Paclitaxel, Cisplatin, and Filgrastim Combined With Radiation Therapy in Treating Patients With Locally Recurrent Head and Neck Cancer
- Conditions
- Head and Neck Cancer
- Interventions
- Biological: filgrastimProcedure: conventional surgeryRadiation: radiation therapy
- Registration Number
- NCT00005087
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Radiation therapy uses high-energy x-rays to damage tumor cells.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel, cisplatin, and filgrastim combined with radiation therapy in treating patients who have locally recurrent head and neck cancer and have received previous treatment with radiation therapy.
- Detailed Description
OBJECTIVES:
* Determine the median, one-year, and long-term (defined as two-year) disease-free survival and overall survival in patients with previously irradiated locally recurrent squamous cell cancer of the head and neck treated with paclitaxel, cisplatin, and filgrastim (G-CSF) combined with radiotherapy.
* Determine the rates of acute and late toxic effects of this regimen in these patients.
* Determine the pattern of disease progression in patients treated with this regimen.
OUTLINE: Patients undergo radiotherapy twice daily (4-6 hours apart) on days 1-5. Patients receive paclitaxel IV over 1 hour beginning immediately after completion of the first fraction of radiotherapy and completing less than 3 hours before starting the second fraction of radiotherapy on days 1-5. Patients receive cisplatin IV over 30 minutes beginning immediately after completion of paclitaxel infusion on days 1-5 and filgrastim (G-CSF) subcutaneously on days 6-13. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who initially respond to therapy but develop a recurrence with a resectable lesion (inside or outside the retreatment field) may undergo surgical resection.
Patients are followed at 4 weeks after completion of radiotherapy, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 34 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Radiation (BID) and chemotherapy conventional surgery Radiation (BID), cisplatin and paclitaxel given on days 1-5 (Monday-Friday) in weeks 1, 3, 5 and 7. G-CSF given on days 6-13. Radiation (BID) and chemotherapy filgrastim Radiation (BID), cisplatin and paclitaxel given on days 1-5 (Monday-Friday) in weeks 1, 3, 5 and 7. G-CSF given on days 6-13. Radiation (BID) and chemotherapy cisplatin Radiation (BID), cisplatin and paclitaxel given on days 1-5 (Monday-Friday) in weeks 1, 3, 5 and 7. G-CSF given on days 6-13. Radiation (BID) and chemotherapy paclitaxel Radiation (BID), cisplatin and paclitaxel given on days 1-5 (Monday-Friday) in weeks 1, 3, 5 and 7. G-CSF given on days 6-13. Radiation (BID) and chemotherapy radiation therapy Radiation (BID), cisplatin and paclitaxel given on days 1-5 (Monday-Friday) in weeks 1, 3, 5 and 7. G-CSF given on days 6-13.
- Primary Outcome Measures
Name Time Method Overall Survival From registration to 1 year
- Secondary Outcome Measures
Name Time Method Disease-free Survival From registration to 1 year Grade 4-5 toxicity From one year after the start of radiation therapy to last follow-up. Pattern of failure (local-regional, distant, new primary, death) From registration to last follow-up.
Trial Locations
- Locations (235)
Mount Diablo Medical Center
🇺🇸Concord, California, United States
Wilkes Barre General Hospital
🇺🇸Wilkes-Barre, Pennsylvania, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
Greater Baltimore Medical Center and Cancer Center
🇺🇸Baltimore, Maryland, United States
Veterans Affairs Medical Center - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Harbor Hospital Center
🇺🇸Baltimore, Maryland, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Toronto Sunnybrook Regional Cancer Centre
🇨🇦Toronto, Ontario, Canada
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Newfoundland Cancer Treatment and Research Foundation
🇨🇦St. Johns, Newfoundland and Labrador, Canada
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Mercy Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
St. John's Medical Center
🇺🇸Anderson, Indiana, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
🇺🇸Indianapolis, Indiana, United States
Ingalls Memorial Hospital
🇺🇸Harvey, Illinois, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Bloomington Hospital
🇺🇸Bloomington, Indiana, United States
MidMichigan Medical Center - Midland
🇺🇸Midland, Michigan, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Central Baptist Hospital
🇺🇸Lexington, Kentucky, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
Ball Memorial Hospital
🇺🇸Muncie, Indiana, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
John F. Kennedy Medical Center
🇺🇸Edison, New Jersey, United States
Mercy Hospital Cancer Center - Scranton
🇺🇸Scranton, Pennsylvania, United States
Akron City Hospital
🇺🇸Akron, Ohio, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
State University of New York Health Science Center at Brooklyn
🇺🇸Brooklyn, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸Syracuse, New York, United States
Veterans Affairs Medical Center - East Orange
🇺🇸East Orange, New Jersey, United States
Trinitas Hospital - Jersey Street Campus
🇺🇸Elizabeth, New Jersey, United States
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
St. Louis University Health Sciences Center
🇺🇸Saint Louis, Missouri, United States
Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Mallinckrodt Institute of Radiology
🇺🇸Saint Louis, Missouri, United States
Radiation Oncology Associates of Albuquerque
🇺🇸Albuquerque, New Mexico, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
St. John Health System
🇺🇸Tulsa, Oklahoma, United States
CCOP - Toledo Community Hospital
🇺🇸Toledo, Ohio, United States
St. Francis Medical Center
🇺🇸Trenton, New Jersey, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
CCOP - Oklahoma
🇺🇸Tulsa, Oklahoma, United States
Mercy Fitzgerald Hospital
🇺🇸Darby, Pennsylvania, United States
Vermont Cancer Center
🇺🇸Burlington, Vermont, United States
Bon Secours - St. Mary's Hospital
🇺🇸Richmond, Virginia, United States
Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
Akron General Medical Center
🇺🇸Akron, Ohio, United States
Joe Arrington Cancer Research and Treatment Center
🇺🇸Lubbock, Texas, United States
Vassar Brothers Medical Center
🇺🇸Poughkeepsie, New York, United States
Northeast Medical Center
🇺🇸Concord, North Carolina, United States
Delaware County Memorial Hospital
🇺🇸Drexel Hill, Pennsylvania, United States
South Jersey Regional Cancer Center
🇺🇸Millville, New Jersey, United States
Wilford Hall Medical Center
🇺🇸Lackland Air Force Base, Texas, United States
Trinity Cancer Care Center
🇺🇸Minot, North Dakota, United States
Albert Einstein Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Naval Medical Center, Portsmouth
🇺🇸Portsmouth, Virginia, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Bayshore Medical Center
🇺🇸Pasadena, Texas, United States
Dixie Regional Medical Center
🇺🇸Saint George, Utah, United States
Yakima Valley Memorial Hospital
🇺🇸Yakima, Washington, United States
Community Memorial Hospital
🇺🇸Menomonee Falls, Wisconsin, United States
St. Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
Nova Scotia Cancer Centre
🇨🇦Halifax, Nova Scotia, Canada
Waukesha Memorial Hospital
🇺🇸Waukesha, Wisconsin, United States
Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Saint John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada
Gundersen Lutheran Medical Foundation
🇺🇸La Crosse, Wisconsin, United States
Schiffler Cancer Center
🇺🇸Wheeling, West Virginia, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Southern Wisconsin Radiotherapy Center
🇺🇸Madison, Wisconsin, United States
Tom Baker Cancer Center - Calgary
🇨🇦Calgary, Alberta, Canada
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
Sylvester Cancer Center, University of Miami
🇺🇸Miami, Florida, United States
Clarian Health Partners Inc.
🇺🇸Indianapolis, Indiana, United States
Regional Cancer Center
🇺🇸Indianapolis, Indiana, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Peninsula Regional Medical Center
🇺🇸Salisbury, Maryland, United States
Radiation Medical Group, Inc.
🇺🇸San Diego, California, United States
Barrett Cancer Center
🇺🇸Cincinnati, Ohio, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
University of Utah Health Sciences Center
🇺🇸Salt Lake City, Utah, United States
Latter Day Saints Hospital
🇺🇸Salt Lake City, Utah, United States
Foundation for Cancer Research and Education
🇺🇸Phoenix, Arizona, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
St. Anthony Hospital
🇺🇸Oklahoma City, Oklahoma, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
CCOP - Columbia River Program
🇺🇸Portland, Oregon, United States
Columbia Hospital
🇺🇸Milwaukee, Wisconsin, United States
St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
🇺🇸Milwaukee, Wisconsin, United States
Cancer Care Ontario-London Regional Cancer Centre
🇨🇦London, Ontario, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Ottawa Regional Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Champlain Valley Physicians Hospital Medical Center
🇺🇸Plattsburgh, New York, United States
Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
Community Medical Center
🇺🇸Toms River, New Jersey, United States
Radiation Oncology Center - Sacramento
🇺🇸Sacramento, California, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Methodist Hospital Cancer Center - Omaha
🇺🇸Omaha, Nebraska, United States
Nebraska Health System
🇺🇸Omaha, Nebraska, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
Reading Hospital and Medical Center
🇺🇸Reading, Pennsylvania, United States
Comprehensive Cancer Institute of Huntsville
🇺🇸Huntsville, Alabama, United States
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
Huntsville Hospital System
🇺🇸Huntsville, Alabama, United States
DCH Cancer Treatment Center
🇺🇸Tuscaloosa, Alabama, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Veterans Affairs Medical Center - Long Beach
🇺🇸Long Beach, California, United States
Saint Agnes Cancer Center
🇺🇸Fresno, California, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Sutter Health West Cancer Research Group
🇺🇸Greenbrae, California, United States
Huntington Cancer Center
🇺🇸Pasadena, California, United States
California Cancer Center
🇺🇸Fresno, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
Robert and Beverly Lewis Family Cancer Care Center
🇺🇸Pomona, California, United States
Memorial Hospital Cancer Center
🇺🇸Colorado Springs, Colorado, United States
David Grant Medical Center
🇺🇸Travis Air Force Base, California, United States
CCOP - Santa Rosa Memorial Hospital
🇺🇸Santa Rosa, California, United States
O'Connor Hospital
🇺🇸San Jose, California, United States
Saint Mary's Hospital and Medical Center
🇺🇸Grand Junction, Colorado, United States
CCOP - Christiana Care Health Services
🇺🇸Wilmington, Delaware, United States
Health First Holmes Regional Medical Center
🇺🇸Melbourne, Florida, United States
University of Florida Health Science Center
🇺🇸Gainesville, Florida, United States
Florida Radiation Oncology Group
🇺🇸Jacksonville, Florida, United States
Veterans Affairs Medical Center - Miami
🇺🇸Miami, Florida, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Bay Medical Center
🇺🇸Panama City, Florida, United States
Gulf Coast Cancer Treatment Center
🇺🇸Panama City, Florida, United States
Sarasota Radiation and Medical Oncology Center
🇺🇸Sarasota, Florida, United States
Tallahassee Memorial Healthcare
🇺🇸Tallahassee, Florida, United States
MBCCOP - Hawaii
🇺🇸Honolulu, Hawaii, United States
Regional Radiation Oncology Center at Rome
🇺🇸Rome, Georgia, United States
Medical Center/John B. Amos Community Cancer Center
🇺🇸Columbus, Georgia, United States
Northwest Community Hospital
🇺🇸Arlington Heights, Illinois, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
Lutheran General Cancer Care Center
🇺🇸Park Ridge, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Wendt Regional Cancer Center of Finley Hospital
🇺🇸Dubuque, Iowa, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Merle M. Mahr Cancer Center
🇺🇸Madisonville, Kentucky, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
MBCCOP - LSU Medical Center
🇺🇸New Orleans, Louisiana, United States
Anne Arundel Oncology Center
🇺🇸Annapolis, Maryland, United States
CCOP - Ochsner
🇺🇸New Orleans, Louisiana, United States
Mary Bird Perkins Cancer Center
🇺🇸Baton Rouge, Louisiana, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
🇺🇸Jamaica Plain, Massachusetts, United States
Cape Cod Hospital
🇺🇸Hyannis, Massachusetts, United States
Marquette General Hospital
🇺🇸Marquette, Michigan, United States
McLaren Regional Cancer Center
🇺🇸Flint, Michigan, United States
William Beaumont Hospital - Troy
🇺🇸Troy, Michigan, United States
CCOP - Beaumont
🇺🇸Royal Oak, Michigan, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
Elliot Regional Cancer Center
🇺🇸Manchester, New Hampshire, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
🇺🇸Mount Holly, New Jersey, United States
Atlantic City Medical Center
🇺🇸Pomona, New Jersey, United States
Associated Radiologists, P.A.
🇺🇸Warren, New Jersey, United States
Cancer Center of Albany Medical Center
🇺🇸Albany, New York, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
New York Methodist Hospital
🇺🇸Brooklyn, New York, United States
Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
Finger Lakes Radiation Oncology Center
🇺🇸Clifton Springs, New York, United States
Riverhill Radiation Oncology
🇺🇸Yonkers, New York, United States
James P. Wilmot Cancer Center
🇺🇸Rochester, New York, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
East Carolina University School of Medicine
🇺🇸Greenville, North Carolina, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
St. Luke's Hospital Cancer Center
🇺🇸Bethlehem, Pennsylvania, United States
Pocono Cancer Center
🇺🇸East Stroudsburg, Pennsylvania, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Roger Williams Medical Center/BUSM
🇺🇸Providence, Rhode Island, United States
York Cancer Center
🇺🇸York, Pennsylvania, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
Jackson-Madison County General Hospital
🇺🇸Jackson, Tennessee, United States
University of Tennessee Cancer Institute
🇺🇸Memphis, Tennessee, United States
Harrington Cancer Center
🇺🇸Amarillo, Texas, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Cancer Center at the University of Virginia
🇺🇸Charlottesville, Virginia, United States
RMH Regional Cancer Center
🇺🇸Harrisonburg, Virginia, United States
Deaconess Medical Center
🇺🇸Spokane, Washington, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
🇺🇸Green Bay, Wisconsin, United States
All Saints Cancer Center
🇺🇸Racine, Wisconsin, United States
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
🇨🇦Sudbury, Ontario, Canada
Kingston Regional Cancer Centre
🇨🇦Kingston, Ontario, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
🇨🇦Thunder Bay, Ontario, Canada
CHUS-Hopital Fleurimont
🇨🇦Fleurimont, Quebec, Canada
McGill University
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
🇨🇦Quebec City, Quebec, Canada
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
Hospital of St. Raphael
🇺🇸New Haven, Connecticut, United States
MD Anderson Cancer Center Orlando
🇺🇸Orlando, Florida, United States
James Graham Brown Cancer Center
🇺🇸Louisville, Kentucky, United States
Louisville Radiation Oncology
🇺🇸Louisville, Kentucky, United States
Alabama Oncology, LLC
🇺🇸Montgomery, Alabama, United States
Monmouth Medical Center
🇺🇸Long Branch, New Jersey, United States