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S0216, Combination Chemotherapy and RT in Treating Patients With Stage III or Stage IV Head and Neck Cancer

Sponsor
Southwest Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00054054
Collaborator
National Cancer Institute (NCI) (NIH)
95
Locations

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
Docetaxel (NSC-628503), Cisplatin (NSC-119875), And 5-Fluorouracil (NSC-19893) Induction Chemotherapy Followed By Accelerated Fractionation/Concomitant Boost Radiation And Concurrent Single Agent Cisplatin (NSC-119875), In Patients With Advanced Squamous Cell Head And Neck Cancer
Study Start Date :
Apr 1, 2003
Actual Primary Completion Date :
Nov 1, 2007

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Comprehensive Cancer Center Birmingham Alabama United States 35294-3300
    2 MBCCOP - Gulf Coast Mobile Alabama United States 36607
    3 CCOP - Western Regional, Arizona Phoenix Arizona United States 85006-2726
    4 Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) Phoenix Arizona United States 85012
    5 Veterans Affairs Medical Center - Tucson Tucson Arizona United States 85723
    6 Arizona Cancer Center at University of Arizona Health Sciences Center Tucson Arizona United States 85724
    7 Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    8 Veterans Affairs Medical Center - Little Rock (McClellan) Little Rock Arkansas United States 72205
    9 City of Hope Comprehensive Cancer Center Duarte California United States 91010-3000
    10 California Cancer Center Fresno California United States 93720
    11 USC/Norris Comprehensive Cancer Center and Hospital Los Angeles California United States 90033
    12 Veterans Affairs Outpatient Clinic - Martinez Martinez California United States 94553
    13 CCOP - Bay Area Tumor Institute Oakland California United States 94609-3305
    14 Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center Orange California United States 92868
    15 University of California Davis Cancer Center Sacramento California United States 95817
    16 CCOP - Santa Rosa Memorial Hospital Santa Rosa California United States 95403
    17 David Grant Medical Center Travis Air Force Base California United States 94535
    18 University of Colorado Cancer Center at University of Colorado Health Sciences Center Aurora Colorado United States 80010
    19 Veterans Affairs Medical Center - Denver Denver Colorado United States 80220
    20 MBCCOP - Howard University Cancer Center Washington District of Columbia United States 20060
    21 Veterans Affairs Medical Center - Tampa (Haley) Tampa Florida United States 33612
    22 CCOP - Atlanta Regional Atlanta Georgia United States 30342-1701
    23 MBCCOP - Hawaii Honolulu Hawaii United States 96813
    24 MBCCOP - University of Illinois at Chicago Chicago Illinois United States 60612
    25 Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago Illinois United States 60612
    26 CCOP - Central Illinois Decatur Illinois United States 62526
    27 Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) Hines Illinois United States 60141
    28 Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood Illinois United States 60153-5500
    29 Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Kansas City Kansas United States 66160-7353
    30 CCOP - Wichita Wichita Kansas United States 67214-3882
    31 Veterans Affairs Medical Center - Wichita Wichita Kansas United States 67218
    32 Veterans Affairs Medical Center - Lexington Lexington Kentucky United States 40502-2236
    33 Markey Cancer Center at University of Kentucky Chandler Medical Center Lexington Kentucky United States 40536-0084
    34 MBCCOP - LSU Health Sciences Center New Orleans Louisiana United States 70112
    35 Tulane Cancer Center at Tulane University Hospital and Clinic New Orleans Louisiana United States 70112
    36 Veterans Affairs Medical Center - New Orleans New Orleans Louisiana United States 70112
    37 Veterans Affairs Medical Center - Shreveport Shreveport Louisiana United States 71101-4295
    38 Louisiana State University Health Sciences Center - Shreveport Shreveport Louisiana United States 71130-3932
    39 Cancer Research Center at Boston Medical Center Boston Massachusetts United States 02118
    40 Veterans Affairs Medical Center - Ann Arbor Ann Arbor Michigan United States 48105
    41 CCOP - Michigan Cancer Research Consortium Ann Arbor Michigan United States 48106
    42 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109-0912
    43 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201-1379
    44 Veterans Affairs Medical Center - Detroit Detroit Michigan United States 48201-1932
    45 Josephine Ford Cancer Center at Henry Ford Hospital Detroit Michigan United States 48202
    46 CCOP - Grand Rapids Grand Rapids Michigan United States 49503
    47 CCOP - Beaumont Royal Oak Michigan United States 48073-6769
    48 Providence Cancer Institute at Providence Hospital Southfield Michigan United States 48075
    49 University of Mississippi Medical Center Jackson Mississippi United States 39216-4505
    50 Veterans Affairs Medical Center - Jackson Jackson Mississippi United States 39216
    51 CCOP - Kansas City Kansas City Missouri United States 64131
    52 St. Louis University Hospital Cancer Center Saint Louis Missouri United States 63110
    53 CCOP - St. Louis-Cape Girardeau Saint Louis Missouri United States 63141
    54 CCOP - Cancer Research for the Ozarks Springfield Missouri United States 65807
    55 CCOP - Montana Cancer Consortium Billings Montana United States 59101
    56 Veterans Affairs Medical Center - East Orange East Orange New Jersey United States 07018-1095
    57 Veterans Affairs Medical Center - Albuquerque Albuquerque New Mexico United States 87108-5138
    58 MBCCOP - University of New Mexico HSC Albuquerque New Mexico United States 87131
    59 NYU School of Medicine's Kaplan Comprehensive Cancer Center New York New York United States 10016
    60 Herbert Irving Comprehensive Cancer Center at Columbia University New York New York United States 10032
    61 James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester New York United States 14642
    62 Veterans Affairs Medical Center - Salisbury Salisbury North Carolina United States 28144
    63 CCOP - Southeast Cancer Control Consortium Winston-Salem North Carolina United States 27104-4241
    64 Veterans Affairs Medical Center - Cincinnati Cincinnati Ohio United States 45220-2288
    65 Charles M. Barrett Cancer Center at University Hospital Cincinnati Ohio United States 45267-0501
    66 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195-9001
    67 CCOP - Columbus Columbus Ohio United States 43206
    68 Veterans Affairs Medical Center - Dayton Dayton Ohio United States 45428-1002
    69 CCOP - Dayton Dayton Ohio United States 45429
    70 Cancer Institute at Oregon Health and Science University Portland Oregon United States 97201-3098
    71 Veterans Affairs Medical Center - Portland Portland Oregon United States 97207
    72 CCOP - Columbia River Oncology Program Portland Oregon United States 97225
    73 Veterans Affairs Medical Center - Charleston Charleston South Carolina United States 29401-5799
    74 Hollings Cancer Center at Medical University of South Carolina Charleston South Carolina United States 29425
    75 CCOP - Greenville Greenville South Carolina United States 29615
    76 CCOP - Upstate Carolina Spartanburg South Carolina United States 29303
    77 University of Tennessee Cancer Institute Memphis Tennessee United States 38104
    78 Harrington Cancer Center Amarillo Texas United States 79106
    79 Veterans Affairs Medical Center - Amarillo Amarillo Texas United States 79106
    80 Brooke Army Medical Center Fort Sam Houston Texas United States 78234-6200
    81 University of Texas Medical Branch Galveston Texas United States 77555-0565
    82 University of Texas - MD Anderson Cancer Center Houston Texas United States 77030-4095
    83 Veterans Affairs Medical Center - Houston Houston Texas United States 77030
    84 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229-3900
    85 Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio Texas United States 78229
    86 Veterans Affairs Medical Center - Temple Temple Texas United States 76504
    87 CCOP - Scott and White Hospital Temple Texas United States 76508
    88 Huntsman Cancer Institute Salt Lake City Utah United States 84112-5550
    89 Veterans Affairs Medical Center - Salt Lake City Salt Lake City Utah United States 84148
    90 CCOP - Virginia Mason Research Center Seattle Washington United States 98101
    91 Veterans Affairs Medical Center - Seattle Seattle Washington United States 98108
    92 Puget Sound Oncology Consortium Seattle Washington United States 98109
    93 CCOP - Northwest Tacoma Washington United States 98405-0986
    94 Madigan Army Medical Center Tacoma Washington United States 98431-5000
    95 Hospital for Sick Children Toronto Ontario Canada M5G 1X8

    Sponsors and Collaborators

    • Southwest Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: David J. Adelstein, MD, The Cleveland Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00054054
    Other Study ID Numbers:
    • CDR0000269781
    • S0216
    • U10CA032102
    First Posted:
    Feb 6, 2003
    Last Update Posted:
    Jul 25, 2011
    Last Verified:
    Jul 1, 2011
    Keywords provided by , ,
    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
    Additional relevant MeSH terms:
    Head and Neck Neoplasms
    Docetaxel
    Fluorouracil

    Study Results

    No Results Posted as of Jul 25, 2011