NCT00524017 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2020-03-12

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Number of Participants With Objective Response Based on Histologic Grade

→

outcome · POSTED

Number of Participants With Objective Response Based on Clinical Assessment

→

outcome · POSTED

Status of Epidermal Growth Factor Receptor (EGFR) Pathway Components and Molecular Alterations in Pre-treatment Biopsies

→

outcome · POSTED

Status of EGFR Pathway Components and Molecular Alterations in Post-treatment Biopsies

→

outcome · POSTED

Survival

→

outcome · POSTED

Lesion Recurrence

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility Criteria: DISEASE CHARACTERISTICS: * Histologically confirmed high-risk, premalignant lesions of the upper aerodigestive tract, meeting one of the following criteria: * Unresectable, diffuse high-grade dysplasia, defined as moderate or severe dysplasia that is not assessable by physical examination and/or that cannot be excised by standard surgical techniques * previously treated HNSCC with persistent or recurrent high grade dysplasia with no evidence of head and neck malignancy for three months prior to enrollment or who have successfully completed therapy for head and neck malignancy more than 3 months prior to enrollment. * Dysplastic lesions with 3p or 9p loss of heterozygosity * Disease location amenable to endoscopic biopsy in an outpatient clinical setting or operative biopsy within the routine scheduling and practice of clinical care * No medical contraindication to biopsy of the target lesion * Pathology must be reviewed by the Johns Hopkins Hospital Department of Pathology PATIENT CHARACTERISTICS: * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Absolute neutrophil count (ANC) \> 1,000/mm³ * Platelet count \> 75,000/mm³ * Creatinine clearance \> 60 mL/min * Total serum bilirubin \< 1.5 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after completion of study therapy * No concurrent illness likely to preclude study therapy or surgical resection * Patients with a history of a curatively treated malignancy are eligible provided they are disease-free and have a survival prognosis that exceeds 5 years * No evidence of clinically active interstitial lung disease * Patients with chronic, stable radiographic changes who are asymptomatic are eligible * No history or radiological evidence of pulmonary fibrosis * No acute myocardial infarction within the past 3 months * No uncontrolled angina, arrhythmia, or congestive heart failure * No evidence of other severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) * No evidence of any other significant clinical disorder or laboratory finding that would preclude study participation * No known severe hypersensitivity to cetuximab or any of its excipients * No prior hypersensitivity reaction to chimerized or murine monoclonal antibody therapy * No severe abnormality of the cornea PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from prior oncologic or other major surgery or biopsy * More than 30 days since prior non-approved or investigational drugs * No prior chemotherapy, radiotherapy, or surgery for the premalignant lesions * No prior EGFR-targeted agents (e.g., cetuximab, gefitinib, or erlotinib)
healthy Volunteers: false
maximum Age: 120 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Biological: cetuximab
label
Arm I (treatment)
type
EXPERIMENTAL
description
Patients receive regular follow-up care
label
Arm II (control)
type
NO_INTERVENTION

interventions

arm Group Labels
Arm I (treatment)
description
given IV
name
cetuximab
type
BIOLOGICAL

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: DOUBLE
who Masked: PARTICIPANT
INVESTIGATOR

primary Purpose

TREATMENT

Enrollment

count: 35
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Histologic downgrade by at least one grade of dysplasia (e.g Severe to Moderate).
measure
Number of Participants With Objective Response Based on Histologic Grade
time Frame
8 weeks

secondary Outcomes

description
Clinical visualization on whether lesion responded to treatment (i.e., direct visualization of the lesion combined with histologic grade)
measure
Number of Participants With Objective Response Based on Clinical Assessment
time Frame
8 weeks
measure
Status of Epidermal Growth Factor Receptor (EGFR) Pathway Components and Molecular Alterations in Pre-treatment Biopsies
time Frame
Baseline (pre-treatment)
measure
Status of EGFR Pathway Components and Molecular Alterations in Post-treatment Biopsies
time Frame
At 8 weeks post-treatment
measure
Survival
time Frame
Up to year 5 years post-treatment
measure
Lesion Recurrence
time Frame
Up to year 5 years post-treatment

Full study description

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.

Source references

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-15972389fb4558359190
requested nct id
NCT00524017
primary nct id
NCT00524017
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Salivary+Gland+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
38e97f6c23d7b292911d062dea3fc0dffbdcbde03aae232fe8d067fdd28034c9
payload sha256
f38504715adc2fb10eaecaabc79fb27d42436c612cf77a3dc004df9c2b25d83b
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-15972389fb4558359190
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT00524017
occurrences
context exact
NCT00524017
end
11
exact text
NCT00524017
start
0
offset unit
unicode_code_points
query cond
Salivary Gland Cancer
query disease state id
ds-salivary-gland-cancer
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-salivary-gland-cancer-000.json
source file sha256
38e97f6c23d7b292911d062dea3fc0dffbdcbde03aae232fe8d067fdd28034c9
source json pointer
/studies/18/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
4ce22cdff99ecc3d64751c37228ba0ee688aeeac1a18516e5c789cc27eb13892
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Salivary+Gland+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-d8600ab086b2aedb275a
requested nct id
NCT00524017
primary nct id
NCT00524017
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Laryngeal+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
fd31a95088dd8ee475e2862bffd724180f0c754cf3f0e892cba5b448df424980
payload sha256
673098bd41daed60738c7ecf5cdad75494580544dde9cdada64c636a5591b838
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-d8600ab086b2aedb275a
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT00524017
occurrences
context exact
NCT00524017
end
11
exact text
NCT00524017
start
0
offset unit
unicode_code_points
query cond
Laryngeal Cancer
query disease state id
ds-laryngeal-cancer
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-laryngeal-cancer-000.json
source file sha256
fd31a95088dd8ee475e2862bffd724180f0c754cf3f0e892cba5b448df424980
source json pointer
/studies/33/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
4ce22cdff99ecc3d64751c37228ba0ee688aeeac1a18516e5c789cc27eb13892
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Laryngeal+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-d98537d39942b205df06
requested nct id
NCT00524017
primary nct id
NCT00524017
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Hypopharyngeal+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
cd92c144c33b33e75a38086ce6cbd6e62d34b7ba84c72dacac16e6781439e40e
payload sha256
5693907ffa5684ba199f4d62f8e353585f6fa28568ebffb21cf0c556fccef433
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-d98537d39942b205df06
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT00524017
occurrences
context exact
NCT00524017
end
11
exact text
NCT00524017
start
0
offset unit
unicode_code_points
query cond
Hypopharyngeal Cancer
query disease state id
ds-hypopharyngeal-cancer
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-hypopharyngeal-cancer-000.json
source file sha256
cd92c144c33b33e75a38086ce6cbd6e62d34b7ba84c72dacac16e6781439e40e
source json pointer
/studies/24/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
4ce22cdff99ecc3d64751c37228ba0ee688aeeac1a18516e5c789cc27eb13892
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Hypopharyngeal+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice