48 Participants Needed

Pre-Surgery Erlotinib for Head and Neck Cancer

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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 | MD Anderson Cancer Center

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.
See 6 more

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.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard-dose or high-dose erlotinib hydrochloride orally once daily for 2-3 weeks, up to 8 weeks if surgery is delayed

2-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
Follow-up within 30 days after treatment

Treatment Details

Interventions

  • Erlotinib Hydrochloride
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
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).

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+
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