Paclitaxel, Cisplatin, and Filgrastim Combined With Radiation Therapy in Treating Patients With Locally Recurrent Head and Neck Cancer
Head and Neck Cancer
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring recurrent metastatic squamous neck cancer with occult primary, metastatic squamous neck cancer with occult primary squamous cell carcinoma, stage I squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, stage I squamous cell carcinoma of the oropharynx, stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, stage I squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx, stage I squamous cell carcinoma of the larynx, stage II squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, stage I squamous cell carcinoma of the paranasal sinus and nasal cavity, stage II squamous cell carcinoma of the paranasal sinus and nasal cavity, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven locally recurrent primary squamous cell cancer (SCC) of the head and neck or second primary SCC of the head and neck More than 1 prior recurrence allowed if the first recurrence occurred at least 6 months after completion of prior radiotherapy Disease must be confined to the head and neck (above the clavicles) No primary SCC of the nasopharynx or salivary gland Prior irradiation of 45-75 Gy to the majority (75% or greater) of tumor volume Entire tumor volume must be included in a treatment field that limits the total spinal cord dose (prior and anticipated) to 50 Gy Prior radiotherapy records, including simulation and portal films, available in order to assure that cord tolerance is not exceeded Measurable disease Ineligible for complete surgical resection No distant metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0 or 1 Life expectancy: No other concurrent illness that would limit survival Hematopoietic: Granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 mg/dL Serum glutamate oxaloacetate transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) no greater than 2 times normal* Alkaline phosphatase no greater than 2 times normal* * Greater than 2 times normal allowed if no metastases by liver ultrasound or CT scan Renal: Creatinine no greater than 1.5 mg/dL Other: No other invasive malignancy within the past 2 years except in situ malignancies (e.g., carcinoma in situ of the cervix, carcinoma in situ of the breast, or nonmelanoma skin cancer) No other concurrent illness that would impair tolerance to therapy No grade 2 or worse pre-existing peripheral sensory neuropathy No hypersensitivity to E. coli derived products Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior chemotherapy allowed as a component of the primary treatment No prior chemotherapy for recurrent disease At least 6 months since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 6 months since prior radiotherapy Surgery: See Disease Characteristics
Sites / Locations
- University of Alabama at Birmingham Comprehensive Cancer Center
- Comprehensive Cancer Institute of Huntsville
- Huntsville Hospital System
- MBCCOP - Gulf Coast
- Alabama Oncology, LLC
- DCH Cancer Treatment Center
- Foundation for Cancer Research and Education
- Mount Diablo Medical Center
- City of Hope Comprehensive Cancer Center
- Saint Agnes Cancer Center
- California Cancer Center
- Sutter Health West Cancer Research Group
- Loma Linda University Medical Center
- Veterans Affairs Medical Center - Long Beach
- Jonsson Comprehensive Cancer Center, UCLA
- USC/Norris Comprehensive Cancer Center and Hospital
- CCOP - Bay Area Tumor Institute
- Huntington Cancer Center
- Robert and Beverly Lewis Family Cancer Care Center
- Radiation Oncology Center - Sacramento
- Radiation Medical Group, Inc.
- UCSF Comprehensive Cancer Center
- O'Connor Hospital
- CCOP - Santa Rosa Memorial Hospital
- David Grant Medical Center
- Memorial Hospital Cancer Center
- University of Colorado Cancer Center
- Saint Mary's Hospital and Medical Center
- Hospital of St. Raphael
- CCOP - Christiana Care Health Services
- University of Florida Health Science Center
- Florida Radiation Oncology Group
- Health First Holmes Regional Medical Center
- CCOP - Mount Sinai Medical Center
- Veterans Affairs Medical Center - Miami
- Sylvester Cancer Center, University of Miami
- Baptist Hospital of Miami
- MD Anderson Cancer Center Orlando
- Bay Medical Center
- Gulf Coast Cancer Treatment Center
- Sarasota Radiation and Medical Oncology Center
- Tallahassee Memorial Healthcare
- H. Lee Moffitt Cancer Center and Research Institute
- Emory University Hospital - Atlanta
- CCOP - Atlanta Regional
- Medical Center/John B. Amos Community Cancer Center
- Regional Radiation Oncology Center at Rome
- MBCCOP - Hawaii
- Northwest Community Hospital
- Northwestern Memorial Hospital
- CCOP - Central Illinois
- Ingalls Memorial Hospital
- Loyola University Medical Center
- Lutheran General Cancer Care Center
- Methodist Medical Center of Illinois
- St. John's Medical Center
- Bloomington Hospital
- Veterans Affairs Medical Center - Indianapolis (Roudebush)
- Clarian Health Partners Inc.
- Regional Cancer Center
- Ball Memorial Hospital
- CCOP - Northern Indiana CR Consortium
- Wendt Regional Cancer Center of Finley Hospital
- Central Baptist Hospital
- Albert B. Chandler Medical Center, University of Kentucky
- James Graham Brown Cancer Center
- Louisville Radiation Oncology
- Merle M. Mahr Cancer Center
- Mary Bird Perkins Cancer Center
- Tulane University School of Medicine
- MBCCOP - LSU Medical Center
- CCOP - Ochsner
- Maine Medical Center
- Anne Arundel Oncology Center
- Marlene and Stewart Greenebaum Cancer Center, University of Maryland
- Greater Baltimore Medical Center and Cancer Center
- Harbor Hospital Center
- Sinai Hospital of Baltimore
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Peninsula Regional Medical Center
- Dana-Farber Cancer Institute
- Cape Cod Hospital
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
- CCOP - Ann Arbor Regional
- University of Michigan Comprehensive Cancer Center
- Barbara Ann Karmanos Cancer Institute
- Henry Ford Hospital
- Hurley Medical Center
- McLaren Regional Cancer Center
- CCOP - Kalamazoo
- Marquette General Hospital
- MidMichigan Medical Center - Midland
- CCOP - Beaumont
- William Beaumont Hospital
- William Beaumont Hospital - Troy
- Mayo Clinic Cancer Center
- CCOP - Metro-Minnesota
- Ellis Fischel Cancer Center - Columbia
- CCOP - Kansas City
- Mallinckrodt Institute of Radiology
- St. Louis University Health Sciences Center
- Cancer Research for the Ozarks
- CCOP - Cancer Research for the Ozarks
- CCOP - Montana Cancer Consortium
- CCOP - Missouri Valley Cancer Consortium
- Methodist Hospital Cancer Center - Omaha
- Nebraska Health System
- CCOP - Southern Nevada Cancer Research Foundation
- Norris Cotton Cancer Center
- Elliot Regional Cancer Center
- Veterans Affairs Medical Center - East Orange
- John F. Kennedy Medical Center
- Trinitas Hospital - Jersey Street Campus
- Monmouth Medical Center
- South Jersey Regional Cancer Center
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
- Cancer Institute of New Jersey
- Newark Beth Israel Medical Center
- Atlantic City Medical Center
- Valley Hospital
- Community Medical Center
- St. Francis Medical Center
- Associated Radiologists, P.A.
- Radiation Oncology Associates of Albuquerque
- Cancer Center of Albany Medical Center
- State University of New York Health Science Center at Brooklyn
- New York Methodist Hospital
- Roswell Park Cancer Institute
- Finger Lakes Radiation Oncology Center
- CCOP - North Shore University Hospital
- Herbert Irving Comprehensive Cancer Center
- Champlain Valley Physicians Hospital Medical Center
- Vassar Brothers Medical Center
- James P. Wilmot Cancer Center
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
- Riverhill Radiation Oncology
- Lineberger Comprehensive Cancer Center, UNC
- Northeast Medical Center
- East Carolina University School of Medicine
- CCOP - Southeast Cancer Control Consortium
- Comprehensive Cancer Center at Wake Forest University
- Trinity Cancer Care Center
- Akron General Medical Center
- Akron City Hospital
- Christ Hospital
- Barrett Cancer Center
- Ireland Cancer Center
- University Hospitals of Cleveland
- Cleveland Clinic Taussig Cancer Center
- CCOP - Columbus
- Arthur G. James Cancer Hospital - Ohio State University
- CCOP - Dayton
- CCOP - Toledo Community Hospital
- St. Anthony Hospital
- University of Oklahoma Health Sciences Center
- St. John Health System
- CCOP - Oklahoma
- CCOP - Columbia River Program
- Lehigh Valley Hospital
- St. Luke's Hospital Cancer Center
- Geisinger Medical Center
- Mercy Fitzgerald Hospital
- Delaware County Memorial Hospital
- Pocono Cancer Center
- Milton S. Hershey Medical Center
- University of Pennsylvania Cancer Center
- Veterans Affairs Medical Center - Philadelphia
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
- Fox Chase Cancer Center
- Albert Einstein Cancer Center
- University of Pittsburgh Cancer Institute
- Mercy Hospital of Pittsburgh
- Western Pennsylvania Hospital
- Reading Hospital and Medical Center
- Mercy Hospital Cancer Center - Scranton
- Wilkes Barre General Hospital
- York Cancer Center
- Roger Williams Medical Center/BUSM
- CCOP - Greenville
- CCOP - Upstate Carolina
- Rapid City Regional Hospital
- Jackson-Madison County General Hospital
- University of Tennessee Cancer Institute
- Vanderbilt-Ingram Cancer Center
- Harrington Cancer Center
- University of Texas Medical Branch
- University of Texas - MD Anderson Cancer Center
- Wilford Hall Medical Center
- Joe Arrington Cancer Research and Treatment Center
- Bayshore Medical Center
- Dixie Regional Medical Center
- University of Utah Health Sciences Center
- Latter Day Saints Hospital
- Vermont Cancer Center
- Cancer Center at the University of Virginia
- RMH Regional Cancer Center
- Naval Medical Center, Portsmouth
- Bon Secours - St. Mary's Hospital
- Massey Cancer Center
- Virginia Mason Medical Center
- Deaconess Medical Center
- Yakima Valley Memorial Hospital
- Schiffler Cancer Center
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
- St. Vincent Hospital
- Gundersen Lutheran Medical Foundation
- Southern Wisconsin Radiotherapy Center
- University of Wisconsin Comprehensive Cancer Center
- Marshfield Clinic
- Community Memorial Hospital
- Columbia Hospital
- St. Luke's Medical Center
- Medical College of Wisconsin
- Veterans Affairs Medical Center - Milwaukee (Zablocki)
- All Saints Cancer Center
- Waukesha Memorial Hospital
- Tom Baker Cancer Center - Calgary
- Cross Cancer Institute
- Saint John Regional Hospital
- Newfoundland Cancer Treatment and Research Foundation
- Nova Scotia Cancer Centre
- Cancer Care Ontario-Hamilton Regional Cancer Centre
- Kingston Regional Cancer Centre
- Cancer Care Ontario-London Regional Cancer Centre
- Ottawa Regional Cancer Centre
- Northeastern Ontario Regional Cancer Centre, Sudbury
- Northwestern Ontario Regional Cancer Centre, Thunder Bay
- Toronto Sunnybrook Regional Cancer Centre
- Princess Margaret Hospital
- CHUS-Hopital Fleurimont
- Centre Hospitalier de l'Universite de Montreal
- McGill University
- Centre Hospitalier Universitaire de Quebec
- Allan Blair Cancer Centre
- Saskatoon Cancer Centre
Arms of the Study
Arm 1
Experimental
Radiation (BID) and chemotherapy
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.