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

NCT00625937 | Unknown Phase 2

• 2 other identifiers: CDR0000582621YONSEI-4-2006-021-0
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Objective response rate (complete or partial response) as assessed by RECIST criteria

Secondary Outcomes (3)

• Progression-free survival

• Overall survival

• Toxicity as assessed by NCI CTCAE v3.0 criteria

Interventions

cisplatin DRUG

docetaxel DRUG

tegafur-gimeracil-oteracil potassium DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei Cancer Center at Yonsei University Medical Center

Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Tongue Neoplasms

Interventions

Cisplatin; Docetaxel; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Tongue Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Therapeutics

Study Officials

• Joo-Hang Kim, MD

  Yonsei University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: February 29, 2008
• Study Start: November 1, 2006
• Primary Completion: November 1, 2010
• Last Updated: February 28, 2011

Record last verified: 2011-02

Locations

KR (1)