Pre-Surgery Erlotinib for Head and Neck Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Tyrosine kinase inhibitors, EGFR antibodies

Disqualifiers: Congestive cardiac failure, Organ allograft, others

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

Compensation: Varies

Number of Visits: 30

Duration: 2-8 weeks

48 Participants Needed

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.

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

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+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+