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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00054054
First received: February 5, 2003
Last updated: July 21, 2011
Last verified: July 2011
  Purpose

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 Intervention Phase
Head and Neck Cancer
Drug: cisplatin
Drug: docetaxel
Drug: fluorouracil
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Study Start Date: April 2003
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054054

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

Additional Information:
Publications:
Adelstein DJ, Moon J, Hanna E, et al.: S0216: a Southwest Oncology Group (SWOG) phase II trial of docetaxel (T), cisplatin (P), and fluorouracil (F) induction followed by accelerated fractionation/concomitant boost (AF/CB) radiotherapy (RT) and concurrent cisplatin for advanced head and neck squamous cell cancer (HNSCC). [Abstract] J Clin Oncol 25 (Suppl 18): A-6014, 302s, 2007.

Responsible Party: Laurence H. Baker, D.O., Southwest Oncology Group-Group Chair's Office
ClinicalTrials.gov Identifier: NCT00054054     History of Changes
Other Study ID Numbers: CDR0000269781, S0216, U10CA032102
Study First Received: February 5, 2003
Last Updated: July 21, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:
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
Neoplasms by Site
Neoplasms
Docetaxel
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 26, 2014