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International Journal of Clinical Oncology

, Volume 9, Issue 3, pp 161–166 | Cite as

Phase I trial of combined chemotherapy with docetaxel, cisplatin, and 5-fluorouracil for patients with locally advanced squamous cell carcinoma of the head and neck

  • Mamoru TsukudaEmail author
  • Yasukazu Mikami
  • Yuji Tanigaki
  • Hideaki Katori
  • Choichi Horiuchi
  • Yoichi Ikeda
  • Takahide Taguchi
  • Machiko Ono
  • Takahumi Yoshida
  • Yasunori Sakuma
  • Ken Aikoh
ORIGINAL ARTICLE

Background

This phase I study was designed to determine the maximum tolerated dose (MTD) and toxicities of combination chemotherapy with docetaxel, cisplatin, and 5-fluorouracil (5-FU) in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).

Methods

Patients received two cycles of chemotherapy repeated every 4 weeks. Starting doses (dose level 0) were: docetaxel 60 mg/m2, cisplatin 60 mg/m2, and 5-day continuous infusion 5-FU 600 mg/m2 per day. At least three patients were examined at each dose level before advancing to the next level.

Results

Nineteen male patients (median age, 59.5 years) were enrolled. Eighteen patients had previously untreated stage III or IV SCCHN and 1 had local relapse, rT4. In the 19 patients, the regimen was well tolerated, with neutropenia as the most common toxicity (grade 3; n = 11; grade 4; n = 1). Dose-limiting toxicity (DLT) was observed at the fifth dose level (docetaxel 70 mg/m2, cisplatin 70 mg/m2, 5-FU 750 mg/m2 per day), when 1 patient developed grade 2 renal toxicity during the first course; another 2 patients had persistent neutropenia. These doses were thus deemed the MTD for the regimen. In the 18 assessable patients, the overall clinical response rate was 94% (17/18 patients) and primary-site complete response (CR) occurred in 4 (22%) patients.

Conclusion

The MTD of this regimen was docetaxel 70 mg/m2 on day 1, cisplatin 70 mg/m2 on day 4, and 5-FU 750 mg/m2 per day for 5 days. The regimen was safe and generally well-tolerated and demonstrated good efficacy in patients with locally advanced SCCHN.

Key words

Head and neck carcinoma Docetaxel Cisplatin 5-Fluorouracil Combination chemotherapy 

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Copyright information

© Springer-Verlag Tokyo 2004

Authors and Affiliations

  • Mamoru Tsukuda
    • 1
    Email author
  • Yasukazu Mikami
    • 1
  • Yuji Tanigaki
    • 1
  • Hideaki Katori
    • 1
  • Choichi Horiuchi
    • 1
  • Yoichi Ikeda
    • 1
  • Takahide Taguchi
    • 1
  • Machiko Ono
    • 1
  • Takahumi Yoshida
    • 1
  • Yasunori Sakuma
    • 1
  • Ken Aikoh
    • 1
  1. 1.Department of OtolarygologyYokohama City University School of MedicineYokohamaJapan

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