Phase I study of eniluracil and oral 5-fluorouracil in combination with docetaxel in the treatment of patients with metastatic breast carcinoma

Edgardo Rivera, Vicente Valero, Massimo Cristofanilli, Debra K. Frye, Daniel J. Booser, Marguerite M. Rosales, Gabriel N. Hortobagyi

Research output: Contribution to journalArticlepeer-review

3 Scopus citations


PURPOSE. The authors conducted a single-institution Phase I clinical trial to determine the maximum tolerated doses and to define the toxic effects of oral eniluracil and oral 5-fluorouracil (5-FU) combined with docetaxel in patients with metastatic breast carcinoma. PATIENTS AND METHODS. Patients with metastatic breast carcinoma were eligible if they had disease progression after anthracycline-based therapy and had never been exposed to taxanes. The starting doses of oral eniluracil and oral 5-FU were 11.5 mg/m2 and 1.15 mg/m2, respectively, twice daily on Days 1-14. Docetaxel was given intravenously at a starting dose of 50 mg/m2 on Day 1 only. The dose of docetaxel was escalated among cohorts until a maximum tolerated dose was reached. Courses were repeated every 21 days. RESULTS. The authors treated 19 patients with Stage IV breast carcinoma, of whom 5 had received prior chemotherapy for their metastatic disease. Fifty-three percent had a performance status of 1, and 53% had bone or soft tissue involvement as the dominant site of disease. All patients had received prior therapy with doxorubicin. The dose-limiting toxicity was neutropenic fever. No episodes of sepsis were observed. Significant antitumor activity was observed with a total of two complete and nine partial responses. The recommended doses for Phase II studies are 72 mg/m2 docetaxel on Day 1 and 10.0/1.0 mg/m2 oral eniluracil/5-FU twice daily for a total of 14 days, with courses being repeated every 21 days. CONCLUSIONS. The combination of oral eniluracil/5-FU and intravenous docetaxel is a safe and well tolerated regimen. Significant antitumor activity is associated with this combination.

Original languageEnglish (US)
Pages (from-to)2321-2326
Number of pages6
Issue number9
StatePublished - May 1 2002


  • 5-fluorouracil
  • Antitumor activity
  • Dose-limiting toxicities
  • Eniluracil
  • Metastatic breast carcinoma

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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