Imatinib + Cetuximab for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

Overseen byJustine Bruce, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: University of Wisconsin, Madison

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?This trial tests a combination of two drugs, imatinib and cetuximab, in patients with head and neck cancer who are about to undergo surgery or radiation. Researchers want to see if a specific protein in the tumor cells affects how well the treatment works. Participants will be involved in the study for over a year. Imatinib has been used for several years in the treatment of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST).

Eligibility Criteria

Adults over 18 with squamous cell carcinoma of the head and neck, who are candidates for curative surgery or chemoradiation. They must have a tumor large enough for biopsy samples and adequate organ function. Excluded are those with certain other cancers, recent major treatments, ongoing investigational drug use, allergies to study drugs, or severe medical conditions.

Inclusion Criteria

I am a candidate for treatment aimed at curing my cancer through surgery, radiation, or both.

My tumor is large enough for multiple biopsy samples after treatment.

My oropharyngeal cancer is HPV-negative.

+5 more

Exclusion Criteria

I haven't had chemotherapy or radiotherapy in the last 4 to 6 weeks.

Subjects who are receiving any other investigational agents

I do not have any severe illnesses that are not under control.

+3 more

Participant Groups

This trial tests if protein AXL levels in tumors predict response to cetuximab combined with imatinib in head and neck cancer patients. Participants will be studied from diagnosis until up to 16 months after treatment involving surgery or chemoradiation.

1Treatment groups

Experimental Treatment

Group I: Imatinib Cetuximab CombinationExperimental Treatment2 Interventions

Participants will receive two doses of CTX and a minimum of an 8 day (maximum 14 day) course of imatinib prior to definitive surgery or definitive radiation/chemoradiation.

Cetuximab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Erbitux for:

Locally or regionally advanced squamous cell carcinoma of the head and neck
Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck
K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer
BRAF V600E mutation-positive metastatic colorectal cancer

🇪🇺 Approved in European Union as Erbitux for: