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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of erlotinib hydrochloride in stopping tumor growth in people with head and neck cancer. Participants will receive either a standard or high dose of the drug before surgery. The goal is to determine if blocking certain enzymes can control cancer cell growth. This trial is suitable for individuals with confirmed head and neck cancer, including salivary gland tumors or skin squamous cell carcinomas, who are eligible for surgery. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking cancer research.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot be on chemotherapy, immunotherapy, or certain other cancer treatments while participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that erlotinib hydrochloride generally has a safe profile. In various studies, it was found to be tolerable for patients with advanced skin cancer when used with radiation therapy. Common side effects include rash and diarrhea, but these are usually manageable.

Erlotinib is already approved for treating other types of cancer, indicating its safety has been well-studied in those cases. However, side effects can vary based on the dose and the individual. In this trial, participants will receive either a standard or high dose of erlotinib before surgery to assess how well patients tolerate these doses.

Overall, while erlotinib is generally well-tolerated, discussing potential risks with a healthcare provider is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for head and neck cancer, which typically involve surgery, radiation, and chemotherapy, erlotinib hydrochloride is a targeted therapy that specifically inhibits the epidermal growth factor receptor (EGFR). Researchers are excited because this targeted approach can potentially interrupt the signals that promote cancer cell growth, offering a more precise attack on cancer cells with potentially fewer side effects. Moreover, the trial explores both high-dose and standard-dose regimens, which could help determine if higher doses can enhance effectiveness or if the standard dose is sufficient, especially for patients who smoke or have delayed surgeries. This tailored approach could lead to more personalized and effective treatment options for patients.

What evidence suggests that erlotinib hydrochloride might be an effective treatment for head and neck cancer?

Research has shown that erlotinib hydrochloride can help treat head and neck cancer by blocking the enzymes necessary for cancer cell growth. In this trial, participants will receive either a standard dose or a high dose of erlotinib hydrochloride before surgery. One study found that taking erlotinib briefly before surgery might benefit patients with squamous cell carcinoma, a type of head and neck cancer. Erlotinib has also been tested with other treatments like radiation and was found to be safe. This suggests it could be a promising treatment option for head and neck cancer. ^{2 6 7 8 9}

Who Is on the Research Team?

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

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01515137

Study of TARCEVA (Erlotinib) as Adjuvant Treatment for ... Basically, 39 patients will provide the ability to detect a one log difference between any 2 of the 3 groups in pre-post change. Detailed Description. Head and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT00601913

Erlotinib and Surgery in Treating Patients With Head and ... It may also help doctors predict how patients will respond to treatment with erlotinib. PURPOSE: This clinical trial is studying how well erlotinib works when ...

3. ascopubs.org ascopubs.org/doi/10.1200/jco.2011.29.15_suppl.5520

Randomized trial of a short course of erlotinib 150 to 300 ... Randomized trial of a short course of erlotinib 150 to 300 mg daily prior to surgery for squamous cell carcinomas of the head and neck (SCCHN) ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3607201/

Phase I Study of Erlotinib Plus Radiation Therapy ... Erlotinib and radiation therapy had an acceptable toxicity profile in patients with advanced cutaneous squamous cell carcinoma.

5. patlynk.com patlynk.com/trial/NCT00412217

A Study of Erlotinib (Tarceva) in Participants With Resected ... This two-arm study will compare the efficacy and safety of erlotinib (Tarceva) versus placebo in participants with resected head and neck squamous cell ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT00412217

A Study of Erlotinib (Tarceva) in Participants With Resected ... This two-arm study will compare the efficacy and safety of erlotinib (Tarceva) versus placebo in participants with resected head and neck ...

7. mayoclinic.org mayoclinic.org/drugs-supplements/erlotinib-oral-route/description/drg-20067325

Erlotinib (oral route) - Side effects & dosage It works by interfering with the growth of cancer cells, which are eventually destroyed. This medicine is available only with your doctor's ...

8. oncologynewscentral.com oncologynewscentral.com/drugs/monograph/92157-304028/erlotinib-oral

Erlotinib hydrochloride: uses, dosing, warnings, adverse ... The manufacturer states that the safety and efficacy of erlotinib have not been established in patients with NSCLC whose tumors harbor EGFR mutations other than ...

9. openaccessjournals.com openaccessjournals.com/articles/erlotinib-tarceva-inhibits-oral-cavity-carcinoma-and-synergizes-with-cisplatin-and-ionizing-radiation-in-vitro.pdf

Erlotinib (Tarceva®) inhibits oral cavity carcinoma and ... Tarceva can potentiate the effect of cisplatin in cell killing. • Human head and neck squamous cell carcinoma frequently expresses. EGFR by immunohistochemistry ...