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

This study is currently recruiting participants.
Verified July 2013 by Comprehensive Cancer Center of Wake Forest University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01588613
First received: April 17, 2012
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention
Squamous Cell Carcinoma of the Skin
Stage I Squamous Cell Carcinoma of the Hypopharynx
Stage I Squamous Cell Carcinoma of the Larynx
Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage I Squamous Cell Carcinoma of the Oropharynx
Stage I Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Stage I Verrucous Carcinoma of the Larynx
Stage I Verrucous Carcinoma of the Oral Cavity
Stage II Squamous Cell Carcinoma of the Hypopharynx
Stage II Squamous Cell Carcinoma of the Larynx
Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage II Squamous Cell Carcinoma of the Oropharynx
Stage II Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Stage II Verrucous Carcinoma of the Oral Cavity
Drug: erlotinib hydrochloride
Procedure: therapeutic conventional surgery

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study to Evaluate the Anti-tumor Effect of Erlotinib Administered Before Surgery in Operable Patients With Squamous Cell Carcinoma of the Head and Neck (HNSCC)

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Correllation of tissue biomarkers with response to erlotinib [ Time Frame: day 1 to day 15 ] [ Designated as safety issue: No ]
    Estimate the correlation of the change in each biomarker with level of response, perform a series of 2-sample t-tests to determine which biomarkers exhibited a significant difference between responders and non-responders, the investigators will also examine whether the baseline measures of individual biomarkers are significantly predictive of subsequent response status. To do this the investigators will assess the correlation of the baseline biomarker and subsequent response outcome and perform 2-sample t-tests comparing the mean baseline biomarker values between responders and non-responders.


Secondary Outcome Measures:
  • Objective response, defined by CT scan measurements before and after treatment [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Change in tumor cell metabolic response measured by PET scan and correlation with tumor response by CT scan, PET, and direct tumor measurements [ Time Frame: From 4-6 days after beginning of treatment to end of treatment ] [ Designated as safety issue: No ]
  • Evaluate efficacy and utility of PET and CT scans in evaluating response to short-term treatment with erlotinib hydrochloride. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Evaluate efficacy and utility of PET and CT scans in evaluating response to short-term treatment with erlotinib hydrochloride by comparison of tumor response evaluation by PET scan with the same response evaluation performed by CT scan.

  • Correlate incidence of risk factors with relapse [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
    Evaluate incidence of risk factors for relapse in the surgical pathology specimen obtained at time of surgical treatment, such as: positive margins, extracapsular invasion, vessels and perineural invasion. Compare with historical data from published trials of patients treated with surgery with curative intent as initial treatment.

  • Incidence of adverse effects or significant laboratory changes during the administration of erlotinib hydrochloride [ Time Frame: Up to day 14 ] [ Designated as safety issue: Yes ]
  • Any treatment-induced delay of the established date for definitive surgical treatment [ Time Frame: Day 15 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: July 2008
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 (non-actively smoking patients)
Patients receive low dose erlotinib hydrochloride PO QD for at least 14 days. At day 15 patients undergo surgical resection of the tumor.
Drug: erlotinib hydrochloride
erlotinib hydrochloride given PO
Other Names:
  • CP-358,774
  • erlotinib
  • OSI-774
Procedure: therapeutic conventional surgery
Undergo resection
Experimental: Group 2 (actively smoking adults)
Patients receive high dose erlotinib hydrochloride PO QD for at least 14 days. At day 15 patients undergo surgical resection of the tumor.
Drug: erlotinib hydrochloride
erlotinib hydrochloride given PO
Other Names:
  • CP-358,774
  • erlotinib
  • OSI-774
Procedure: therapeutic conventional surgery
Undergo resection

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of Squamous Cell Carcinoma (SCC) of the Head and Neck: maxillary sinuses, oral cavity, oropharynx, hypopharynx, larynx, skin
  • Assessed to be candidates for surgical treatment and have an already established date for surgery with a window of opportunity of at least 15 days
  • Patients with SCC tumors will be eligible for this protocol only if they have additional biopsy tissue already saved in our Tumor Tissue Core Laboratory for research purpose or if they agree to have additional biopsies of tumor with adjacent normal tissue available for molecular studies
  • Patients will only be eligible for this trial if they have tumor measurable on the CT scan or magnetic resonance imaging (MRI)
  • No prior radiotherapy or chemotherapy for this tumor
  • No chemotherapy, biologic therapy or hormonotherapy within the last one year
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Absolute neutrophil count (ANC) > 1,500/ul
  • Platelet count > 100,000/ul
  • Total bilirubin < 1.5
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than 2 times the upper limit of normal
  • Written informed consent must be obtained from all subjects prior to beginning therapy (subjects should have the ability to understand and be willing to sign a written informed consent document)

Exclusion Criteria:

  • Patients with nasopharyngeal carcinoma
  • Patients receiving any other investigational agents
  • Patients who received prior treatment with EGFR inhibitors
  • Subjects with uncontrolled intercurrent illness including, but not limited to, 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, recent myocardial infarction [within prior 3 months], uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction)
  • Subject with a history of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on screening chest CT scan
  • Patients with clinically significant ophthalmologic abnormalities
  • Pregnant women are excluded; breastfeeding should be discontinued; men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control; subjects who are women of childbearing potential and sexually active males must be willing to use effective contraception while on study
  • Human immunodeficiency virus (HIV)-positive subjects are excluded from the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01588613

Locations
United States, North Carolina
University of North Carolina Health Care Not yet recruiting
Chapel Hill, North Carolina, United States, 27599-7600
Contact: Juneko E. Grilley-Olson    919-483-7828    juneko_grilley@med.unc.edu   
Principal Investigator: Juneko E. Grilley-Olson         
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Mercedes Porosnicu    336-713-4392    mporosni@wfubmc.edu   
Principal Investigator: Mercedes Porosnicu         
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Principal Investigator: Mercedes Porosnicu Comprehensive Cancer Center of Wake Forest University
  More Information

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT01588613     History of Changes
Other Study ID Numbers: CCCWFU 60307, NCI-2009-01255
Study First Received: April 17, 2012
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Nose Neoplasms
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Laryngeal Diseases
Carcinoma, Verrucous
Hypopharyngeal Neoplasms
Laryngeal Neoplasms
Skin Neoplasms
Carcinoma, Basal Cell
Carcinoma, Basosquamous
Paranasal Sinus Neoplasms
Oropharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Neoplasms
Skin Diseases
Neoplasms, Basal Cell
Nose Diseases
Paranasal Sinus Diseases
Erlotinib

ClinicalTrials.gov processed this record on April 22, 2014