Head and Neck Cancer Clinical Trial
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
Verified date | July 2011 |
Source | Southwest Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | November 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Hospital for Sick Children | Toronto | Ontario |
United States | MBCCOP - University of New Mexico HSC | Albuquerque | New Mexico |
United States | Veterans Affairs Medical Center - Albuquerque | Albuquerque | New Mexico |
United States | Harrington Cancer Center | Amarillo | Texas |
United States | Veterans Affairs Medical Center - Amarillo | Amarillo | Texas |
United States | CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan |
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | Veterans Affairs Medical Center - Ann Arbor | Ann Arbor | Michigan |
United States | CCOP - Atlanta Regional | Atlanta | Georgia |
United States | University of Colorado Cancer Center at University of Colorado Health Sciences Center | Aurora | Colorado |
United States | CCOP - Montana Cancer Consortium | Billings | Montana |
United States | University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham | Alabama |
United States | Cancer Research Center at Boston Medical Center | Boston | Massachusetts |
United States | Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina |
United States | Veterans Affairs Medical Center - Charleston | Charleston | South Carolina |
United States | MBCCOP - University of Illinois at Chicago | Chicago | Illinois |
United States | Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago | Illinois |
United States | Charles M. Barrett Cancer Center at University Hospital | Cincinnati | Ohio |
United States | Veterans Affairs Medical Center - Cincinnati | Cincinnati | Ohio |
United States | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio |
United States | CCOP - Columbus | Columbus | Ohio |
United States | CCOP - Dayton | Dayton | Ohio |
United States | Veterans Affairs Medical Center - Dayton | Dayton | Ohio |
United States | CCOP - Central Illinois | Decatur | Illinois |
United States | Veterans Affairs Medical Center - Denver | Denver | Colorado |
United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
United States | Josephine Ford Cancer Center at Henry Ford Hospital | Detroit | Michigan |
United States | Veterans Affairs Medical Center - Detroit | Detroit | Michigan |
United States | City of Hope Comprehensive Cancer Center | Duarte | California |
United States | Veterans Affairs Medical Center - East Orange | East Orange | New Jersey |
United States | Brooke Army Medical Center | Fort Sam Houston | Texas |
United States | California Cancer Center | Fresno | California |
United States | University of Texas Medical Branch | Galveston | Texas |
United States | CCOP - Grand Rapids | Grand Rapids | Michigan |
United States | CCOP - Greenville | Greenville | South Carolina |
United States | Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | Hines | Illinois |
United States | MBCCOP - Hawaii | Honolulu | Hawaii |
United States | University of Texas - MD Anderson Cancer Center | Houston | Texas |
United States | Veterans Affairs Medical Center - Houston | Houston | Texas |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | Veterans Affairs Medical Center - Jackson | Jackson | Mississippi |
United States | CCOP - Kansas City | Kansas City | Missouri |
United States | Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City | Kansas |
United States | Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington | Kentucky |
United States | Veterans Affairs Medical Center - Lexington | Lexington | Kentucky |
United States | Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas |
United States | Veterans Affairs Medical Center - Little Rock (McClellan) | Little Rock | Arkansas |
United States | USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California |
United States | Veterans Affairs Outpatient Clinic - Martinez | Martinez | California |
United States | Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois |
United States | University of Tennessee Cancer Institute | Memphis | Tennessee |
United States | MBCCOP - Gulf Coast | Mobile | Alabama |
United States | MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana |
United States | Tulane Cancer Center at Tulane University Hospital and Clinic | New Orleans | Louisiana |
United States | Veterans Affairs Medical Center - New Orleans | New Orleans | Louisiana |
United States | Herbert Irving Comprehensive Cancer Center at Columbia University | New York | New York |
United States | NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York | New York |
United States | CCOP - Bay Area Tumor Institute | Oakland | California |
United States | Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center | Orange | California |
United States | CCOP - Western Regional, Arizona | Phoenix | Arizona |
United States | Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) | Phoenix | Arizona |
United States | Cancer Institute at Oregon Health and Science University | Portland | Oregon |
United States | CCOP - Columbia River Oncology Program | Portland | Oregon |
United States | Veterans Affairs Medical Center - Portland | Portland | Oregon |
United States | James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York |
United States | CCOP - Beaumont | Royal Oak | Michigan |
United States | University of California Davis Cancer Center | Sacramento | California |
United States | CCOP - St. Louis-Cape Girardeau | Saint Louis | Missouri |
United States | St. Louis University Hospital Cancer Center | Saint Louis | Missouri |
United States | Veterans Affairs Medical Center - Salisbury | Salisbury | North Carolina |
United States | Huntsman Cancer Institute | Salt Lake City | Utah |
United States | Veterans Affairs Medical Center - Salt Lake City | Salt Lake City | Utah |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio | Texas |
United States | CCOP - Santa Rosa Memorial Hospital | Santa Rosa | California |
United States | CCOP - Virginia Mason Research Center | Seattle | Washington |
United States | Puget Sound Oncology Consortium | Seattle | Washington |
United States | Veterans Affairs Medical Center - Seattle | Seattle | Washington |
United States | Louisiana State University Health Sciences Center - Shreveport | Shreveport | Louisiana |
United States | Veterans Affairs Medical Center - Shreveport | Shreveport | Louisiana |
United States | Providence Cancer Institute at Providence Hospital | Southfield | Michigan |
United States | CCOP - Upstate Carolina | Spartanburg | South Carolina |
United States | CCOP - Cancer Research for the Ozarks | Springfield | Missouri |
United States | CCOP - Northwest | Tacoma | Washington |
United States | Madigan Army Medical Center | Tacoma | Washington |
United States | Veterans Affairs Medical Center - Tampa (Haley) | Tampa | Florida |
United States | CCOP - Scott and White Hospital | Temple | Texas |
United States | Veterans Affairs Medical Center - Temple | Temple | Texas |
United States | David Grant Medical Center | Travis Air Force Base | California |
United States | Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson | Arizona |
United States | Veterans Affairs Medical Center - Tucson | Tucson | Arizona |
United States | MBCCOP - Howard University Cancer Center | Washington | District of Columbia |
United States | CCOP - Wichita | Wichita | Kansas |
United States | Veterans Affairs Medical Center - Wichita | Wichita | Kansas |
United States | CCOP - Southeast Cancer Control Consortium | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Southwest Oncology Group | National Cancer Institute (NCI) |
United States, Canada,
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
Adelstein DJ, Moon J, Hanna E, Giri PG, Mills GM, Wolf GT, Urba SG. Docetaxel, cisplatin, and fluorouracil induction chemotherapy followed by accelerated fractionation/concomitant boost radiation and concurrent cisplatin in patients with advanced squamous — View Citation
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