Combination Chemotherapy in Treating Patients With Advanced Head and Neck Cancer

Last updated: June 20, 2013
Sponsor: Eastern Cooperative Oncology Group
Overall Status: Completed

Phase

3

Condition

Head And Neck Cancer

Nasopharyngeal Cancer

Human Papilloma Virus (Hpv)

Treatment

N/A

Clinical Study ID

NCT00002888
CDR0000065210
SWOG-E1395
E-1395
  • Ages > 18
  • All Genders

Study Summary

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. It is not yet known whether cisplatin plus fluorouracil are more effective than paclitaxel plus cisplatin in treating patients with advanced head and neck cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients with advanced head and neck cancer.

Eligibility Criteria

Inclusion

DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the head and neck considered incurable by surgery or radiotherapy Newly diagnosed extensive locoregional disease or distant metastases Locoregionally recurrent or persistent disease, or distant metastases occurring after initial surgery or radiotherapy No nasopharyngeal carcinoma No history of brain metastases Measurable or evaluable disease Documented progressive disease or biopsy-proven residual carcinoma required if sole measurable site previously irradiated

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Hematopoietic: ANC at least 1,500/mm3 Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic: Bilirubin less than 1.5 mg/dL AST/ALT no greater than twice normal Alkaline phosphatase no greater than twice normal Renal: Creatinine no greater than 1.2 mg/dL OR Creatinine clearance at least 50 mL/min Calcium normal No history of hypercalcemia Cardiovascular: No congestive heart failure No serious arrhythmia requiring medication No myocardial infarction within 6 months No medications known to alter cardiac conduction (i.e., lanoxin, beta or calcium channel blockers) Other: No significant detectable or occult infection Complete evaluation required if elevated WBC (12,000 or greater) or fever (101.6 F or higher) No hypersensitivity to E. coli-derived proteins No allergy to drugs utilizing Cremophor No other malignancy within 3 years except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix Not pregnant Negative pregnancy test Fertile patients must use effective contraception Must complete quality of life and pain assessments at required intervals

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for recurrent disease At least 12 months since induction or neoadjuvant chemotherapy with paclitaxel or fluorouracil (6 months since cisplatin) Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: Recovered from major surgery

Study Design

Study Start date:
March 01, 1997
Estimated Completion Date:
August 31, 2004

Study Description

OBJECTIVES: I. Compare the response rate, toxicity, quality-of-life, and overall survival at 1 year in patients with advanced head and neck carcinomas when treated with paclitaxel and cisplatin vs cisplatin and fluorouracil. II. Compare these regimens in terms of quality of life and correlate quality of life to toxicity in these patients. III. Compare these regimens in terms of pain intensity and correlate pain with quality of life and toxicity in these patients.

OUTLINE: This is a randomized study. Patients are stratified by disease status, performance status, and participating institution. Patients are randomized to one of two treatment arms. Arm I: Patients receive cisplatin IV over 30-120 minutes on day 1 and fluorouracil IV over 96 hours on days 1-4. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive paclitaxel IV over 3 hours followed by cisplatin IV over 30-120 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Treatment continues until 2 courses past complete response (minimum of 6 courses). Patients with stable disease may discontinue treatment after 6 courses. Patients are followed every 3 months until disease progression.

PROJECTED ACCRUAL: A total of 212 patients will be accrued for this study over 2.25 years.

Connect with a study center

  • MBCCOP - University of South Alabama

    Mobile, Alabama 36688
    United States

    Site Not Available

  • CCOP - Greater Phoenix

    Phoenix, Arizona 85006-2726
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Phoenix (Hayden)

    Phoenix, Arizona 85012
    United States

    Site Not Available

  • Arizona Cancer Center

    Tucson, Arizona 85724
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Tucson

    Tucson, Arizona 85723
    United States

    Site Not Available

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Little Rock (McClellan)

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Beckman Research Institute, City of Hope

    Duarte, California 91010
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Long Beach

    Long Beach, California 90822
    United States

    Site Not Available

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California 90095-1781
    United States

    Site Not Available

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California 90033-0800
    United States

    Site Not Available

  • Veterans Affairs Outpatient Clinic - Martinez

    Martinez, California 94553
    United States

    Site Not Available

  • CCOP - Bay Area Tumor Institute

    Oakland, California 94609-3305
    United States

    Site Not Available

  • Chao Family Comprehensive Cancer Center

    Orange, California 92868
    United States

    Site Not Available

  • University of California Davis Medical Center

    Sacramento, California 95817
    United States

    Site Not Available

  • UCSF Cancer Center and Cancer Research Institute

    San Francisco, California 94115-0128
    United States

    Site Not Available

  • CCOP - Santa Rosa Memorial Hospital

    Santa Rosa, California 95403
    United States

    Site Not Available

  • David Grant Medical Center

    Travis Air Force Base, California 94535
    United States

    Site Not Available

  • University of Colorado Cancer Center

    Denver, Colorado 80262
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Denver

    Denver, Colorado 80220
    United States

    Site Not Available

  • CCOP - Atlanta Regional

    Atlanta, Georgia 30342-1701
    United States

    Site Not Available

  • Dwight David Eisenhower Army Medical Center

    Fort Gordon, Georgia 30905-5650
    United States

    Site Not Available

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)

    Hines, Illinois 60141
    United States

    Site Not Available

  • Loyola University Medical Center

    Maywood, Illinois 60153
    United States

    Site Not Available

  • CCOP - Central Illinois

    Springfield, Illinois 62526
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160-7357
    United States

    Site Not Available

  • CCOP - Wichita

    Wichita, Kansas 67214-3882
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Wichita

    Wichita, Kansas 67218
    United States

    Site Not Available

  • Albert B. Chandler Medical Center, University of Kentucky

    Lexington, Kentucky 40536-0084
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Lexington

    Lexington, Kentucky 40511-1093
    United States

    Site Not Available

  • MBCCOP - LSU Medical Center

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Tulane University School of Medicine

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Veterans Affairs Medical Center - New Orleans

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Louisiana State University Hospital - Shreveport

    Shreveport, Louisiana 71130-3932
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Shreveport

    Shreveport, Louisiana 71130
    United States

    Site Not Available

  • Boston Medical Center

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Boston (Jamaica Plain)

    Jamaica Plain, Massachusetts 02130
    United States

    Site Not Available

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan 48109-0752
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Ann Arbor

    Ann Arbor, Michigan 48105
    United States

    Site Not Available

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Detroit

    Detroit, Michigan 48201-1932
    United States

    Site Not Available

  • CCOP - Grand Rapids Clinical Oncology Program

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Providence Hospital - Southfield

    Southfield, Michigan 48075-9975
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Biloxi

    Biloxi, Mississippi 39531-2410
    United States

    Site Not Available

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216-4505
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Jackson

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Keesler Medical Center - Keesler AFB

    Keesler AFB, Mississippi 39534-2576
    United States

    Site Not Available

  • CCOP - Kansas City

    Kansas City, Missouri 64131
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Kansas City

    Kansas City, Missouri 64128
    United States

    Site Not Available

  • CCOP - St. Louis-Cape Girardeau

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • St. Louis University Health Sciences Center

    Saint Louis, Missouri 63110-0250
    United States

    Site Not Available

  • CCOP - Ozarks Regional

    Springfield, Missouri 65807
    United States

    Site Not Available

  • CCOP - Montana Cancer Consortium

    Billings, Montana 59101
    United States

    Site Not Available

  • University of New Mexico Cancer Research & Treatment Center

    Albuquerque, New Mexico 87131
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Albuquerque

    Albuquerque, New Mexico 87108-5138
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Brooklyn

    Brooklyn, New York 11209
    United States

    Site Not Available

  • Herbert Irving Comprehensive Cancer Center

    New York, New York 10032
    United States

    Site Not Available

  • Barrett Cancer Center, The University Hospital

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Cincinnati

    Cincinnati, Ohio 45220-2288
    United States

    Site Not Available

  • Cleveland Clinic Cancer Center

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • CCOP - Columbus

    Columbus, Ohio 43206
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio 45428
    United States

    Site Not Available

  • CCOP - Dayton

    Kettering, Ohio 45429
    United States

    Site Not Available

  • Oklahoma Medical Research Foundation

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Oklahoma City

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • CCOP - Columbia River Program

    Portland, Oregon 97213
    United States

    Site Not Available

  • Oregon Cancer Center at Oregon Health Sciences University

    Portland, Oregon 97201-3098
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Portland

    Portland, Oregon 97207
    United States

    Site Not Available

  • CCOP - Greenville

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Brooke Army Medical Center

    Fort Sam Houston, Texas 78234
    United States

    Site Not Available

  • University of Texas Medical Branch

    Galveston, Texas 77555-1329
    United States

    Site Not Available

  • Texas Tech University Health Science Center

    Lubbock, Texas 79423
    United States

    Site Not Available

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas 78284
    United States

    Site Not Available

  • Veterans Affairs Medical Center - San Antonio (Murphy)

    San Antonio, Texas 78284
    United States

    Site Not Available

  • CCOP - Scott and White Hospital

    Temple, Texas 76508
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Temple

    Temple, Texas 76504
    United States

    Site Not Available

  • Huntsman Cancer Institute

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Salt Lake City

    Salt Lake City, Utah 84148
    United States

    Site Not Available

  • CCOP - Southwestern Vermont Regional Cancer Center

    Bennington, Vermont 05201
    United States

    Site Not Available

  • CCOP - Virginia Mason Research Center

    Seattle, Washington 98101
    United States

    Site Not Available

  • Swedish Hospital Tumor Institute

    Seattle, Washington 98104
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Seattle

    Seattle, Washington 98108
    United States

    Site Not Available

  • CCOP - Northwest

    Tacoma, Washington 98405-0986
    United States

    Site Not Available

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