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

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

Abstract

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

Methods: 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.

Results: 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.

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

Publication types

  • Clinical Trial, Phase I

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Camptothecin / administration & dosage
  • Camptothecin / analogs & derivatives
  • Cisplatin / administration & dosage
  • Diarrhea / chemically induced
  • Digestive System Neoplasms / drug therapy*
  • Digestive System Neoplasms / pathology
  • Disease Progression
  • Drug Administration Schedule
  • Esophageal Neoplasms / drug therapy
  • Female
  • Fluorouracil / administration & dosage
  • Humans
  • Infusions, Intravenous
  • Injections, Intravenous
  • Irinotecan
  • Male
  • Maximum Tolerated Dose
  • Middle Aged
  • Neutropenia / chemically induced
  • Pancreatic Neoplasms / drug therapy
  • Stomach Neoplasms / drug therapy
  • Time Factors
  • Treatment Outcome

Substances

  • Irinotecan
  • Cisplatin
  • Fluorouracil
  • Camptothecin