Chemotherapy and Radiation Therapy (RT) With or Without Vandetanib in Treating Patients With High-Risk Stage III or Stage IV Head and Neck Cancer
- Conditions
- Head and Neck Cancer
- Interventions
- Registration Number
- NCT00720083
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving chemotherapy together with radiation therapy is more effective with or without vandetanib in treating patients with head and neck cancer.
PURPOSE: This randomized phase II trial is studying giving chemotherapy together with radiation therapy to see how well it works compared with giving chemotherapy and radiation therapy together with vandetanib in treating patients with high-risk stage III or stage IV head and neck cancer.
- Detailed Description
OBJECTIVES:
Primary
* To screen for an indication that the addition of vandetanib to chemoradiotherapy may prolong disease-free survival as compared to a combination of chemoradiotherapy in patients with resected, high-risk stage III or IV head and neck squamous cell carcinoma.
Secondary
* To determine whether this treatment regimen can be delivered safely and successfully following surgical resection for advanced head and neck cancer.
* To estimate the locoregional progression, distant metastasis, and overall survival rates for patients treated with this regimen.
* To examine the distribution of selected biomarkers that may include but are not limited to EGFR (epidermal growth factor receptor, total and phosphorylated), E-cadherin, pMAPK (phosphorylated mitogen-activated protein kinase), pAKT, Stat-3 (signal transducer and activator of transcription 3), Ki-67, COX-2 (cyclooxygenase 2), and cyclin B1 (G2/mitotic-specific cyclin-B1)expression in this group of patients and to explore the potential correlation between these markers with the ultimate treatment outcome
OUTLINE: This is a multicenter study. Patients are stratified according to Zubrod performance status (0 vs 1) and primary site of disease (oral cavity/hypopharynx vs larynx vs oropharynx, HPV+ (human papillomavirus positive) vs oropharynx, HPV- (human papillomavirus negative)). Patients are randomized to 1 of 2 arms.
* Arm I: Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
* Arm II: Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy.
In both arms, treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
Tissue samples from all patients are collected and reviewed. Tissue from patients with oropharyngeal carcinoma is analyzed for human papillomavirus.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 4 years, and then annually thereafter.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 34
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RT + Cisplatin cisplatin Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. RT + Cisplatin radiation therapy Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. RT + Cisplatin + Vandetanib radiation therapy Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. RT + Cisplatin + Vandetanib cisplatin Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. RT + Cisplatin + Vandetanib vandetanib Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
- Primary Outcome Measures
Name Time Method Disease-free Survival From randomization to date of failure (local, regional, or distant progression, or death) or last follow-up. Analysis occurs after 78 failures have been reported. This study terminated early with 34 subjects accrued out of 170 planned, therefore no analyses were performed.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (63)
Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States
Fox Chase Cancer Center - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
York Cancer Center at Apple Hill Medical Center
🇺🇸York, Pennsylvania, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Saint Elizabeth Cancer Institute at Saint Elizabeth Regional Medical Center
🇺🇸Lincoln, Nebraska, United States
Charach Cancer Center at Huron Valley - Sinai Hospital
🇺🇸Commerce, Michigan, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Cancer Institute at St. John's Hospital
🇺🇸Springfield, Illinois, United States
Josephine Ford Cancer Center at Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Lake/University Ireland Cancer Center
🇺🇸Mentor, Ohio, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸Commack, New York, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
University of New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Summa Center for Cancer Care at Akron City Hospital
🇺🇸Akron, Ohio, United States
Memorial Sloan-Kettering Cancer Center - Rockville Centre
🇺🇸Rockville Centre, New York, United States
Truman Medical Center - Hospital Hill
🇺🇸Kansas City, Missouri, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
University of Virginia Cancer Center
🇺🇸Charlottesville, Virginia, United States
Renown Institute for Cancer at Renown Regional Medical Center
🇺🇸Reno, Nevada, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
🇺🇸Reading, Pennsylvania, United States
Geisinger Cancer Institute at Geisinger Health
🇺🇸Danville, Pennsylvania, United States
Fox Chase Cancer Center Buckingham
🇺🇸Furlong, Pennsylvania, United States
Memorial Sloan-Kettering Cancer Center - Basking Ridge
🇺🇸Basking Ridge, New Jersey, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
Leo W. Jenkins Cancer Center at ECU Medical School
🇺🇸Greenville, North Carolina, United States
Oklahoma University Cancer Institute
🇺🇸Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Milwaukee
🇺🇸Milwaukee, Wisconsin, United States
Regional Cancer Center at Oconomowoc Memorial Hospital
🇺🇸Oconomowoc, Wisconsin, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Virginia Commonwealth University Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Waukesha Memorial Hospital Regional Cancer Center
🇺🇸Waukesha, Wisconsin, United States
Methodist Cancer Center at Methodist Hospital
🇺🇸Indianapolis, Indiana, United States
M. D. Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
David C. Pratt Cancer Center at St. John's Mercy
🇺🇸Saint Louis, Missouri, United States
Medical College of Wisconsin Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Radiological Associates of Sacramento Medical Group, Incorporated
🇺🇸Sacramento, California, United States
Winship Cancer Institute of Emory University
🇺🇸Altanta, Georgia, United States
James Graham Brown Cancer Center at University of Louisville
🇺🇸Louisville, Kentucky, United States
Saint John's Cancer Center at Saint John's Medical Center
🇺🇸Anderson, Indiana, United States
Ingalls Cancer Care Center at Ingalls Memorial Hospital
🇺🇸Harvey, Illinois, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Regional Cancer Center at Singing River Hospital
🇺🇸Pascagoula, Mississippi, United States
Radiation Oncology Associates, PA
🇺🇸Albuquerque, New Mexico, United States
Highland Hospital of Rochester
🇺🇸Rochester, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
🇺🇸Sleepy Hollow, New York, United States
North Coast Cancer Care, Incorporated
🇺🇸Sandusky, Ohio, United States
Flower Hospital Cancer Center
🇺🇸Sylvania, Ohio, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Sentara Cancer Institute at Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Schiffler Cancer Center at Wheeling Hospital
🇺🇸Wheeling, West Virginia, United States
Gundersen Lutheran Center for Cancer and Blood
🇺🇸La Crosse, Wisconsin, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Bay Area Cancer Care Center at Bay Area Medical Center
🇺🇸Marinette, Wisconsin, United States
Barberton Citizens Hospital
🇺🇸Barberton, Ohio, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States