CompletedNCT00601913Updated Jul 5, 2018

Erlotinib and Surgery in Treating Patients With Head and Neck Cancer That Can Be Removed by Surgery

An Early Phase 1 interventional study of erlotinib hydrochloride and protein analysis in Head and Neck Cancer, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2018-07-05.

Sponsored by Wake Forest University Health Sciences · Early Phase 1, Interventional, and Treatment

From the registry’s dates

Primary completion was Oct 2014, 12 years ago, and no results have been posted to the registry.

Phase: Early Phase 1
Study type: Interventional
Enrollment: 24
Allocation: Not applicable
Ages: 18 Years to 120 Years
Sex: All

Study summary

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment with erlotinib.

PURPOSE: This clinical trial is studying how well erlotinib works when given before surgery in treating patients with head and neck cancer that can be removed by surgery.

Read the detailed description

OBJECTIVES:

Primary

Identify tissue biomarkers (primarily the level of phosphorylation of individual C-terminal EGFR tyrosine sites, measured by nano-LC-MS/MS and markers of main downstream pathways activation such as P-AKT and P-ERK, measured by nano-LC-MS/MS and by more clinically standardized IHC) that best associate with response to neoadjuvant erlotinib hydrochloride treatment in patients with resectable squamous cell carcinoma of the head and neck (HNSCC).
Determine the best correlations between levels and changes of different individual biomarkers (e.g., levels of C-terminal EGFR phosphorylation and recruited adaptors and markers of downstream pathways activation) in order to evaluate the mechanisms of EGFR pathway activation in HNSCC and mechanisms of EGFR pathway inhibition by erlotinib hydrochloride in HNSCC tissue.
Evaluate post-erlotinib hydrochloride up-regulation of different receptors and molecules such as HER2 and 3, PDGFR, IGFR, mTOR, src, and aurora kinases, for which there are already specific inhibitors available for clinical studies.

Secondary

Evaluate the efficacy by overall response, safety, and tolerability of erlotinib hydrochloride before surgery in these patients.
Evaluate the role of FDG-PET scan as a predictor of response to erlotinib hydrochloride.
Evaluate the role of PET/CT in measuring the response to short-term treatment with erlotinib hydrochloride.
Evaluate incidence of risk factors for relapse in the surgical pathology specimens.

OUTLINE: Patients are grouped according to smoking status (non-actively smoking [not smoking, smoking an average of \< 10 cigarettes daily, or smoking for \< 1 year prior to enrollment] vs actively smoking [smoking an average of ≥ 10 cigarettes daily and smoking for ≥ 1 year]).

Non-actively smoking patients: Patients receive oral erlotinib hydrochloride 150 mg once daily for at least 14 days. At day 15 patients undergo surgical resection of the tumor.
Actively smoking patients: Patients receive oral erlotinib hydrochloride 300 mg once daily for at least 14 days. At day 15 patients undergo surgical resection of the tumor.

Patients undergo biopsies at baseline and after completion of study treatment. Tissue samples are analyzed by nano-liquid chromatography and mass spectrometry (nano-LC-MS/MS) for markers of activation and inhibition of different EGFR downstream pathways: PKC, c-Cbl, P-Erk, P- Akt, P-RAF, src, STAT3 and 5, cyclin D1, and D3, p21 and p27, c-fos, E-cadherin, vimentin, and correlative up-regulated receptors: Her 2, Her 3, Cox-2, IGF, VEGF, PDGFR, or other kinases such as src and aurora kinases A and B. The results are confirmed by western blot, protein array, and immunohistochemistry.

After completion of study treatment, patients are followed at 1 month.

Conditions studied

Head and Neck Cancer

Browse trials for

Head and Neck Neoplasms 2,344

Keywords

stage I squamous cell carcinoma of the oropharynx
stage II squamous cell carcinoma of the oropharynx
stage I squamous cell carcinoma of the larynx
stage II squamous cell carcinoma of the larynx
stage I squamous cell carcinoma of the lip and oral cavity
stage II squamous cell carcinoma of the lip and oral cavity
stage I squamous cell carcinoma of the hypopharynx
stage II squamous cell carcinoma of the hypopharynx
stage I verrucous carcinoma of the larynx
stage I verrucous carcinoma of the oral cavity
stage II verrucous carcinoma of the oral cavity

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

This study's enrollment of 24 is below the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 120 Years
Sexes eligible: All
Accepts healthy volunteers: No

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed squamous cell carcinoma (SCC) of the oral cavity, oropharynx, hypopharynx, or larynx
- SCC of the base of the tongue, pharynx, larynx, or hypopharynx are eligible provided additional biopsy tissue has been already saved in the Tumor Tissue Core Laboratory for research purposes
- SCC of the oral cavity or tonsils are eligible only if they already have or agree to have additional biopsies of tumor with adjacent normal tissue available for molecular studies
Candidate for surgical treatment with an established date for surgery with ≥ a 15 day window of opportunity
Measurable disease by CT scan or MRI
No nasopharyngeal carcinoma

PATIENT CHARACTERISTICS:

Inclusion criteria

Inclusion criteria:

ECOG performance status 0-2
ANC > 1,500/µL
Platelet count > 100,000/µL
Total bilirubin \< 1.5 mg/dL
AST/ALT \< 2 times upper limit of normal
Creatinine \< 1.5 mg/dL
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

Exclusion criteria

Exclusion criteria:

Uncontrolled intercurrent illness including, but not limited to, any of the following:
- Ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
- Significant history of uncontrolled cardiac disease (i.e., uncontrolled hypertension, unstable angina, or myocardial infarction within the past 3 months)
- Uncontrolled congestive heart failure
- Cardiomyopathy with decreased ejection fraction
History of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on chest CT scan
Clinically significant ophthalmologic abnormalities
HIV positivity

PRIOR CONCURRENT THERAPY:

More than 1 year since prior chemotherapy, biologic therapy, or hormonal therapy
No prior radiotherapy or chemotherapy for this tumor
No prior EGFR inhibitors
No concurrent grapefruit or grapefruit juice
No other concurrent investigational agents

Study design

Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 24 participants (actual)

Study arms

Experimental
Erlotinib
Erlotinib
Drug: erlotinib hydrochloride · Genetic: protein analysis · Genetic: western blotting · Other: immunohistochemistry staining method · Other: laboratory biomarker analysis · Other: liquid chromatography · Other: mass spectrometry · Procedure: neoadjuvant therapy · Procedure: therapeutic conventional surgery

Interventions

Drugerlotinib hydrochloride
Geneticprotein analysis
Geneticwestern blotting
Otherimmunohistochemistry staining method
Otherlaboratory biomarker analysis
Otherliquid chromatography
Othermass spectrometry
Procedureneoadjuvant therapy
Proceduretherapeutic conventional surgery

What researchers measure

Primary outcomes

Identify tissue biomarkers of EGFR activation and inhibition for which initial values and changes after treatment with erlotinib hydrochloride would best correlate with the objective response of the tumor measured clinically and radiologically

Secondary outcomes

Objective response
Tumor cell metabolic response measured by PET scan at 4-6 days after beginning of treatment and correlation with tumor response evaluated at the end of treatment by CT scan, PET scan, and direct tumor measurements
Role of PET/CT scan in evaluating response to short-term treatment with erlotinib hydrochloride and comparison with the same response evaluation performed by CT scan
Incidence of risk factors for relapse
Incidence of adverse effects or significant laboratory changes
Any treatment-induced delay of the established date for definitive surgical treatment

Study locations

1 site

Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina 27157-1096, United States

References and documents

Publications

Porosnicu M, O'Brien Cox A, Waltonen JD, Bunch PM, D'Agostino R, Lycan TW, Taylor R, Williams DW 3rd, Chen X, Shukla K, Kouri BE, Walker T, Kucera G, Patwa HS, Sullivan CA, Browne JD, Furdui CM. Early [18]FDG PET/CT scan predicts tumor response in head and neck squamous cell cancer patients treated with erlotinib adjusted per smoking status. Front Oncol. 2022 Aug 30;12:939118. doi: 10.3389/fonc.2022.939118. eCollection 2022. PubMed 36110959 ↗

Individual participant data

Plan to share: Undecided

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00601913
Lead sponsor: Wake Forest University Health Sciences
Collaborators: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Jan 28, 2008
Start date: Mar 2008
Primary completion: Oct 2014
Completion: Oct 2014
Last update: Jul 5, 2018

Study contacts

Mercedes Porosnicu, MD

principal investigator · Wake Forest University Health Sciences

J. D. Browne, MD

principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Head and Neck Neoplasms→

Other studies from this sponsor

Wake Forest University Health Sciences

Start the discussion