Cisplatin, Bevacizumab, and Intensity-Modulated Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00423930|
Recruitment Status : Completed
First Posted : January 18, 2007
Results First Posted : August 18, 2017
Last Update Posted : August 18, 2017
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. Monoclonal antibodies, such as bevacizumab, 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. Bevacizumab may also stop the growth of head and neck cancer by blocking blood flow to the tumor. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving cisplatin and bevacizumab together with intensity-modulated radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving cisplatin and bevacizumab together with intensity-modulated radiation therapy works in treating patients with stage III or stage IV head and neck cancer.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Biological: bevacizumab Drug: cisplatin Procedure: conventional surgery Radiation: intensity-modulated radiation therapy||Phase 2|
- Determine the 2-year progression-free survival of patients with stage III or IV squamous cell carcinoma of the head and neck treated with chemoradiotherapy comprising cisplatin, bevacizumab, and intensity-modulated radiotherapy.
- Determine the safety and tolerability of this regimen in these patients.
- Determine the median overall survival of patients treated with this regimen.
- Chemoradiotherapy: Patients receive cisplatin IV over 1 hour on days 1, 2, 22, 23, 43, and 44 and bevacizumab IV over 30-90 minutes on days 1, 22, and 43. Patients also undergo intensity-modulated radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47. Treatment continues in the absence of disease progression or unacceptable toxicity.
Between 3-4 months after completion of chemoradiotherapy, patients undergo evaluation. Patients with clinical evidence of residual, progressive, or persistent disease may be eligible to undergo neck surgery at the discretion of their physician.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Radiotherapy (IMRT) + Cisplatin + Bevacizumab for Patients With Stage III/IV Head and Neck Cancers|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
Experimental: IMRT + cisplatin + bevacizumab
This is a single-institution phase II study. The primary endpoint is to determine 2-year progression-free survival for patients with locally or regionally advanced HNSCC treated with concurrent intensity modulated radiation therapy (IMRT) + cisplatin + bevacizumab.
|Biological: bevacizumab Drug: cisplatin Procedure: conventional surgery Radiation: intensity-modulated radiation therapy|
- Progression-free Survival at 2 Years [ Time Frame: Percentage of Participants Experiencing Progression-free Survival at 2 Years ]Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- Overall Survival Rate: Percentage of Participants Who Survived [ Time Frame: 2 years ]
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): NCT00423930
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||David G. Pfister, MD||Memorial Sloan Kettering Cancer Center|