Docetaxel and S-1 in Head and Neck Squamous Cell Carcinoma (HNSCC)

Overview

To assess response rate of docetaxel and S-1 combination in metastatic or recurrent head and neck squamous cell carcinoma

Full Title of Study: “A Randomized, Multicenter, Phase II Study of Docetaxel and TS-1 Combination as a First-line Treatment in Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: July 2011

Interventions

• Drug: docetaxel+CDDP
  • docetaxel+CDDP
• Drug: docetaxel+S-1
  • docetaxel+S-1

Arms, Groups and Cohorts

• Active Comparator: 1
  • docetaxel+CDDP
• Experimental: 2
  • docetaxel+S-1

Clinical Trial Outcome Measures

Primary Measures

• Response rate

Secondary Measures

• progression-free survival
• duration of response
• overall survival
• safety

Participating in This Clinical Trial

Inclusion Criteria

• histologically confirmed HNSCC
• adequate primary site: oral cavity, oropharynx, hypopharynx, nasal cavity, paranasal sinus, other head and neck site (except nasopharynx)
• at least one measurable lesion
• no previous palliative chemotherapy (adjuvant/neoadjuvant chemotherapy and/or radiotherapy longer than 6 months ago is permitted)
• 18 years or older
• ECOG 0 or 1
• adequate laboratory result
• written, informed consent

Exclusion Criteria

• pregnant or lactating women (negative pregnancy test within 7 days is required for women with potential of child-bearing)
• experimental drug clinical trial within 30 days
• other malignancy (exemption: treated basal cell carcinoma of skin, CIS, cured cancer with disease-free interval with more than 5 years)
• patient with organ transplantation
• grade 2 or more peripheral neuropathy
• grade 2 or more hearing loss
• severe, medical condition

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Seoul National University Hospital
• Collaborator
  • Clinical Research Center for Solid Tumor, Korea
• Provider of Information About this Clinical Study
  • Dae-Seog Heo, Professor, Clinical Research Center for Solid Tumor, Korea