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

Yonsei University

Status and phase: Unknown; Phase 2

Conditions: Head and Neck Cancer

Treatments: Radiation: radiation therapy; Drug: cisplatin; Drug: docetaxel; Drug: tegafur-gimeracil-oteracil potassium

Study type: Interventional

Funder types: Other

Identifiers

NCT00625937

CDR0000582621

YONSEI-4-2006-021-0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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