Your session is about to expire
← Back to Search
Tyrosine Kinase Inhibitor
Pre-Surgery Erlotinib for Head and Neck Cancer
Phase 1
Waitlist Available
Led By Xiuning Le
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with histologically confirmed cancer of the head and neck, including salivary gland tumors and squamous cell carcinomas of the skin
Patients must be surgical candidates (either definitive or palliative setting)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to surgery
Awards & highlights
Study Summary
This trial tests different doses of a drug to treat head and neck cancer before surgery. The drug may stop tumor growth by blocking enzymes.
Who is the study for?
This trial is for adults with head and neck cancer, including salivary gland tumors and aggressive skin squamous cell carcinoma. Candidates must be able to undergo surgery, have a performance score of 0-2, adequate organ function, and agree to use contraception. It's not for those needing immediate surgery or with serious health issues like heart disease.Check my eligibility
What is being tested?
The study tests how standard-dose or high-dose erlotinib hydrochloride affects tumor cells when given before surgery in patients with head and neck cancer. The drug aims to block enzymes that promote cell growth.See study design
What are the potential side effects?
Erlotinib may cause side effects such as rash, diarrhea, loss of appetite, fatigue, difficulty breathing due to lung problems, liver issues (abnormal liver blood tests), eye irritation or pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a confirmed diagnosis of head, neck, or salivary gland cancer.
Select...
I am eligible for surgery, whether to try to cure my condition or to relieve symptoms.
Select...
I am able to get out of my bed or chair and move around.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in modulation of the biomarker phospho-Akt in tumor specimens
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (high-dose erlotinib hydrochloride)Experimental Treatment2 Interventions
Patients 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).
Group II: Arm I (standard-dose erlotinib hydrochloride)Experimental Treatment2 Interventions
Patients receive standard-dose erlotinib hydrochloride PO QD for 2-3 weeks (up to 8 weeks if surgery is delayed).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Erlotinib Hydrochloride
2010
Completed Phase 2
~2820
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,401 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,598 Total Patients Enrolled
Xiuning LePrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
158 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or breastfeeding.I am currently undergoing chemotherapy, immunotherapy, or treatment with monoclonal antibodies.I have a confirmed diagnosis of head, neck, or salivary gland cancer.I am eligible for surgery, whether to try to cure my condition or to relieve symptoms.I haven't taken any cancer drugs targeting EGFR in the last 6 months.Taking erlotinib would dangerously delay my needed surgery.I have heart failure that is not well-managed.I have received an organ transplant from another person.My kidneys are working well.I have had chemotherapy or radiation therapy before.I am able to get out of my bed or chair and move around.I am 18 years old or older.I do not have a serious infection or illness right now.My bone marrow and liver are working well.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (standard-dose erlotinib hydrochloride)
- Group 2: Arm II (high-dose erlotinib hydrochloride)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Share this study with friends
Copy Link
Messenger