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CPT-11. The European experience

J P Armand1, C Terret, C Couteau

  • 1Institut Gustave Roussy, Villejuif, France.

Annals of the New York Academy of Sciences
|December 13, 1996
PubMed
Summary

Irinotecan (CPT-11), a topoisomerase I inhibitor, demonstrated promising efficacy in Phase I trials for various cancers. A recommended dose of 350 mg/m2 every three weeks was established for further study.

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Area of Science:

  • Oncology
  • Pharmacology
  • Clinical Trials

Background:

  • CPT-11 is a camptothecin derivative with broad-spectrum antitumor activity.
  • CPT-11 selectively inhibits the DNA enzyme topoisomerase I.
  • Phase I trials were initiated to determine optimal dosing and scheduling for CPT-11.

Purpose of the Study:

  • To assess the toxicity and tolerability of CPT-11 across different administration schedules.
  • To determine the maximum tolerated dose (MTD) and recommended dose for Phase II trials.
  • To explore the potential of CPT-11 in combination therapies.

Main Methods:

  • Conducted Phase I clinical trials involving 235 patients.
  • Evaluated three distinct CPT-11 administration schedules: every three weeks, weekly for three weeks, and daily for three consecutive days.
  • Assessed dose-limiting toxicities, particularly diarrhea, and explored combination therapy with loperamide and 5-fluorouracil (5-FU).

Main Results:

  • The MTD varied by schedule: 115 mg/m2 (daily) and 145 mg/m2 (weekly).
  • The every-three-week schedule showed the best tolerability and highest dose intensity, with diarrhea as the dose-limiting toxicity above 350 mg/m2.
  • Combination with loperamide allowed CPT-11 doses up to 750 mg/m2; preliminary results with 5-FU showed no pharmacokinetic interaction.

Conclusions:

  • A dose of 350 mg/m2 of CPT-11, administered intravenously over 30 minutes every three weeks, is recommended for Phase II trials.
  • CPT-11 has shown significant efficacy in colorectal cancer, including 5-FU-resistant cases, and promising results in pancreatic, cervical, and lung cancers.
  • Further trials will investigate CPT-11's role in combination with other cytotoxic agents or radiotherapy.

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