RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients with head and neck cancer.

Condition	Treatment or Intervention	Phase
Gastrointestinal Cancer Neck Cancer Oral Cancer Throat Cancer	Drug: fluorouracil  Drug: hydroxyurea  Procedure: chemotherapy  Procedure: radiation therapy  Procedure: surgery	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the locoregional control rates, time to failure, need for salvage surgery and overall survival of patients with intermediate stage cancer of the oral cavity, pharynx, larynx, paranasal sinuses, and cervical esophagus.
• Measure the impact of concomitant Hyper-FHX radiotherapy on organ preservation, organ function and quality of life parameters.
• Identify possible prognostic factors for toxic effects and response by performing pharmacologic monitoring.

OUTLINE: Patients receive concomitant chemoradiotherapy with curative intent. Patients who have microscopic or macroscopic residual disease 6 weeks after completion of chemoradiotherapy will receive a surgical salvage procedure.

The first cycle of chemotherapy will begin with PO doses of hydroxyurea every 12 hours on days 0-5. Fluorouracil is given IV on days 0-4. Radiation therapy BID is given on days 1-6. Cycles repeat every 14 days for a total of 5 cycles.

The disease will be reevaluated 4-6 weeks after completion of all treatment, every 3 months for 1 year, then yearly.

PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.

Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed diagnosis of carcinoma
• Stage II-III (T2, T3, N0 or T1-3, N1) carcinoma of head and neck, including: oral cavity, pharynx, larynx, paranasal sinuses, and cervical esophagus
• No N2 or N3
• Measurable disease is not required

PATIENT CHARACTERISTICS: Age:

• Not specified

Performance status:

• Zubrod 0-3

Life expectancy:

• Anticipated survival is 3-4 years (median)

Hematopoietic:

• WBC count at least 3.5/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Not specified

Renal:

• Not specified

Cardiovascular:

• Not specified

Pulmonary:

• Not specified

Other:

• No infection or severe medical illness
• Not pregnant

PRIOR CONCURRENT THERAPY: Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy

Surgery:

• No prior surgery

Illinois
      CCOP - Evanston, Evanston,  Illinois,  60201,  United States
      Louis A. Weiss Memorial Hospital, Chicago,  Illinois,  60640,  United States
      Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago,  Illinois,  60611-3013,  United States
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States

Study chairs or principal investigators

Everett E. Vokes, MD,  Study Chair,  University of Chicago Cancer Research Center   

Study ID Numbers:  CDR0000065421; UCCRC-8176; NU-V96N1; NCI-G97-1159
Record last reviewed:  May 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002951
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08