Phase Ib Study of Erlotinib Prior to Surgery in Patients With Head and Neck Cancer
3 other identifiers
interventional
48
1 country
1
Brief Summary
This randomized phase Ib trial studies standard-dose or high-dose erlotinib hydrochloride before surgery in treating patients with head and neck cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2009
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 5, 2009
CompletedFirst Submitted
Initial submission to the registry
August 6, 2009
CompletedFirst Posted
Study publicly available on registry
August 7, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2025
CompletedSeptember 5, 2025
August 1, 2025
15.7 years
August 6, 2009
August 28, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change in modulation of the biomarker phospho-Akt in tumor specimens
Modulation of phospho-Akt (difference in immunohistochemistry \[IHC\] score between the surgical specimen and the baseline biopsy) will be compared between the two treatment arms (i.e., standard-dose and high-dose) with the use of Wilcoxon rank sum test.
From baseline to surgery
Study Arms (2)
Arm I (standard-dose erlotinib hydrochloride)
EXPERIMENTALPatients receive standard-dose erlotinib hydrochloride PO QD for 2-3 weeks (up to 8 weeks if surgery is delayed).
Arm II (high-dose erlotinib hydrochloride)
EXPERIMENTALPatients receive high-dose erlotinib hydrochloride PO QD for 2-3 weeks (2-8 weeks for current smokers or up to 8 weeks if surgery is delayed).
Interventions
Given PO
Correlative studies
Eligibility Criteria
You may qualify if:
- 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.)
- The patient must have biopsy-accessible disease.
- Patients must be surgical candidates (either definitive or palliative setting).
- Patients may have received prior therapy including cytotoxic chemotherapy (e.g. platinum drugs and taxanes) and radiation therapy.
- Patients must have a performance score (ECOG) of 0-2.
- 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.
- Patients should have adequate renal function (serum creatinine \</= 1.5 x ULN).
- Age \>/= 18 years
- 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
- 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.
You may not qualify if:
- Patients with prior exposure to small molecule tyrosine kinase inhibitors or EGFR-targeted antibodies within the past 6 months.
- Patients for whom, in the opinion of the treating surgeon, the administration of erlotinib would cause a deleterious delay in surgical treatment.
- Patients with uncompensated congestive cardiac failure.
- Patients with an organ allograft.
- 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.
- Female patients who are pregnant or breastfeeding
- Patients currently on chemotherapy, immunotherapy, or therapy with monoclonal antibodies or other investigational agents with anti-tumor activity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiuning Le
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2009
First Posted
August 7, 2009
Study Start
August 5, 2009
Primary Completion
April 30, 2025
Study Completion
April 30, 2025
Last Updated
September 5, 2025
Record last verified: 2025-08