Trial Outcomes & Findings for Cetuximab in Treating Patients With Precancerous Lesions of the Upper Aerodigestive Tract (NCT NCT00524017)

Results Overview

Histologic downgrade by at least one grade of dysplasia (e.g Severe to Moderate).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

8 weeks

Results posted on

2020-03-12

Study enrolled patients with premalignant lesions of the Head and Neck with mild, moderate or severe dysplasias

16 participants did not have biopsy proven dysplasia as required by protocol and were not randomized to treatment.

Participant milestones
Measure	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. cetuximab: given IV	Arm II (Control) Patients receive regular follow-up care
Overall Study STARTED	13	6
Overall Study COMPLETED	13	5
Overall Study NOT COMPLETED	0	1

Withdrawal data not reported

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

Baseline characteristics by cohort
Measure	Arm I (Treatment) n=13 Participants 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. cetuximab: given IV	Arm II (Control) n=6 Participants Patients receive regular follow-up care	Total n=19 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	13 Participants n=5 Participants	6 Participants n=7 Participants	19 Participants n=5 Participants

Timeframe: 8 weeks

Histologic downgrade by at least one grade of dysplasia (e.g Severe to Moderate).

Outcome measures
Measure	Arm I (Treatment) n=13 Participants 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. cetuximab: given IV	Arm II (Control) n=6 Participants Patients receive regular follow-up care
Number of Participants With Objective Response Based on Histologic Grade	13 Participants	6 Participants

Timeframe: 8 weeks

Clinical visualization on whether lesion responded to treatment (i.e., direct visualization of the lesion combined with histologic grade)

Outcome measures
Measure	Arm I (Treatment) n=13 Participants 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. cetuximab: given IV	Arm II (Control) n=6 Participants Patients receive regular follow-up care
Number of Participants With Objective Response Based on Clinical Assessment	13 Participants	6 Participants

Timeframe: Baseline (pre-treatment)

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

SKCCC

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