Phase I Study of Weekly Cisplatin, Bolus Fluorouracil and Escalating Doses of Irinotecan in Advanced Solid Tumors

Abstract

Purpose: We performed a phase I study of 5-fluorouracil (5-FU), cisplatin and irinotecan. Methods: Twenty-nine patients received cisplatin 25 mg/m² and bolus 5-FU 425 mg/m², along with irinotecan at 40, 50, and 65 mg/m² weekly for 4 out of 6 weeks. Results: The maximum tolerated dose (MTD) for untreated patients was irinotecan 65 mg/m² while the MTD for previously treated patients was irinotecan 40 mg/m². Neutropenia and diarrhea were the major dose-limiting toxicities. Antitumor activity was noted in gastric, esophageal and pancreatic cancers. Conclusion: Because of the toxicity profile, combinations with continuous infusion 5-FU or capecitabine should be explored.

Keywords:

• Cisplatin
• 5-Fluorouracil
• Irinotecan
• Phase I trial