Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery
Head and Neck Cancer
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring recurrent squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the oropharynx, recurrent metastatic squamous neck cancer with occult primary, recurrent lymphoepithelioma of the oropharynx
Eligibility Criteria
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)
Sites / Locations
- University of Alabama at Birmingham Comprehensive Cancer Center
- Mobile Infirmary Medical Center
- St. Joseph's Mercy Cancer Center
- Auburn Radiation Oncology
- Radiation Oncology Centers - Cameron Park
- Mercy Cancer Center at Mercy San Juan Medical Center
- Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
- Radiation Oncology Center - Roseville
- Radiological Associates of Sacramento Medical Group, Incorporated
- University of California Davis Cancer Center
- Mercy General Hospital
- Solano Radiation Oncology Center
- Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center
- Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
- University of Florida Shands Cancer Center
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
- CCOP - Mount Sinai Medical Center
- University of Miami Sylvester Comprehensive Cancer Center
- H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
- MBCCOP - Medical College of Georgia Cancer Center
- Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
- Saint Anthony's Hospital at Saint Anthony's Health Center
- Rush-Copley Cancer Care Center
- Joliet Oncology-Hematology Associates, Limited - West
- Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
- Cancer Institute at St. John's Hospital
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- St. John's Cancer Center at St. John's Medical Center
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Elkhart General Hospital
- Indiana University Cancer Center
- Howard Community Hospital at Howard Regional Health System
- Center for Cancer Therapy at LaPorte Hospital and Health Services
- Saint Anthony Memorial Health Centers
- Reid Hospital & Health Care Services, Incorporated
- CCOP - Northern Indiana CR Consortium
- Memorial Hospital of South Bend
- Feist-Weiller Cancer Center at Louisiana State University Health Sciences
- MaineGeneral Medical Center - Waterville Campus
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Hickman Cancer Center at Bixby Medical Center
- University of Michigan Comprehensive Cancer Center
- Barbara Ann Karmanos Cancer Institute
- Breslin Cancer Center at Ingham Regional Medical Center
- Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
- Saint Francis Medical Center
- Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
- David C. Pratt Cancer Center at St. John's Mercy
- Siteman Cancer Center at Barnes-Jewish Hospital
- CCOP - St. Louis-Cape Girardeau
- CCOP - Montana Cancer Consortium
- Northern Rockies Radiation Oncology Center
- Deaconess Billings Clinic - Downtown
- Methodist Cancer Center at Methodist Hospital - Omaha
- CCOP - Nevada Cancer Research Foundation
- Kingsbury Center for Cancer Care at Cheshire Medical Center
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
- J. Phillip Citta Regional Cancer Center at Community Medical Center
- Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
- Fox Chase Virtua Health Cancer Program at Virtua West Jersey
- Long Island College Hospital
- Roswell Park Cancer Institute
- CCOP - North Shore University Hospital
- Don Monti Comprehensive Cancer Center at North Shore University Hospital
- Long Island Jewish Medical Center
- Lenoir Memorial Cancer Center
- Rutherford Hospital
- Bismarck Cancer Center
- Cancer Care Center at Medcenter One Hospital
- Mid Dakota Clinic, PC
- St. Alexius Medical Center
- McDowell Cancer Center at Akron General Medical Center
- Akron City Hospital
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Blanchard Valley Medical Associates
- Charles F. Kettering Memorial Hospital
- Lima Memorial Hospital
- Northwest Ohio Oncology Center
- Middletown Regional Hospital
- St. Charles Mercy Hospital
- Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
- Firelands Regional Medical Center
- Flower Hospital Cancer Center
- St. Vincent Mercy Medical Center
- Medical University of Ohio Cancer Center
- CCOP - Toledo Community Hospital
- Toledo Clinic, Incorporated - Main Clinic
- UVMC Cancer Care Center at Upper Valley Medical Center
- Cancer Treatment Center
- United States Air Force Medical Center - Wright-Patterson
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Mercy Fitzgerald Hospital
- Alle-Kiski Medical Center
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
- Fox Chase Cancer Center - Philadelphia
- Albert Einstein Cancer Center
- Allegheny Cancer Center at Allegheny General Hospital
- AnMed Health Cancer Center
- Hollings Cancer Center at Medical University of South Carolina
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- Rapid City Regional Hospital
- Medical X-Ray Center, PC
- Sioux Valley Hospital and University of South Dakota Medical Center
- Cottonwood Hospital Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center - Provo
- Dixie Regional Medical Center - East Campus
- Utah Cancer Specialists at UCS Cancer Center
- Latter Day Saints Hospital
- Norris Cotton Cancer Center - North
- Mary Babb Randolph Cancer Center at West Virginia University Hospitals
- University of Wisconsin Comprehensive Cancer Center
- Community Memorial Hospital Cancer Care Center
- Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
- Medical College of Wisconsin Cancer Center
- All Saints Cancer Center at Wheaton Franciscan Healthcare
- University of Wisconcin Cancer Center at Aspirus Wausau Hospital
- West Allis Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Other
Other
Radiotherapy and chemotherapy
Chemotherapy
Radiotherapy/paclitaxel/cisplatin/filgrastim
Cisplatin/fluorouracil/paclitaxel/docetaxel