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UFT/calcium folinate plus weekly paclitaxel for solid tumors.

C Bokemeyer1, J T Hartmann, C Kollmannsberger

  • 1Eberhard-Karls-Universität Tübingen, Innere Medizin II, Germany.

Oncology (Williston Park, N.Y.)
|August 12, 1999
PubMed
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This Phase I study evaluated oral Uracil and tegafur (UFT) with calcium folinate combined with weekly paclitaxel for solid tumors. The combination showed promising activity and tolerability, establishing a dose for further research.

Area of Science:

  • Oncology
  • Clinical Pharmacology

Background:

  • Cancer palliation and quality of life are crucial due to incurable cases.
  • Oral Uracil and tegafur (UFT) plus calcium folinate (Orzel) shows efficacy similar to intravenous 5-fluorouracil (5-FU).
  • Weekly paclitaxel (Taxol) offers high dose intensity and response rates with manageable toxicity.

Purpose of the Study:

  • To determine dose-limiting toxicity (DLT) of the UFT/calcium folinate plus paclitaxel combination.
  • To assess potential antitumor activity of the combination therapy.
  • To establish an appropriate dose for Phase II studies.

Main Methods:

  • Phase I clinical trial design.
  • Fixed daily dose of UFT (300 mg/m2) and calcium folinate (90 mg) orally for 4 weeks.
  • Weekly escalating doses of paclitaxel (starting at 50 mg/m2 in 10 mg/m2 increments).

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Main Results:

  • Dose-limiting toxicities were identified during paclitaxel escalation.
  • Preliminary antitumor activity was observed in patients with solid tumors.
  • A recommended dose for Phase II trials was established based on safety and tolerability.

Conclusions:

  • The combination of oral UFT/calcium folinate with weekly paclitaxel is a feasible and potentially active outpatient regimen.
  • This approach advances oral administration of 5-FU-like agents combined with dose-dense paclitaxel.
  • Further investigation in Phase II trials for various solid tumors is warranted.