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Combination Chemotherapy in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
This study has been completed.
First Received: September 11, 2000   Last Updated: July 23, 2008   History of Changes
Sponsor: Southwest Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006248
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic or recurrent head and neck cancer.


Condition Intervention Phase
Head and Neck Cancer
Drug: cisplatin
Drug: fluorouracil
Drug: paclitaxel
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: Evaluation of Three Hour Infusion of Paclitaxel Plus Cisplatin and 5-Fluorouracil in Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 2000
Detailed Description:

OBJECTIVES:

  • Determine the overall survival of patients with metastatic or recurrent squamous cell carcinoma of the head and neck treated with paclitaxel, cisplatin, and fluorouracil.
  • Determine response (unconfirmed, confirmed, complete, and partial) and time to treatment failure in patients with measurable disease treated with this regimen.
  • Determine the toxic effects of this regimen in these patients.

OUTLINE: Patients receive paclitaxel IV over 3 hours followed by cisplatin IV over 30 minutes on day 1 and fluorouracil IV over 24 hours on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 3 additional courses beyond CR.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 12 months.

  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

    • Metastatic at diagnosis or persistent, metastatic, or recurrent after surgery and/or radiotherapy
    • Relapse after prior induction or adjuvant therapy allowed
  • No newly diagnosed nonmetastatic disease
  • Measurable or nonmeasurable disease

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Zubrod 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 50 mL/min

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No grade 2 or greater sensory neuropathy
  • 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 stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent biologic therapy

Chemotherapy:

  • See Disease Characteristics
  • At least 6 months since prior carboplatin or cisplatin induction or adjuvant chemotherapy
  • No more than 1 prior induction or adjuvant chemotherapy regimen
  • No prior chemotherapy for recurrent or newly diagnosed metastatic disease
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent anticancer hormonal therapy

Radiotherapy:

  • See Disease Characteristics
  • At least 28 days since prior radiotherapy and recovered
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics
  • At least 28 days since prior surgery and recovered
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006248

  Hide Study Locations
Locations
United States, Alabama
MBCCOP - Gulf Coast
Mobile, Alabama, United States, 36688
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
CCOP - Greater Phoenix
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
United States, Arkansas
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
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609-3305
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States, 95403
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
David Grant Medical Center
Travis Air Force Base, California, United States, 94535
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
University of California Davis Cancer Center
Sacramento, California, United States, 95817
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, United States, 94553
United States, Colorado
University of Colorado Cancer Center
Denver, 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, Georgia
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342-1701
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, United States, 30905-5650
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813-2424
Tripler Army Medical Center
Honolulu, Hawaii, United States, 96859-5000
United States, Illinois
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
Loyola University Medical Center
Maywood, Illinois, United States, 60153-5500
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States, 60612-7323
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States, 60612
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, United States, 60141
United States, Iowa
Genesis Medical Center
Davenport, Iowa, United States, 52804
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7353
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, United States, 67218
United States, Kentucky
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0084
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, United States, 40502-2236
United States, Louisiana
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, United States, 71130-3932
MBCCOP - LSU Medical Center
New Orleans, Louisiana, United States, 70112
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, United States, 71130
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, United States, 02130
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0912
CCOP - Beaumont
Royal Oak, Michigan, United States, 48073-6769
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Providence Hospital - Southfield
Southfield, Michigan, United States, 48075-9975
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States, 48106
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, United States, 48105
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States, 48201-1932
United States, Mississippi
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, United States, 39534-2576
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, United States, 39531-2410
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, United States, 39216
United States, Missouri
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
CCOP - St. Louis-Cape Girardeau
Saint Louis, Missouri, United States, 63141
St. Louis University Health Sciences Center
Saint Louis, Missouri, United States, 63110
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, United States, 64128
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
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
New York, New York, United States, 10032
University of Rochester Medical Center
Rochester, New York, United States, 14642
Veterans Affairs Medical Center - Albany
Albany, New York, United States, 12208
United States, North Carolina
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
Barrett Cancer Center
Cincinnati, Ohio, United States, 45267-0501
CCOP - Columbus
Columbus, Ohio, United States, 43206
CCOP - Dayton
Dayton, Ohio, United States, 45429
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195-9001
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
CCOP - Columbia River Program
Portland, Oregon, United States, 97225
Oregon Cancer Institute
Portland, Oregon, United States, 97239
Veterans Affairs Medical Center - Portland
Portland, Oregon, United States, 97207
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-0721
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, United States, 29401-5799
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234-6200
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7845
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0565
Veterans Affairs Medical Center - Houston
Houston, Texas, United States, 77030
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States, 78284
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, Virginia
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23510-1115
United States, Washington
CCOP - Northwest
Tacoma, Washington, United States, 98405-0986
CCOP - Virginia Mason Research Center
Seattle, Washington, United States, 98101
Madigan Army Medical Center
Tacoma, Washington, United States, 98431-5000
Veterans Affairs Medical Center - Seattle
Seattle, Washington, United States, 98108
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Maha Hadi A. Hussain, MD University of Michigan Cancer Center
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000068180, SWOG-S0007
Study First Received: September 11, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00006248     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV squamous cell carcinoma of the lip and oral cavity
recurrent squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the nasopharynx
recurrent squamous cell carcinoma of the nasopharynx
stage IV squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the larynx
recurrent squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms by Site
Cisplatin
Therapeutic Uses
Neoplasms, Squamous Cell
Neoplasms by Histologic Type
Mitosis Modulators
Antimitotic Agents
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Paclitaxel
Fluorouracil
Head and Neck Neoplasms
Tubulin Modulators
Carcinoma, Squamous Cell
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009