Phase II trial of ifosfamide, fluorouracil, and folinic acid (FIFO regimen) in relapsed and refractory urothelial cancer

Cancer Invest. 1995;13(3):276-9. doi: 10.3109/07357909509094462.

Abstract

There is no known effective salvage chemotherapy for patients with refractory or relapsed urothelial tumors after methotrexate/cisplatin-based regimen. We report the results of a phase II trial with the FIFO regimen that includes from day 1 to 5: fluorouracil 350 mg/m2, folinic acid 20 mg/m2, and ifosfamide 1000 mg/m2, Q4W. Fifteen patients with metastatic measurable urothelial cancer were enrolled in this trial. Previous therapy included M-VAC regimen in 11 patients, CMV regimen in 3 patients, and both regimens in 1 patient. Thirty-one courses were delivered. Toxicity was moderate, including encephalopathy grade 2 in 2 patients and hematological toxicity grade 3 in 2 others. However, an early death occurred on day 1 in a patient who progressed rapidly and died from hepatic insufficiency after initial encephalopathy. No objective response was seen. Twelve patients progressed during FIFO therapy and 3 patients experienced a stable disease. Despite almost encouraging results of fluorouracil and ifosfamide in the literature, their combination according to our schedule is not active in urothelial cancer.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II

MeSH terms

  • Adrenal Gland Neoplasms / drug therapy
  • Adrenal Gland Neoplasms / secondary
  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Bone Neoplasms / drug therapy
  • Bone Neoplasms / secondary
  • Carcinoma, Transitional Cell / drug therapy*
  • Carcinoma, Transitional Cell / secondary*
  • Fluorouracil / administration & dosage
  • Hepatic Encephalopathy / etiology
  • Humans
  • Ifosfamide / administration & dosage
  • Leucovorin / administration & dosage
  • Liver Neoplasms / drug therapy
  • Liver Neoplasms / secondary
  • Lung Neoplasms / drug therapy
  • Lung Neoplasms / secondary
  • Male
  • Middle Aged
  • Neoplasm Recurrence, Local / drug therapy
  • Retroperitoneal Neoplasms / drug therapy
  • Retroperitoneal Neoplasms / secondary
  • Salvage Therapy
  • Treatment Failure
  • Urologic Neoplasms / drug therapy*
  • Urologic Neoplasms / pathology

Substances

  • Leucovorin
  • Fluorouracil
  • Ifosfamide