Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. 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. Giving cetuximab and cisplatin together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab and cisplatin together with radiation therapy works in treating patients with recurrent head and neck cancer.
Head and Neck Cancer
Radiation: intensity-modulated radiation therapy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Multi-Center Study of Concomitant Cetuximab and Cisplatin With Re-Irradiation Using Intensity-Modulated Radiotherapy in Patients With Recurrent Squamous Cell Carcinoma of the Head-and-Neck|
- crude survival [ Time Frame: one year ] [ Designated as safety issue: No ]1-year crude survival
- progression-free survival and local-regional progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]1-year progression-free survival and local-regional progression
- acute and late toxicities [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]Incidence rate of acute and late toxicities
- disease progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]Pattern of disease progression
- Response [ Time Frame: 2 years ] [ Designated as safety issue: No ]tumor response
|Study Start Date:||December 2008|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: arm one
Cetuximab, Cisplatin, and Radiation Therapy
cisplatinRadiation: intensity-modulated radiation therapy
Other Name: IMRT
- To evaluate whether treatment with cetuximab, cisplatin, and intensity-modulated radiotherapy improves the overall survival of patients with recurrent squamous cell carcinoma of the head and neck.
- To determine the progression-free survival and local-regional progression in these patients.
- To identify and estimate the incidence rate of acute and late toxicities associated with this treatment regimen.
- To determine the pattern of disease progression in these patients.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-7. Patients also receive cisplatin IV over 60 minutes once weekly and undergo intensity-modulated radiotherapy once daily 5 days a week in weeks 2-7.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 4 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00833261
|United States, Ohio|
|University Hospitals of Cleveland|
|Cleveland, Ohio, United States, 44106|
|United States, Texas|
|Baylor Research Institute|
|Dallas, Texas, United States, 75204|
|University of Texas Southwestern Medical Center - Dallas|
|Dallas, Texas, United States, 75390|
|United States, Wisconsin|
|Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Lucien A. Nedzi, MD||Simmons Cancer Center|