Erlotinib Prior to Surgery in Patients With Head and Neck Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
OSI Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00954226
First received: August 6, 2009
Last updated: June 14, 2013
Last verified: June 2013
  Purpose

The goal of this clinical research study is to learn the effects of the standard dose of erlotinib and the higher dose of erlotinib on biomarker levels in patients with head and neck cancer. Biomarkers are chemical "markers" in the blood and/or tissue that may be related to your response to the study drug. The safety of the drug will also be studied.

Objectives:

To determine the molecular effects and safety of erlotinib 150 mg/day (standard dose) and 200 mg/day or 300 mg/day (high-dose) in patients with head and neck cancer who are planned for surgery.

Primary Objective:

To determine the effects of erlotinib 150 mg/day (standard dose) and 200 mg/day or 300 mg/day (high-dose) on the phosphorylation of AKT protein downstream from EGFR.

Secondary Objectives:

  1. To assess the safety and tolerability of erlotinib 150 mg/day (standard dose) and 200 mg/day or 300 mg/day (high-dose).
  2. To correlate the effects of erlotinib on the phosphorylation of AKT with the immunohistochemical expression level of EGFR and the level of amplification of the EGFR gene as determined by fluorescent in situ hybridization (FISH).
  3. To evaluate the preliminary response rate with a short course of erlotinib.
  4. To evaluate changes in the activation status of proteins downstream from EGFR and other receptor tyrosine kinases and in markers of epithelial to mesenchymal transition.
  5. To evaluate changes in blood-based biomarkers.
  6. To evaluate the effects of a higher dose of erlotinib (300 mg/day) in current smokers.

Condition Intervention Phase
Head And Neck Cancer
Drug: Erlotinib
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase Ib Study of Erlotinib Prior to Surgery in Patients With Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Effects of erlotinib 150 mg/day (standard dose) + 200 mg/day or 300 mg/day (high-dose) on phosphorylation of AKT protein downstream from EGFR [ Time Frame: Treatment: 2-3 week period leading up to surgery; Disease reassessment (Imaging studies): 1 week before surgery. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 55
Study Start Date: August 2009
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Standard Dose Erlotinib
Standard Dose: 1 tablet of 150 mg erlotinib once a day, every day leading up to surgery.
Drug: Erlotinib

Standard Dose: 1 tablet of 150 mg erlotinib once a day, every day leading up to surgery.

Higher Dose: 200 mg or 300 mg in 2 tablets once a day, every day leading up to surgery.

Depending on your assigned dose level, the 2 tablets may contain the same drug amount or 2 different drug amounts.

Other Names:
  • Erlotinib Hydrochloride
  • OSI-774
  • Tarceva
Experimental: Higher Dose Erlotinib
Higher Dose: 200 mg or 300 mg in 2 tablets once a day, every day leading up to surgery.
Drug: Erlotinib

Standard Dose: 1 tablet of 150 mg erlotinib once a day, every day leading up to surgery.

Higher Dose: 200 mg or 300 mg in 2 tablets once a day, every day leading up to surgery.

Depending on your assigned dose level, the 2 tablets may contain the same drug amount or 2 different drug amounts.

Other Names:
  • Erlotinib Hydrochloride
  • OSI-774
  • Tarceva

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  1. Patients with histologically confirmed cancer of the head and neck. Patients with salivary gland tumors and squamous cell carcinomas of the skin are also eligible. (Note: Any patient with a diagnosis of aggressive squamous cell carcinoma of the skin and determined to be surgically resectable will be considered for eligibility. These patients are typically seen in the Head & Neck surgery clinic and decisions for study consideration will be based on consultations with the department of Head & Neck surgery.)
  2. The patient must have biopsy-accessible disease.
  3. Patients must be surgical candidates (either definitive or palliative setting).
  4. Patients may have received prior therapy including cytotoxic chemotherapy (e.g. platinum drugs and taxanes) and radiation therapy.
  5. Patients must have a performance score (ECOG) of 0-2.
  6. Patients should have adequate bone marrow function, as defined by peripheral granulocyte count of >/= 1,000/mm³, and a platelet count of >/= 50,000/mm³.Patients must have adequate liver function with a bilirubin </= 1.5 times the upper limit of normal (ULN). Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be </= 2 x the ULN and alkaline phosphatase must be </= 2 x ULN.
  7. Patients should have adequate renal function (serum creatinine </= 1.5 x ULN).
  8. Age >/= 18 years
  9. Ability to understand and the willingness to sign a written informed consent document indicating that they are aware of the investigational nature of the study, in keeping with institutional policy
  10. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Childbearing potential will be defined as women who have had menses within the past 12 months,who have not had tubal ligation or bilateral oophorectomy. Should a woman become pregnant or suspect that she is pregnant while participating in this study,she should inform her treating physician immediately.The patient,if a man,agrees to use effective contraception or abstinence.

Exclusion Criteria:

  1. Patients with prior exposure to small molecule tyrosine kinase inhibitors or EGFR-targeted antibodies within the past 6 months.
  2. Patients for whom, in the opinion of the treating surgeon, the administration of erlotinib would cause a deleterious delay in surgical treatment.
  3. Patients with uncompensated congestive cardiac failure.
  4. Patients with an organ allograft.
  5. Patients with a serious concurrent infection or illness including, but not limited to, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that could limit compliance with study requirements.
  6. Female patients who are pregnant or breastfeeding
  7. Patients currently on chemotherapy, immunotherapy, or therapy with monoclonal antibodies or other investigational agents with anti-tumor activity
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00954226

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
OSI Pharmaceuticals
Investigators
Study Chair: William N. William Jr., MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00954226     History of Changes
Other Study ID Numbers: 2008-0137
Study First Received: August 6, 2009
Last Updated: June 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Head & Neck squamous cell carcinoma
HN cancer
Surgery
Erlotinib
Biomarkers
Phosphorylation of AKT

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 21, 2014