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

NCT00601913 | Completed Early Phase 1 DMC FDA Drug

• 3 other identifiers: IRB00004038P30CA012197CCCWFU-60307
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Cancer

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

Outcome Measures

Primary Outcomes (1)

• 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 (6)

• 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

Study Arms (1)

Erlotinib

EXPERIMENTAL

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

erlotinib hydrochloride DRUG

Erlotinib

protein analysis GENETIC

Erlotinib

western blotting GENETIC

Erlotinib

immunohistochemistry staining method OTHER

Erlotinib

laboratory biomarker analysis OTHER

Erlotinib

liquid chromatography OTHER

Erlotinib

mass spectrometry OTHER

Erlotinib

neoadjuvant therapy PROCEDURE

Erlotinib

therapeutic conventional surgery PROCEDURE

Erlotinib

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Related Publications (1)

• 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.

  PMID: 36110959 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Erlotinib Hydrochloride; Blotting, Western; Immunohistochemistry; Chromatography, Liquid; Mass Spectrometry; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Electrophoresis; Chemistry Techniques, Analytical; Investigative Techniques; Electrochemical Techniques; Immunoblotting; Immunoassay; Immunologic Techniques; Molecular Probe Techniques; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Chromatography; Combined Modality Therapy; Therapeutics

Study Officials

• Mercedes Porosnicu, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• J. D. Browne, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2008
• First Posted: January 28, 2008
• Study Start: March 1, 2008
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: July 5, 2018

Record last verified: 2018-07

Locations

US (1)