RATIONALE: Radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining high-dose radiation with chemotherapy may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of combining high-dose radiation therapy with chemotherapy in treating patients who have newly diagnosed stage II, stage III, or stage IV nasopharyngeal cancer.

Condition	Treatment or Intervention	Phase
stage II lymphoepithelioma of the nasopharynx stage II squamous cell carcinoma of the nasopharynx 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	Drug: cisplatin  Drug: fluorouracil  Procedure: adjuvant therapy  Procedure: chemotherapy  Procedure: radiation therapy	Phase I Phase II

Further Study Details: 

OBJECTIVES:

• Determine the feasibility of dose-painting using accelerated fractionation intensity modulated radiotherapy with chemotherapy in patients with stage II-IVB nasopharyngeal cancer.
• Determine the toxicity, including xerostomia and ototoxicity, of this regimen in these patients.
• Determine the rates of local-regional control and survival of patients treated with this regimen.

OUTLINE: Cohorts of 10 patients receive the following treatment to assess for dose-limiting toxicity.

Phase I

• Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.
• Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.
• Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II.

Phase II

• Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 10-74 patients (10-20 for phase I and 54 for phase II) will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed nasopharyngeal cancer
• Stage II-IVB
• Newly diagnosed
• No distant metastases

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• Not specified

Hematopoietic

• WBC at least 3,000/mm^3
• Granulocyte count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 8 g/dL

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase no greater than 2.5 times ULN
• AST no greater than 2.5 times ULN

Renal

• Creatinine no greater than 1.5 mg/dL
• Creatinine clearance at least 60 mL/min
• Calcium no greater than 11.5 mg/dL

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Medically able to tolerate a definitive course of radiotherapy and the necessary immobilization
• No other active malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for this diagnosis
• More than 3 years since other prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy for this diagnosis
• More than 3 years since other prior radiotherapy
• No prior radiotherapy to the head and neck region

Surgery

• Not specified

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting

Study chairs or principal investigators

Suzanne Wolden, MD,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  CDR0000258423; MSKCC-02077; NCI-H02-0101; NCT00052429
Record last reviewed:  December 2002
Last Updated:  February 4, 2005
Record first received:  January 24, 2003
ClinicalTrials.gov Identifier:  NCT00052429
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08