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

• Status: Terminated
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: Clinical Research Center for Solid Tumor, Korea
• Treatments: Docetaxel

Criteria

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