Table 2. Dose-escalation strategy.
DoseLevel | Irinotecan | Cisplatin | Olaparib | Mitomycin C |
---|---|---|---|---|
−1 | Irinotecan 70 mg/m2 on days 1 and 8 | Cisplatin 25 mg/m2 on days 1 and 8 | 50mg twice a day on days 1 and 8 | None |
1 | Irinotecan 70 mg/m2 on days 1 and 8 | Cisplatin 25 mg/m2 on days 1 and 8 | 100 mg twice a day on days 1 and 8 | None |
2 | Irinotecan 70 mg/m2 on days 1 and 8 | Cisplatin 25 mg/m2 on days 1 and 8 | 100mg twice a day on days 1–3, 8–10 | None |
3 | Irinotecan 70 mg/m2 on days 1 and 8 | Cisplatin 25 mg/m2 on days 1 and 8 | 200 mg twice a day on days 1–3, 8–10 | None |
4 | Irinotecan 70 mg/m2 on days 1 and 8 | Cisplatin 25 mg/m2 on days 1 and 8 | 200 mg twice a day on days 1–12 | None |
5 | Irinotecan 70 mg/m2 on days 1 and 8 | Cisplatin 25 mg/m2 on days 1 and 8 | MTD from dose level escalation (−1 to 4) | 5 mg/m2 on day 1 |
Treatment days are in reference to a 28-day treatment cycle