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 gastro intestinal adenocarcinomas recurring after or progressing during chemothera py. The patients were treated with mitomycin C 20 mg/m(2) intravenously ove r a time period of 120 hours, followed by a 3-week rest. Seventy-eight pati ents were entered into the study. All the patients were assessable for toxi city and 72 for response evaluation, having completed at least one full cou rse of chemotherapy. Among 52 colorectal cancer patients one single objecti ve response (2%) was observed. Disease stabilisation was achieved in 11 pat ients (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 remissi ons were observed [ORR: 30% (CI95% 9.1-50.9%)]. The median response duratio n was 2.1 months (range, 2 to 6), and the median survival time 3.6 months ( CI95%, 2.1 to 6.0). WHO degrees III/IV mucositis, diarrhea and fever/infect ion each occurred in 6% of the patients. Thrombo- and leukocytopenia (WHO d egrees III/IV) occurred in 19% and 6% of the patients, respectively. Mitomy cin C has some single-agent activity in advanced gastric cancer but no subs tantial efficacy was seen as in heavily pretreated colorectal carcinoma.