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Phase I study of UFT plus leucovorin with radiotherapy in patients with inextirpable non-rectal gastrointestinal cancer.

AbstractBACKGROUND AND PURPOSE:
Chemoradiotherapy is increasingly used in the primary management of patients with loco-regionally advanced gastrointestinal (GI) cancer. Oral chemotherapy with uracil and tegafur (UFT) plus leucovorin (LV) may represent a convenient way of delivering protracted infusion of fluorouracil. Our goal was to evaluate the safety of UFT plus LV combined with radiation and determine the maximum-tolerated dose (MTD) and a recommended dose for further testing.
PATIENTS AND METHODS:
Patients with inextirpable GI cancer received escalating doses of UFT (starting at 300 mg/m(2)/d with 50 mg/m(2)/d increments between consecutive cohorts) and fixed doses of LV (90 mg/d). UFT and LV were given 5 days per week concurrently with radiation to 50 Gy (2 Gy/fraction).
RESULTS:
Twenty-five patients were treated, and 22 received the planned treatment. Three patients were withdrawn from treatment, two due to disease-progression and one due to toxicity. The MTD of UFT with radiation was 400 mg/m(2)/d with 90 mg/d of LV. Diarrhoea was the main dose limiting toxicity (DLT). Since some toxicity (3/12 DLTs) was seen in the expanded cohort at the level below, but none (0/9 DLT) at the starting level, the recommended dose chosen for further testing is 300-350 mg/m(2)/d depending upon the size of the target volume.
CONCLUSION:
Concomitant chemoradiation with oral UFT plus LV is feasible and well tolerated and should be further investigated since tumour responses were frequently seen.
AuthorsP Byström, J-E Frödin, A Berglund, N Wilking, B Glimelius
JournalRadiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology (Radiother Oncol) Vol. 70 Issue 2 Pg. 171-5 (Feb 2004) ISSN: 0167-8140 [Print] Ireland
PMID15028404 (Publication Type: Clinical Trial, Clinical Trial, Phase I, Comparative Study, Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Tegafur
  • Uracil
  • Leucovorin
Topics
  • Administration, Oral
  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols (administration & dosage)
  • Female
  • Follow-Up Studies
  • Gastrointestinal Neoplasms (drug therapy, mortality, pathology, radiotherapy)
  • Humans
  • Leucovorin (administration & dosage)
  • Male
  • Maximum Tolerated Dose
  • Middle Aged
  • Neoplasm Staging
  • Prospective Studies
  • Radiotherapy Dosage
  • Radiotherapy, Adjuvant
  • Risk Assessment
  • Survival Analysis
  • Tegafur (administration & dosage)
  • Terminally Ill
  • Treatment Outcome
  • Uracil (administration & dosage)

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