NCT00524017

Cetuximab in Treating Patients With Precancerous Lesions of the Upper Aerodigestive Tract

Phase II Study of Single-Agent Cetuximab for Treatment of High-Risk Pre-malignant Upper Aerodigestive Lesions

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Cancer
• Precancerous Condition

Interventions

Type	Name	Description
BIOLOGICAL	cetuximab	given IV

Timeline

• Start date: 2007-05-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2007-09-03
• Last updated: 2020-03-12
• Results posted: 2020-03-12

Locations

10 sites across 2 countries: United States, Canada