Cetuximab in Treating Patients With Precancerous Lesions of the Upper Aerodigestive Tract
- Conditions
- Head and Neck CancerPrecancerous Condition
- Interventions
- Biological: cetuximab
- Registration Number
- NCT00524017
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
Primary
* To determine the histologic response rate in patients with high-risk, premalignant lesions of the upper aerodigestive tract treated with cetuximab.
Secondary
* To determine the clinical response rate in these patients.
* To determine if patterns of epidermal growth factor receptor (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 immuno-histochemistry (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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I (treatment) cetuximab 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.
- Primary Outcome Measures
Name Time Method Number of Participants With Objective Response Based on Histologic Grade 8 weeks Histologic downgrade by at least one grade of dysplasia (e.g Severe to Moderate).
- Secondary Outcome Measures
Name Time Method Survival Up to year 5 years post-treatment Status of Epidermal Growth Factor Receptor (EGFR) Pathway Components and Molecular Alterations in Pre-treatment Biopsies Baseline (pre-treatment) Status of EGFR Pathway Components and Molecular Alterations in Post-treatment Biopsies At 8 weeks post-treatment Lesion Recurrence Up to year 5 years post-treatment Number of Participants With Objective Response Based on Clinical Assessment 8 weeks Clinical visualization on whether lesion responded to treatment (i.e., direct visualization of the lesion combined with histologic grade)
Trial Locations
- Locations (10)
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Greenebaum Cancer Center at University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
UPMC Cancer Centers
🇺🇸Pittsburgh, Pennsylvania, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Lucille P. Markey Cancer Center at University of Kentucky
🇺🇸Lexington, Kentucky, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
NYU Cancer Institute at New York University Medical Center
🇺🇸New York, New York, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
British Columbia Cancer Agency - Vancouver Cancer Centre
🇨🇦Vancouver, British Columbia, Canada