Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT00833261|
Recruitment Status : Unknown
Verified May 2014 by University of Texas Southwestern Medical Center.
Recruitment status was: Active, not recruiting
First Posted : February 2, 2009
Last Update Posted : March 20, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: cetuximab Drug: cisplatin Radiation: intensity-modulated radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2008|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
Experimental: arm one
Cetuximab, Cisplatin, and Radiation Therapy
cisplatinRadiation: intensity-modulated radiation therapy
Other Name: IMRT
- crude survival [ Time Frame: one year ]1-year crude survival
- progression-free survival and local-regional progression [ Time Frame: 1 year ]1-year progression-free survival and local-regional progression
- acute and late toxicities [ Time Frame: 6 month ]Incidence rate of acute and late toxicities
- disease progression [ Time Frame: 1 year ]Pattern of disease progression
- Response [ Time Frame: 2 years ]tumor response
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|