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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)
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to surgery
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I have a confirmed diagnosis of head, neck, or salivary gland cancer.
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I am eligible for surgery, whether to try to cure my condition or to relieve symptoms.
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I am able to get out of my bed or chair and move around.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant or breastfeeding.
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I am currently undergoing chemotherapy, immunotherapy, or treatment with monoclonal antibodies.
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I have heart failure that is not well-managed.
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I have received an organ transplant from another person.
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I do not have a serious infection or illness right now.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in modulation of the biomarker phospho-Akt in tumor specimens

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~2900

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,066 Previous Clinical Trials
1,802,197 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,953 Total Patients Enrolled
Xiuning LePrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
158 Total Patients Enrolled

Media Library

Erlotinib Hydrochloride (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00954226 — Phase 1
Squamous Cell Carcinoma Research Study Groups: Arm II (high-dose erlotinib hydrochloride), Arm I (standard-dose erlotinib hydrochloride)
Squamous Cell Carcinoma Clinical Trial 2023: Erlotinib Hydrochloride Highlights & Side Effects. Trial Name: NCT00954226 — Phase 1
Erlotinib Hydrochloride (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00954226 — Phase 1
~1 spots leftby Mar 2025
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