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

Head and Neck Cancer Clinical Trial

Official title:

A Phase ll Trial of Induction Docetaxel and S-1 Followed by Concomitant Radiotherapy With Low-dose Daily Cisplatin in Locally Advanced Head and Neck Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00625937
• Other study ID #: CDR0000582621
• Secondary ID: YONSEI-4-2006-02
• Status: Recruiting
• Phase: Phase 2
• First received: February 28, 2008
• Last updated: February 25, 2011
• Start date: November 2006

Study information

• Verified date: February 2011
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• cisplatin

• docetaxel

• tegafur-gimeracil-oteracil potassium

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Korea, Republic of	Yonsei Cancer Center at Yonsei University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (complete or partial response) as assessed by RECIST criteria			No
Secondary	Progression-free survival			No
Secondary	Overall survival			No
Secondary	Toxicity as assessed by NCI CTCAE v3.0 criteria			Yes