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

NCT ID: NCT00625937

Last Updated: 2011-02-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30

Brief 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.

Conditions

Head and Neck Cancer

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 Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

cisplatin

Intervention Type: DRUG

docetaxel

Intervention Type: DRUG

tegafur-gimeracil-oteracil potassium

Intervention Type: DRUG

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Principal Investigators

Joo-Hang Kim, MD

Role: STUDY_CHAIR

Yonsei University

Locations

Yonsei Cancer Center at Yonsei University Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

Joo-Hang Kim, MD

Role: primary

Other Identifiers

YONSEI-4-2006-021-0

Identifier Type: -

Identifier Source: secondary_id

CDR0000582621

Identifier Type: -

Identifier Source: org_study_id