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 more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients with stage III or stage IV head and neck cancer.

Condition	Treatment or Intervention	Phase
stage III squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the larynx stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the oropharynx	Drug: cisplatin  Drug: docetaxel  Drug: fluorouracil  Procedure: chemotherapy  Procedure: radiation therapy  Procedure: radiosensitization	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the overall survival of patients with stage III or IV squamous cell head and neck cancer treated with docetaxel, cisplatin, and fluorouracil followed by accelerated fractionation/concomitant boost radiotherapy and cisplatin.
• Determine the unconfirmed complete response rate in these patients after treatment with induction chemotherapy.
• Determine the overall complete response rate (confirmed and unconfirmed) in patients treated with this regimen.
• Determine the toxic effects of this regimen in these patients.

OUTLINE:

• Induction Chemotherapy: Patients receive docetaxel IV over 1 hour and cisplatin IV over 30-60 minutes on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity.
• Chemoradiotherapy: Beginning within 3-4 weeks after administration of the second course of induction chemotherapy, patients receive accelerated fractionation radiotherapy once daily, 5 days per week, for 6 weeks with concomitant boost radiotherapy once daily, 5 days a week, for the last 2.5 weeks of radiotherapy. Patients also receive concurrent cisplatin IV over 30-60 minutes on days 1 and 22. Patients are followed every 2 months for 1 year, every 3 months for 2 years, every 4 months for 1 year, and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 2 years.

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

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed squamous cell carcinoma of the head and neck (excluding lip, nasopharynx, paranasal sinus, and salivary gland) by biopsy or fine needle aspirate of the primary lesion or neck mass
• Stage III or IV disease
• No evidence of distant metastases
• Negative chest x-ray
• Primary site in the head and neck region must be identified
• No unknown primary site
• Considered to be appropriate for definitive radiotherapy with curative intent

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Granulocyte count greater than 1,500/mm^3
• Platelet count greater than 100,000/mm^3

Hepatic

• Bilirubin no greater than upper limit of normal (ULN)
• Alkaline phosphatase less than 2 times ULN
• ALT or AST less than 1.5 times ULN

Renal

• Creatinine less than 1.5 mg/dL

Cardiovascular

• No myocardial infarction within the past 3 months
• No unstable or uncontrolled angina

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
• No evidence of pre-existing peripheral neuropathy
• No active systemic infection
• No history of hypersensitivity reaction to products containing polysorbate 80

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• No prior radiotherapy

Surgery

• No prior surgery for head or neck cancer

Alabama
      MBCCOP - Gulf Coast, Mobile,  Alabama,  36607,  United States
      University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham,  Alabama,  35294-3300,  United States
Arizona
      Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson,  Arizona,  85724,  United States
      CCOP - Western Regional, Arizona, Phoenix,  Arizona,  85006-2726,  United States
      Veterans Affairs Medical Center - Phoenix (Carl T. Hayden), Phoenix,  Arizona,  85012,  United States
      Veterans Affairs Medical Center - Tucson, Tucson,  Arizona,  85723,  United States
Arkansas
      Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock,  Arkansas,  72205,  United States
      Veterans Affairs Medical Center - Little Rock (McClellan), Little Rock,  Arkansas,  72205,  United States
California
      California Cancer Center, Fresno,  California,  93720,  United States
      CCOP - Bay Area Tumor Institute, Oakland,  California,  94609-3305,  United States
      CCOP - Santa Rosa Memorial Hospital, Santa Rosa,  California,  95403,  United States
      Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center, Orange,  California,  92868,  United States
      City of Hope Comprehensive Cancer Center, Duarte,  California,  91010-3000,  United States
      David Grant Medical Center, Travis Air Force Base,  California,  94535,  United States
      University of California Davis Cancer Center, Sacramento,  California,  95817,  United States
      USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles,  California,  90033,  United States
      Veterans Affairs Outpatient Clinic - Martinez, Martinez,  California,  94553,  United States
Colorado
      University of Colorado Cancer Center at University of Colorado Health Sciences Center, Aurora,  Colorado,  80010,  United States
      Veterans Affairs Medical Center - Denver, Denver,  Colorado,  80220,  United States
District of Columbia
      MBCCOP - Howard University Cancer Center, Washington,  District of Columbia,  20060,  United States
Florida
      Veterans Affairs Medical Center - Tampa (Haley), Tampa,  Florida,  33612,  United States
Georgia
      CCOP - Atlanta Regional, Atlanta,  Georgia,  30342-1701,  United States
Hawaii
      MBCCOP - Hawaii, Honolulu,  Hawaii,  96813,  United States
Illinois
      Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood,  Illinois,  60153-5500,  United States
      CCOP - Central Illinois, Decatur,  Illinois,  62526,  United States
      MBCCOP - University of Illinois at Chicago, Chicago,  Illinois,  60612,  United States
      Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago,  Illinois,  60612,  United States
      Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital), Hines,  Illinois,  60141,  United States
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States
      Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City,  Kansas,  66160-7353,  United States
      Veterans Affairs Medical Center - Wichita, Wichita,  Kansas,  67218,  United States
Kentucky
      Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington,  Kentucky,  40536-0084,  United States
      Veterans Affairs Medical Center - Lexington, Lexington,  Kentucky,  40502-2236,  United States
Louisiana
      Louisiana State University Health Sciences Center - Shreveport, Shreveport,  Louisiana,  71130-3932,  United States
      MBCCOP - LSU Health Sciences Center, New Orleans,  Louisiana,  70112,  United States
      Tulane Cancer Center at Tulane University Hospital and Clinic, New Orleans,  Louisiana,  70112,  United States
      Veterans Affairs Medical Center - New Orleans, New Orleans,  Louisiana,  70112,  United States
      Veterans Affairs Medical Center - Shreveport, Shreveport,  Louisiana,  71101-4295,  United States
Massachusetts
      Cancer Research Center at Boston Medical Center, Boston,  Massachusetts,  02118,  United States
Michigan
      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201-1379,  United States
      CCOP - Beaumont, Royal Oak,  Michigan,  48073-6769,  United States
      CCOP - Grand Rapids, Grand Rapids,  Michigan,  49503,  United States
      CCOP - Michigan Cancer Research Consortium, Ann Arbor,  Michigan,  48106,  United States
      Josephine Ford Cancer Center at Henry Ford Hospital, Detroit,  Michigan,  48202,  United States
      Providence Cancer Institute at Providence Hospital, Southfield,  Michigan,  48075,  United States
      University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109-0912,  United States
      Veterans Affairs Medical Center - Ann Arbor, Ann Arbor,  Michigan,  48105,  United States
      Veterans Affairs Medical Center - Detroit, Detroit,  Michigan,  48201-1932,  United States
Mississippi
      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States
      Veterans Affairs Medical Center - Jackson, Jackson,  Mississippi,  39216,  United States
Missouri
      CCOP - Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States
      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States
      CCOP - St. Louis-Cape Girardeau, Saint Louis,  Missouri,  63141,  United States
      St. Louis University Hospital Cancer Center, Saint Louis,  Missouri,  63110,  United States
Montana
      CCOP - Montana Cancer Consortium, Billings,  Montana,  59101,  United States
New Jersey
      Veterans Affairs Medical Center - East Orange, East Orange,  New Jersey,  07018-1095,  United States
New Mexico
      MBCCOP - University of New Mexico HSC, Albuquerque,  New Mexico,  87131,  United States
      Veterans Affairs Medical Center - Albuquerque, Albuquerque,  New Mexico,  87108-5138,  United States
New York
      Herbert Irving Comprehensive Cancer Center at Columbia University, New York,  New York,  10032,  United States
      James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester,  New York,  14642,  United States
      NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York,  New York,  10016,  United States
North Carolina
      CCOP - Southeast Cancer Control Consortium, Winston Salem,  North Carolina,  27104-4241,  United States
      Veterans Affairs Medical Center - Salisbury, Salisbury,  North Carolina,  28144,  United States
Ohio
      CCOP - Columbus, Columbus,  Ohio,  43206,  United States
      CCOP - Dayton, Dayton,  Ohio,  45429,  United States
      Charles M. Barrett Cancer Center at University Hospital, Cincinnati,  Ohio,  45267-0501,  United States
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195-9001,  United States
      Veterans Affairs Medical Center - Cincinnati, Cincinnati,  Ohio,  45220-2288,  United States
      Veterans Affairs Medical Center - Dayton, Dayton,  Ohio,  45428-1002,  United States
Oregon
      Cancer Institute at Oregon Health and Science University, Portland,  Oregon,  97201-3098,  United States
      CCOP - Columbia River Oncology Program, Portland,  Oregon,  97225,  United States
      Veterans Affairs Medical Center - Portland, Portland,  Oregon,  97207,  United States
South Carolina
      CCOP - Greenville, Greenville,  South Carolina,  29615,  United States
      CCOP - Upstate Carolina, Spartanburg,  South Carolina,  29303,  United States
      Hollings Cancer Center at Medical University of South Carolina, Charleston,  South Carolina,  29425,  United States
      Veterans Affairs Medical Center - Charleston, Charleston,  South Carolina,  29401-5799,  United States
Tennessee
      University of Tennessee Cancer Institute, Memphis,  Tennessee,  38104,  United States
Texas
      Brooke Army Medical Center, Fort Sam Houston,  Texas,  78234-6200,  United States
      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States
      Harrington Cancer Center, Amarillo,  Texas,  79106,  United States
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4095,  United States
      University of Texas Health Science Center at San Antonio, San Antonio,  Texas,  78229-3900,  United States
      University of Texas Medical Branch, Galveston,  Texas,  77555-0565,  United States
      Veterans Affairs Medical Center - Amarillo, Amarillo,  Texas,  79106,  United States
      Veterans Affairs Medical Center - Houston, Houston,  Texas,  77030,  United States
      Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio,  Texas,  78229,  United States
      Veterans Affairs Medical Center - Temple, Temple,  Texas,  76504,  United States
Utah
      Huntsman Cancer Institute, Salt Lake City,  Utah,  84112-5550,  United States
      Veterans Affairs Medical Center - Salt Lake City, Salt Lake City,  Utah,  84148,  United States
Washington
      CCOP - Northwest, Tacoma,  Washington,  98405-0986,  United States
      CCOP - Virginia Mason Research Center, Seattle,  Washington,  98101,  United States
      Madigan Army Medical Center, Tacoma,  Washington,  98431-5000,  United States
      Puget Sound Oncology Consortium, Seattle,  Washington,  98109,  United States
      Veterans Affairs Medical Center - Seattle, Seattle,  Washington,  98108,  United States
Canada, Ontario
      Hospital for Sick Children, Toronto,  Ontario,  M5G 1X8,  Canada

Study chairs or principal investigators

David J. Adelstein, MD,  Study Chair,  Cleveland Clinic Cancer Center   

Study ID Numbers:  CDR0000269781; SWOG-S0216
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  February 5, 2003
ClinicalTrials.gov Identifier:  NCT00054054
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08