Cetuximab in Treating Patients With Precancerous Lesions of the Upper Aerodigestive Tract
|ClinicalTrials.gov Identifier: NCT00524017|
Recruitment Status : Completed
First Posted : September 3, 2007
Last Update Posted : January 31, 2012
RATIONALE: Monoclonal antibodies, such as cetuximab, can block abnormal cell growth in different ways. Some block the ability of abnormal cells to grow and spread. Others find abnormal cells and help kill them or carry cell-killing substances to them.
PURPOSE: This randomized phase II trial is studying how well cetuximab works in treating patients with precancerous lesions of the upper aerodigestive tract.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Precancerous Condition||Biological: cetuximab Procedure: standard follow-up care||Phase 2|
- To determine the histologic response rate in patients with high-risk, premalignant lesions of the upper aerodigestive tract treated with cetuximab.
- To determine the clinical response rate in these patients.
- To determine if patterns of EGFR component expression are altered in these patients.
- To determine the change in status of genetic alterations, including loss of heterozygosity, in these patients.
OUTLINE: This is a multicenter study. Patients are stratified by lesion type (diffuse dysplasia vs recurrent dysplasia vs dysplastic lesions with 3p or 9p loss of heterozygosity [LOH]). Patients are randomized to 1 of 2 arms.
- Arm I (treatment): Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, 36, 43, and 50 in the absence of disease progression or unacceptable toxicity.
- Arm II (control): Patients receive regular follow-up care. Patients have the option of receiving cetuximab after completion of the study.
In both arms, patients with persistent or recurrent high-grade dysplasia or dysplastic lesions with 3p or 9p LOH undergo surgical resection, if feasible, after week 8.
Tumor biopsy samples are obtained at baseline* and after week 8 for histologic and biomarker correlative studies. Tissue samples are analyzed by histopathology to determine histologic changes in post-treatment lesions and by IHC to measure expression and activation of EGFR signaling pathway components. LOH studies are also performed.
NOTE: *Paraffin-embedded tissue from the original diagnostic biopsy may be used for baseline assessment, if the diagnostic biopsy was performed within 3 months prior to study entry.
After completion of study therapy, patients are followed at approximately 1 month, every 3 months for 2 years, and then every 6 months for up to 5 years as per routine standard of care.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Phase II Study of Single-Agent Cetuximab for Treatment of High-Risk Pre-malignant Upper Aerodigestive Lesions|
|Study Start Date :||May 2007|
|Primary Completion Date :||December 2011|
|Study Completion Date :||December 2011|
Experimental: Arm I (treatment)
Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, 36, 43, and 50 in the absence of disease progression or unacceptable toxicity.
No Intervention: Arm II (control)
Patients receive regular follow-up care
Procedure: standard follow-up care
Patients receive regular follow-up care
- Objective response based on histologic grade [ Time Frame: End of Treatment of Observation ]
- Objective response based on clinical assessment (i.e., direct visualization of the lesion combined with histologic grade) [ Time Frame: End of Treatment of Observation ]
- Status of EGFR pathway components and molecular alterations in pre- and post-treatment biopsies [ Time Frame: End of Treatment of Observation ]
- Survival and lesion recurrence [ Time Frame: Up to year 5 after Treatment on Trial ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00524017
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, Kentucky|
|Lucille P. Markey Cancer Center at University of Kentucky|
|Lexington, Kentucky, United States, 40536-0093|
|United States, Maryland|
|Greenebaum Cancer Center at University of Maryland Medical Center|
|Baltimore, Maryland, United States, 21201|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109-0942|
|United States, New York|
|NYU Cancer Institute at New York University Medical Center|
|New York, New York, United States, 10010|
|United States, Pennsylvania|
|UPMC Cancer Centers|
|Pittsburgh, Pennsylvania, United States, 15232|
|United States, South Carolina|
|Hollings Cancer Center at Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Canada, British Columbia|
|British Columbia Cancer Agency - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Study Chair:||Joseph Califano, MD||Sidney Kimmel Comprehensive Cancer Center|