Radiation Therapy With or Without Epoetin Alfa in Treating Anemic Patients With Head and Neck Cancer
Anemia, Head and Neck Cancer
About this trial
This is an interventional treatment trial for Anemia focused on measuring 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, stage IV 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, stage IV 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, stage IV 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, stage IV squamous cell carcinoma of the larynx, anemia
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed invasive squamous cell carcinoma of the head and neck, including carcinoma arising from the oral cavity, oropharynx, larynx, and hypopharynx Stage I-IV disease No distant metastases No carcinoma of the nasopharynx, nasal cavity/paranasal sinuses, or salivary glands No carcinoma in situ without an identifiable invasive component Plan for radiotherapy in continuous course Prior surgical exploration with gross residual disease remaining allowed Prior neck dissection with or without biopsy of primary tumor, but no radical surgery for primary tumor, allowed Anemia, defined as hemoglobin no greater than 13.5 g/dL for males and no greater than 12.5 g/dL for females (transfusion prior to study allowed) No severe anemia (i.e., hemoglobin less than 9.0 g/dL) No anemia confirmed to be due to causes other than chronic disease (e.g., iron deficiency anemia) Not entered on other RTOG head and neck protocols PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Stage III/IV patients receiving concurrent cisplatin: Absolute neutrophil count at least 2,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Not specified Renal: Stage III/IV patients receiving concurrent cisplatin: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 50 mL/min Cardiovascular: No malignant or poorly controlled hypertension (e.g., symptomatic hypertension or diastolic blood pressure of 100 mm Hg or greater despite antihypertensive medication) No unstable angina or other poorly controlled cardiac disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception If stage III or IV disease is present, willing to come for twice daily radiotherapy for the last 2.5 weeks of therapy No active infection requiring IV antibiotics No unexplained fever No AIDS or other history of congenital or acquired immunodeficiency No other malignancies within the past 3 years except carcinoma in situ or nonmelanomatous skin cancer No known hypersensitivity to mammalian cell-derived products or to human albumin No acute/subacute illness that would make the need for transfusion likely PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since other prior cytokine therapy (e.g., filgrastim [G-CSF], interleukins, or interferons) No prior epoetin alfa No other concurrent cytokine therapy Chemotherapy: No prior chemotherapy Concurrent cisplatin, paclitaxel/cisplatin, or paclitaxel/carboplatin for patients with stage III/IV disease is allowed Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy to the head and neck Surgery: See Disease Characteristics Other: No concurrent amifostine No concurrent transfusion
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
- Providence Saint Joseph Medical Center - Burbank
- Mount Diablo Medical Center
- City of Hope Comprehensive Cancer Center
- California Cancer Center
- Saint Agnes Cancer Center
- Sutter Health Western Division Cancer Research Group
- Loma Linda University Medical Center
- Veterans Affairs Medical Center - Long Beach
- USC/Norris Comprehensive Cancer Center and Hospital
- Jonsson Comprehensive Cancer Center, UCLA
- CCOP - Bay Area Tumor Institute
- Huntington Cancer Center
- Robert and Beverly Lewis Family Cancer Care Center
- Radiation Oncology Center - Sacramento
- Radiation Medical Group, Incorporated
- Naval Medical Center - San Diego
- UCSF Comprehensive Cancer Center
- O'Connor Hospital
- CCOP - Santa Rosa Memorial Hospital
- Torrance Memorial Medical Center
- David Grant Medical Center
- Memorial Hospital Cancer Center
- University of Colorado Cancer Center
- CCOP - Colorado Cancer Research Program, Incorporated
- Saint Mary's Hospital and Medical Center
- Yale Comprehensive Cancer Center
- CCOP - Christiana Care Health Services
- Sibley Memorial Hospital
- 21st Century Oncology - Fort Myers
- University of Florida Health Science Center
- Florida Radiation Oncology Group
- 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
- CCOP - Scott and White Hospital
- Methodist Medical Center of Illinois
- St. John's Medical Center
- Bloomington Hospital
- Veterans Affairs Medical Center - Indianapolis (Roudebush)
- Clarian Health Partners Inc.
- Community Regional Cancer Care
- Ball Memorial Hospital
- CCOP - Northern Indiana CR Consortium
- Wendt Regional Cancer Center of Finley Hospital
- St. Elizabeth Medical Center
- Central Baptist Hospital
- Cancer Center at Lexington Clinic
- 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 Health Sciences 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
- St. Agnes Cancer Center
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Peninsula Regional Medical Center
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- Boston Medical Center
- Cape Cod Hospital
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
- NSMC Cancer Center
- CCOP - Michigan Cancer Research Consortium
- 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
- Fairview University Medical Center
- 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
- Comprehensive Cancer Centers of Nevada
- 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
- Medical Center of Princeton
- 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
- Beth Israel Medical Center
- Herbert Irving Comprehensive Cancer Center
- Champlain Valley Physicians Hospital 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
- Barrett Cancer Center
- Christ Hospital
- Ireland Cancer Center
- University Hospitals of Cleveland
- Cleveland Clinic Taussig Cancer Center
- CCOP - Columbus
- Arthur G. James Cancer Hospital - Ohio State University
- CCOP - Dayton
- Parma Community General Hospital
- CCOP - Toledo Community Hospital
- St. Anthony Hospital
- University of Oklahoma Health Sciences Center
- St. John Health System
- CCOP - Oklahoma
- CCOP - Columbia River Oncology Program
- Abington Memorial Hospital
- 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
- Abramson Cancer Center of the University of Pennsylvania
- Veterans Affairs Medical Center - Philadelphia
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
- Fox Chase Cancer Center
- Albert Einstein Cancer Center
- Allegheny General Hospital
- Mercy Hospital of Pittsburgh
- Western Pennsylvania Hospital
- University of Pittsburgh Cancer Institute
- Reading Hospital and Medical Center
- Mercy Hospital Cancer Center - Scranton
- Wilkes Barre General Hospital
- CCOP - MainLine Health
- 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
- Arlington 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
- University of Texas Health Science Center at San Antonio
- Utah Valley Regional Medical Center - Provo
- Dixie Regional Medical Center
- University of Utah Health Sciences Center
- Latter Day Saints Hospital
- Green Mountain Oncology Group
- 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
- University of Washington 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 Cancer Center
- Veterans Affairs Medical Center - Milwaukee (Zablocki)
- All Saints Cancer Center
- Waukesha Memorial Hospital Regional Cancer Center
- Tom Baker Cancer Center - Calgary
- Cross Cancer Institute
- Doctor Leon Richard Oncology Centre
- 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
- Jin Soo Lee Practice Inc.