Pre-Surgery Erlotinib for Head and Neck Cancer

Overseen by Xiuning Le, M.D., Ph.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Xiuning Le, M.D., Ph.D.

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

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.

My kidneys are working well.

Exclusion Criteria

I am not pregnant or breastfeeding.

I am currently undergoing chemotherapy, immunotherapy, or treatment with monoclonal antibodies.

I haven't taken any cancer drugs targeting EGFR in the last 6 months.

Treatment Details

Interventions

• Erlotinib Hydrochloride (Tyrosine Kinase Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Arm II (high-dose erlotinib hydrochloride) Experimental Treatment 2 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 Treatment 2 Interventions

Patients receive standard-dose erlotinib hydrochloride PO QD for 2-3 weeks (up to 8 weeks if surgery is delayed).

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School