Phase I/II trial of outpatient docetaxel, cisplatin, 5-fluorouracil, leucovorin (opTPFL) as induction for squamous cell carcinoma of the head and neck (SCCHN)

A. D. Colevas, C. M. Norris, R. B. Tishler, C. C. Lamb, M. P. Fried, L. A. Goguen, H. V. Gopal, R. Costello, R. Read, S. Adak, M. R. Posner

Research output: Contribution to journalArticle

45 Scopus citations

Abstract

The purpose of this study was to establish the maximum tolerated dose (MTD) of docetaxel in an outpatient docetaxel (T), cisplatin (P), 5-fluorouracil (5-FU) (F), and leucovorin (L) (opTPFL) regimen and to obtain preliminary assessment of opTPFL efficacy. Thirty-four patients with stage III or IV squamous cell carcinoma of the head and neck were treated with opTPFL. Docetaxel was escalated from 60 to 95 mg/m2 in combination with 100 mg/m2 cisplatin intravenous bolus, and 2,800 mg/m2 5-FU continuous infusion and 2,000 mg/m2 leucovorin continuous infusion with prophylactic growth factors and antibiotics. Patients who achieved a complete (CR) or partial (PR) response to three cycles received definitive twice-daily radiation therapy. A total of 97 cycles were administered to 34 patients. The major acute toxicities were neutropenia and mucositis. The MTD of docetaxel was 90 mg/m2. Seventy-seven of 97 cycles of were administered on an outpatient basis. The overall clinical response rate to opTPFL was 94%, with 44% CRs and 50% PRs. The MTD of opTPFL is 90 mg/m2 docetaxel. Outpatient administration of opTPFL is tolerable, feasible, and does not alter the ability to administer definitive radiation therapy on schedule.

Original languageEnglish (US)
Pages (from-to)153-159
Number of pages7
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume25
Issue number2
DOIs
StatePublished - Apr 20 2002

Keywords

  • 5-FU
  • Cisplatin
  • Docetaxel
  • Head and neck
  • Induction chemotherapy
  • Squamous cell carcinoma

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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