Docetaxel and S-1 Followed By Radiation Therapy and Low-Dose Cisplatin in Treating Patients With Stage III or Stage IV Head and Neck Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, S-1, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel and S-1 together with radiation therapy and low-dose cisplatin works in treating patients with stage III or stage IV head and neck cancer.

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

Details

• Lead Sponsor: Yonsei University
• Treatments: Cisplatin; Docetaxel; Tegafur

Criteria

DISEASE CHARACTERISTICS:

• Pathologically confirmed head and neck cancer arising from the oral cavity, oropharynx, hypopharynx, or nasopharynx, including any of the following subtypes:

• Squamous cell carcinoma

• Poorly differentiated carcinoma

• Lymphoepithelioma

• Locally advanced disease (stage III or IV [M0] disease)

• At least 1 unidimensionally measurable index lesion

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• ANC ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Hemoglobin ≥ 9 g/dL

• Bilirubin ≤ 1.5 times the upper limit of normal (ULN)

• Alkaline phosphatase ≤ 3.0 times ULN

• AST and ALT ≤ 3.0 times ULN

• Creatinine ≤ 1.5 times ULN

• No concurrent serious systemic disorder that, in the opinion of investigator, would compromise the patient's ability to complete the study

• No serious cardiac condition, including any of the following:

• Myocardial infarction within the past 6 months

• Angina

• NYHA class III-IV heart disease

• No active infection requiring IV antibiotics, including active tuberculosis or HIV

• No other malignancy within the past 5 years except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix

• Able to comply with protocol or study procedures

PRIOR CONCURRENT THERAPY:

• No prior radiotherapy or chemotherapy