Study of escalating doses of paclitaxel plus cisplatin in patients with inoperable head and neck cancer Academic Article uri icon


MeSH Major

  • Antineoplastic Combined Chemotherapy Protocols
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Paclitaxel


  • This phase I/II study sought to determine the response rate and toxicity profile of escalating doses of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) when administered with fixed doses of cisplatin with granulocyte colony-stimulating factor support in 28 patients with head or neck cancer. The study was designed as a modified dose-finding trial and contained five dose-escalation levels of paclitaxel. Dose level 1 contained seven patients, and doses ranged from 175 to 220 mg/m2; dose level 2, 230 to 250 mg/m2 (five patients); dose level 3, 250 mg/m2 only (four patients); dose level 4, 260 to 280 mg/m2 (six patients); and dose level 5, 280 to 300 mg/m2 (six patients). Dose levels greater than 200 mg/m2 were supported with concomitant granulocyte colony-stimulating support. Paclitaxel was given on day 1 by 3-hour infusion; cisplatin 75 mg/m2 was given on day 2. Courses were given every 3 weeks. All patients were evaluable for toxicity and 27 were evaluable for response. The overall response rate was 77% (10 complete responses, 11 partial responses, four no change, and two disease progression). Over a median follow-up of 15 months (range, 7 to 22 months), 16 patients showed no evidence of disease and three are alive with disease. A dose-effect relationship was found between paclitaxel and peripheral neuropathy. Twenty-seven of 28 patients experienced alopecia, peripheral neuropathy, myalgias, and arthralgias. Most toxicities were grade 1 or 2; the mean duration of symptoms was 7 days. No dose-limiting hematologic toxicity was observed, nor was any significant neutropenia seen in those patients receiving filgrastim. The paclitaxel/cisplatin combination was found to be an effective first-line regimen for patients with head or neck cancer. Although the number of patients in this study was small, no relationship was noted between patient response and disease site.

publication date

  • March 22, 1997



  • Academic Article



  • eng

PubMed ID

  • 9045339

Additional Document Info

start page

  • S2

end page

  • 58-S2-64


  • 24


  • 1 SUPPL. 2