Cancer Chemotherapy and Pharmacology

, Volume 26, Issue 1, pp 57–61

Biological Modification of protracted infusion of 5-fluorouracil with weekly leucovorin

A dose seeking clinical trial for patients with disseminated gastrointestinal cancers
  • Cynthia Gail Leichman
  • Lawrence Leichman
  • C. Paul Spears
  • Peter J. Rosen
  • Franco Muggia
  • Susan Jeffers
  • William Waugh
Article

Summary

A clinical trial was designed to find the maximally tolerated dose of weekly leucovorin (LV) that could be combined with 4 weeks of protracted infusion (PI) of 5-fluorouracil (5FU) at a fixed soe of 200 mg/m2. A total of 36 patients with disseminated gastrointestinal malignancies were treated; 9 either progressed or died before receiving 4 weeks of treatment leaving 27 patients evaluable for toxicity and response. 5FU was given as a protracted infusion using an ambulatory infusion pump and indwelling venous access. LV doses included 20, 25, 50, and 75 mg/m2 given as an i. v. push at the time of weekly pump fill with 5FU. In all, 72% of the patients tolerated LV at 20 mg/m2 for 4 continous weeks, whereas the higher doses required treatment rests prior to 4 weeks. The dose-limiting toxicity at all doses was stomatitis. No significant myelosuppression was seen; diarrhea was infrequent. Overall, 40% of the patients with measurable cancer had partial responses. In view of evidence of biologic and therapeutic effects of these weekly doses of 20 mg/m2 LV with 200 mg/m2 5FU per day given as a protracted infusion over 4 weeks, phase II trials and multimodality studies for patients with gastrointestinal malignancies are being initiated at our institution using this dose and schedule.

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Copyright information

© Springer-Verlag 1990

Authors and Affiliations

  • Cynthia Gail Leichman
    • 1
  • Lawrence Leichman
    • 1
  • C. Paul Spears
    • 1
  • Peter J. Rosen
    • 1
  • Franco Muggia
    • 1
  • Susan Jeffers
    • 1
  • William Waugh
    • 2
  1. 1.Division of Medical OncologyThe University of Southern CaliforniaLos AngelesUSA
  2. 2.University of Southern California School of PharmacyLos AngelesUSA
  3. 3.Division of Medical OncologyKenneth Norris Cancer Jr. Cancer Hospital University of Southern CaliforniaUSA

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