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Cancer Invest. 2009 May;27(4):402-6. doi: 10.1080/07357900802406327.

Phase I study of weekly cisplatin, bolus fluorouracil and escalating doses of irinotecan in advanced solid tumors.

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  • 1Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10065, USA.



We performed a phase I study of 5-fluorouracil (5-FU), cisplatin and irinotecan.


Twenty-nine patients received cisplatin 25 mg/m(2) and bolus 5-FU 425 mg/m(2), along with irinotecan at 40, 50, and 65 mg/m(2) weekly for 4 out of 6 weeks.


The maximum tolerated dose (MTD) for untreated patients was irinotecan 65 mg/m(2) while the MTD for previously treated patients was irinotecan 40 mg/m(2). Neutropenia and diarrhea were the major dose-limiting toxicities. Antitumor activity was noted in gastric, esophageal and pancreatic cancers.


Because of the toxicity profile, combinations with continuous infusion 5-FU or capecitabine should be explored.

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