Phase
Condition
Head And Neck Cancer
Nasopharyngeal Cancer
Human Papilloma Virus (Hpv)
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
DISEASE CHARACTERISTICS:
Histologically* or cytologically* confirmed squamous cell carcinoma (SCC) of the oral cavity, oropharynx, hypopharynx, or larynx, including any of the following histologic variants:
Spindle cell carcinoma
Poorly differentiated keratin-positive carcinoma
Lymphoepithelioma NOTE: *Biopsy or primary tumor and/or fine needle aspiration of the metastatic lymph node required
Original or second primary tumor
Recurrent neck metastases with unknown primary allowed
Locally recurrent disease
Measurable disease
Unresectable disease
Attempted surgical resection allowed provided surgery was performed ≥ 3 months ago, wound is completely healed, and there is no sign of carotid exposure
Must have had prior radiotherapy for SCC of the head and neck with > 75% of the present tumor volume in areas irradiated at doses ≥ 45 Gy but ≤ 75 Gy
Able to successfully re-irradiate the area of the gross tumor volume without exceeding lifetime spinal cord dose of 54 Gy as determined by physical examination and CT scan and/or MRI performed within the past 8 weeks
First recurrence occurred > 6 months after completion of radiotherapy
More than 1 recurrence allowed provided the above criteria for first recurrence has been met
No primary tumor of the nasopharynx or salivary gland
No distant metastases by history or physical examination, chest CT scan, and CT scan or MRI of the tumor site
Patients with equivocal pulmonary nodules are eligible provided the nodules are < 1 cm, can be safely biopsied, or are negative by positron emission tomography imaging
No circumferential tumor involvement of the carotid sheath by imaging unless prophylactic carotid stent is placed
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
Absolute neutrophil count ≥ 1,800/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)
Hepatic
AST or ALT < 2 times upper limit of normal (ULN)
Bilirubin < 1.5 mg/dL
No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
Renal
Creatinine clearance > 50 mL/min
Calcium < 11.5 mg/dL
Cardiovascular
No New York Heart Association class III or IV heart disease
No other symptomatic or uncontrolled cardiac disease
Pulmonary
No chronic obstructive pulmonary disease exacerbation
No other respiratory illness requiring hospitalization within the past 6 months or that would preclude study therapy
Immunologic
No AIDS
No prior allergic reaction to E. coli-derived products
No acute bacterial or fungal infection requiring IV antibiotics
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 30 days after completion of study treatment
No other invasive malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the breast, oral cavity, or cervix
No pre-existing peripheral sensory neuropathy > grade 2
No other severe active co-morbidity
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
At least 6 months since prior chemotherapy
No prior systemic chemotherapy for recurrent SCC of the head and neck
Prior neoadjuvant, adjuvant, and/or concurrent chemotherapy and radiotherapy for initial SCC of the head and neck allowed
Endocrine therapy
- Not specified
Radiotherapy
See Disease Characteristics
See Chemotherapy
At least 6 months since prior radiotherapy
Surgery
- See Disease Characteristics
Other
Prior cyclooxygenase-2 inhibitor or retinoids for chemoprevention allowed
At least 6 months since prior epidermal growth factor receptor (EGFR) inhibitors or other targeted agents
No prior EGFR inhibitors or other targeted agents for recurrent SCC of the head and neck
No concurrent cimetidine or allopurinol (for patients on arm II, regimen 1)
Study Design
Study Description
Connect with a study center
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama 35294
United StatesSite Not Available
Mobile Infirmary Medical Center
Mobile, Alabama 36652-2144
United StatesSite Not Available
St. Joseph's Mercy Cancer Center
Hot Springs, Arkansas 71913
United StatesSite Not Available
Auburn Radiation Oncology
Auburn, California 95603
United StatesSite Not Available
Radiation Oncology Centers - Cameron Park
Cameron Park, California 95682
United StatesSite Not Available
Mercy Cancer Center at Mercy San Juan Medical Center
Carmichael, California 95608
United StatesSite Not Available
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
Pomona, California 91767
United StatesSite Not Available
Radiation Oncology Center - Roseville
Roseville, California 95661
United StatesSite Not Available
Mercy General Hospital
Sacramento, California 95819
United StatesSite Not Available
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California 95815
United StatesSite Not Available
University of California Davis Cancer Center
Sacramento, California 95817
United StatesSite Not Available
Solano Radiation Oncology Center
Vacaville, California 95687
United StatesSite Not Available
Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center
Boca Raton, Florida 33486
United StatesSite Not Available
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida 33308
United StatesSite Not Available
University of Florida Shands Cancer Center
Gainesville, Florida 32610-0232
United StatesSite Not Available
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida 33458
United StatesSite Not Available
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida 33136
United StatesSite Not Available
CCOP - Mount Sinai Medical Center
Miami Beach, Florida 33140
United StatesSite Not Available
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida 33612-9497
United StatesSite Not Available
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia 30912
United StatesSite Not Available
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
Savannah, Georgia 31405
United StatesSite Not Available
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois 62002
United StatesSite Not Available
Rush-Copley Cancer Care Center
Aurora, Illinois 60507
United StatesSite Not Available
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois 60435
United StatesSite Not Available
Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
Olympia Fields, Illinois 60461
United StatesSite Not Available
Cancer Institute at St. John's Hospital
Springfield, Illinois 62702
United StatesSite Not Available
CCOP - Carle Cancer Center
Urbana, Illinois 61801
United StatesSite Not Available
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois 61801
United StatesSite Not Available
St. John's Cancer Center at St. John's Medical Center
Anderson, Indiana 46016
United StatesSite Not Available
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana 46107
United StatesSite Not Available
Elkhart General Hospital
Elkhart, Indiana 46515
United StatesSite Not Available
Indiana University Cancer Center
Indianapolis, Indiana 46202-5289
United StatesSite Not Available
Howard Community Hospital at Howard Regional Health System
Kokomo, Indiana 46904
United StatesSite Not Available
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana 46350
United StatesSite Not Available
Saint Anthony Memorial Health Centers
Michigan City, Indiana 46360
United StatesSite Not Available
Reid Hospital & Health Care Services, Incorporated
Richmond, Indiana 47374
United StatesSite Not Available
CCOP - Northern Indiana CR Consortium
South Bend, Indiana 46601
United StatesSite Not Available
Memorial Hospital of South Bend
South Bend, Indiana 46601
United StatesSite Not Available
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport, Louisiana 71130-3932
United StatesSite Not Available
MaineGeneral Medical Center - Waterville Campus
Waterville, Maine 04901
United StatesSite Not Available
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland 21231-2410
United StatesSite Not Available
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan 49221
United StatesSite Not Available
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan 48109-0942
United StatesSite Not Available
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan 48201-1379
United StatesSite Not Available
Breslin Cancer Center at Ingham Regional Medical Center
Lansing, Michigan 48910
United StatesSite Not Available
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
St. Joseph, Michigan 49085
United StatesSite Not Available
Saint Francis Medical Center
Cape Girardeau, Missouri 63701
United StatesSite Not Available
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
Gape Girardeau, Missouri 63701
United StatesSite Not Available
David C. Pratt Cancer Center at St. John's Mercy
Saint Louis, Missouri 63141
United StatesSite Not Available
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri 63110
United StatesSite Not Available
CCOP - St. Louis-Cape Girardeau
St. Louis, Missouri 63141
United StatesSite Not Available
CCOP - Montana Cancer Consortium
Billings, Montana 59101
United StatesSite Not Available
Deaconess Billings Clinic - Downtown
Billings, Montana 59107-7000
United StatesSite Not Available
Northern Rockies Radiation Oncology Center
Billings, Montana 59101
United StatesSite Not Available
Methodist Cancer Center at Methodist Hospital - Omaha
Omaha, Nebraska 68114
United StatesSite Not Available
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada 89106
United StatesSite Not Available
Kingsbury Center for Cancer Care at Cheshire Medical Center
Keene, New Hampshire 03431
United StatesSite Not Available
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756-0002
United StatesSite Not Available
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey 08053
United StatesSite Not Available
J. Phillip Citta Regional Cancer Center at Community Medical Center
Toms River, New Jersey 08755
United StatesSite Not Available
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
Vineland, New Jersey 08360
United StatesSite Not Available
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees, New Jersey 08043
United StatesSite Not Available
Long Island College Hospital
Brooklyn, New York 11201
United StatesSite Not Available
Roswell Park Cancer Institute
Buffalo, New York 14263-0001
United StatesSite Not Available
CCOP - North Shore University Hospital
Manhasset, New York 11030
United StatesSite Not Available
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Manhasset, New York 11030
United StatesSite Not Available
Long Island Jewish Medical Center
New Hyde Park, New York 11042
United StatesSite Not Available
Lenoir Memorial Cancer Center
Kinston, North Carolina 28501
United StatesSite Not Available
Rutherford Hospital
Rutherfordton, North Carolina 28139
United StatesSite Not Available
Bismarck Cancer Center
Bismarck, North Dakota 58501
United StatesSite Not Available
Cancer Care Center at Medcenter One Hospital
Bismarck, North Dakota 58501
United StatesSite Not Available
Mid Dakota Clinic, PC
Bismarck, North Dakota 58501
United StatesSite Not Available
St. Alexius Medical Center
Bismarck, North Dakota 58502
United StatesSite Not Available
Akron City Hospital
Akron, Ohio 44309-2090
United StatesSite Not Available
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio 44307
United StatesSite Not Available
CCOP - Dayton
Dayton, Ohio 45429
United StatesSite Not Available
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio 45409
United StatesSite Not Available
Good Samaritan Hospital
Dayton, Ohio 45406
United StatesSite Not Available
Grandview Hospital
Dayton, Ohio 45405
United StatesSite Not Available
Veterans Affairs Medical Center - Dayton
Dayton, Ohio 45428
United StatesSite Not Available
Blanchard Valley Medical Associates
Findlay, Ohio 45840
United StatesSite Not Available
Charles F. Kettering Memorial Hospital
Kettering, Ohio 45429
United StatesSite Not Available
Lima Memorial Hospital
Lima, Ohio 45804
United StatesSite Not Available
Northwest Ohio Oncology Center
Maumee, Ohio 43623
United StatesSite Not Available
Middletown Regional Hospital
Middletown, Ohio 45044
United StatesSite Not Available
St. Charles Mercy Hospital
Oregon, Ohio 43616
United StatesSite Not Available
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
Salem, Ohio 44460
United StatesSite Not Available
Firelands Regional Medical Center
Sandusky, Ohio 44870
United StatesSite Not Available
Flower Hospital Cancer Center
Sylvania, Ohio 43560
United StatesSite Not Available
CCOP - Toledo Community Hospital
Toledo, Ohio 43617
United StatesSite Not Available
Medical University of Ohio Cancer Center
Toledo, Ohio 43614
United StatesSite Not Available
St. Vincent Mercy Medical Center
Toledo, Ohio 43608
United StatesSite Not Available
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio 43623
United StatesSite Not Available
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio 45373-1300
United StatesSite Not Available
Cancer Treatment Center
Wooster, Ohio 44691
United StatesSite Not Available
United States Air Force Medical Center - Wright-Patterson
Wright-Patterson Afb, Ohio 45433-5529
United StatesSite Not Available
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio 45385
United StatesSite Not Available
Mercy Fitzgerald Hospital
Darby, Pennsylvania 19023
United StatesSite Not Available
Alle-Kiski Medical Center
Natrona Heights, Pennsylvania 15065
United StatesSite Not Available
Albert Einstein Cancer Center
Philadelphia, Pennsylvania 19141
United StatesSite Not Available
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania 19111-2497
United StatesSite Not Available
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania 19107-5541
United StatesSite Not Available
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
United StatesSite Not Available
AnMed Health Cancer Center
Anderson, South Carolina 29621
United StatesSite Not Available
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
CCOP - Upstate Carolina
Spartanburg, South Carolina 29303
United StatesSite Not Available
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina 29303
United StatesSite Not Available
Rapid City Regional Hospital
Rapid City, South Dakota 57701
United StatesSite Not Available
Medical X-Ray Center, PC
Sioux Falls, South Dakota 57105
United StatesSite Not Available
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota 57117-5039
United StatesSite Not Available
Cottonwood Hospital Medical Center
Murray, Utah 84107
United StatesSite Not Available
McKay-Dee Hospital Center
Ogden, Utah 84403
United StatesSite Not Available
Utah Valley Regional Medical Center - Provo
Provo, Utah 84604
United StatesSite Not Available
Dixie Regional Medical Center - East Campus
Saint George, Utah 84770
United StatesSite Not Available
Latter Day Saints Hospital
Salt Lake City, Utah 84143
United StatesSite Not Available
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah 84106
United StatesSite Not Available
Norris Cotton Cancer Center - North
Saint Johnsbury, Vermont 05819
United StatesSite Not Available
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia 26506
United StatesSite Not Available
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin 53792-6164
United StatesSite Not Available
Community Memorial Hospital Cancer Care Center
Menomonee Falls, Wisconsin 53051
United StatesSite Not Available
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin 53226
United StatesSite Not Available
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
Milwaukee, Wisconsin 53215
United StatesSite Not Available
All Saints Cancer Center at Wheaton Franciscan Healthcare
Racine, Wisconsin 53405
United StatesSite Not Available
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
Wausau, Wisconsin 54401
United StatesSite Not Available
West Allis Memorial Hospital
West Milwaukee, Wisconsin 53227
United StatesSite Not Available
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