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
Conditions
Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage III verrucous carcinoma of the oral cavity, stage IV verrucous carcinoma of the oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage III lymphoepithelioma of the nasopharynx, stage III squamous cell carcinoma of the nasopharynx, stage IV lymphoepithelioma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, stage III lymphoepithelioma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage IV lymphoepithelioma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, tongue cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: cisplatin Type: Drug
Name: docetaxel Type: Drug
Name: tegafur-gimeracil-oteracil potassium Type: Drug
Name: radiation therapy Type: Radiation
Overall Status
Recruiting
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.
Detailed Description
OBJECTIVES:

Primary

- To assess the response rate in patients with stage III or IV head and neck cancer treated with induction therapy comprising docetaxel and S-1 followed by radiotherapy and low-dose cisplatin.

Secondary

- To assess the effect of this regimen on survival and locoregional and systemic control rates in these patients.

OUTLINE:

- Induction chemotherapy: Patients receive oral S-1 twice daily on days 1-14 and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

- Chemoradiotherapy: Patients receive low-dose cisplatin IV once daily and undergo radiotherapy 5 days a week for 7 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically for 18 months.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Location
Yonsei Cancer Center at Yonsei University Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: Joo-Hang Kim, MD - 82-2-2228-8131 - kjhang@yuhs.ac
Start Date
November 2006
Sponsors
Yonsei University
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page