 colorectal cancer patients one single objective response (2%) was observed. Disease stabilisation was achieved in 11 patients (23%). Median survival time was 4.7 months (CI95%, 1.9 to 8.6). In 20 evaluable patients with gastric cancer, one complete and 5 partial remissions were observed [ORR: 30% (CI95%, 9.1-50.9%)]. The median response duration was 2.1 months (range, 2 to 6), and the median survival time 3.6 months (CI95%, 2.1 to 6.0). WHO degree III/IV mucositis, diarrhea and fever/infection each occurred in 6% of the patients. Thrombo- and leukocytopenia (WHO degree III/IV) occurred in 19% and 6% of the patients, respectively. Mitomycin C has some single-agent activity in advanced gastric cancer but no substantial efficacy was seen as in heavily pretreated colorectal carcinoma.