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Background: Previously, we reported that the maximum tolerated dose (MTD) of biweekly administration of irinotecan (CPT-11) plus cisplatin (CDDP) was 70 mg/m plus 30 mg/m, respectively. The same biweekly regimen was combined with intestinal alkalization to address delayed diarrhea in this phase I study. Methods: CPT-11 plus CDDP were administered biweekly with an antidiarrheal program consisting of sodium bicarbonate and magnesium oxide to patients with various malignancies. CDDP dosing was fixed at 30 mg/m and dose escalation of CPT-11 from 60 mg/m to 100 mg/m by a step of 10 mg/m was used. Results: A total of 22 patients (Level I (60 mg/m): 3 patients, Level II (70 mg/m): 3 patients, Level III (80 mg/m): 7 patients, Level IV (90 mg/m): 6 patients, and Level V (100 mg/m): 3 patients) entered into this study. Of the 22 patients, diarrhea of grade 2 and 3 was observed in 3 patients and 1 patient (5%), respectively. At Level IV, 2 patients experienced grade 3 neutropenia, and one of the 2 patients coincidentally had grade 3 thrombocytopenia and grade 3 diarrhea. At Level V, there were no patients with dose limiting toxicities, but 2 of the 3 patients could not be dosed more than three times. Of the 22 patients, 19 patients were assessed for response. One and 12 patient had partial response and stable disease, respectively, resulting in a disease control rate of 68%. Conclusion: Intestinal alkalization could prevent CPT-11-induced diarrhea and increase MTD of biweekly 100 mg/m of CPT-11 with CDDP 30 mg/m administration.

annals of cancer research and therapy

BIWEEKLY ADMINISTRATION OF IRINOTECAN (CPT-11) PLUS CISPLATIN WITH AN ANTIDIARRHEAL PROGRAM OF INTESTINAL ALKALIZATION TO REDUCE DIARRHEA IN CANCER PATIENTS