A phase I trial of fluorouracil, leucovorin, and recombinant interferon α-2b in patients with advanced malignancy

Charles W. Taylor, Manuel R. Modiano, Mark E. Woodson, Stephen G. Marcus, David S. Alberts, Evan M. Hersh

Research output: Contribution to journalArticle

9 Scopus citations


We conducted a phase I trial of fluorouracil (5-FU), leucovorin, (LCV), and recombinant interferon-α-2b (rIFNα-2b). The doses of each of the three agents were escalated sequentially. 5-FU and LCV were administered by IV bolus, weekly for 6 weeks and rIFN-α-2b was administered by subcutaneous injection, three times weekly for 6 weeks. Twenty-nine patients with advanced cancer (75% colon or pancreatic cancer) were treated. Partial remissions were observed in three patients (10%) with previously untreated colon cancer, colon cancer refractory to 5-FU plus LCV and previously untreated pancreatic cancer, respectively. An additional three patients with pancreatic, prostate, and rectal cancer had a 50% reduction in tumor markers but no change in objective tumor measurements. The toxicity of this regimen was tolerable. The most common toxicities were diarrhea, fatigue, flu-like symptoms, nausea/vomiting, and mucositis. However, no fatal or life-threatening toxicities were observed. We conclude that the combination of 5-FU, LCV, and rIFN-α-2b can be safely administered and recommend further evaluation of this regimen in patients with tumors of gastrointestinal origin using doses of 5-FU 600 mg/m2, LCV 500 mg/m2, and rIFN-α-2b 10 × 106 U.

Original languageEnglish (US)
Pages (from-to)185-190
Number of pages6
JournalSeminars in Oncology
Issue number2 SUPPL. 3
StatePublished - Apr 1992


ASJC Scopus subject areas

  • Hematology
  • Oncology

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