Metformin Hydrochloride and Doxycycline in Treating Patients With Head and Neck Squamous Cell Carcinoma That Can Be Removed by Surgery

Recruiting in Palo Alto (17 mi)

Overseen byJennifer Johnson, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This randomized phase II trial studies how well metformin hydrochloride and doxycycline work in treating patients with head and neck squamous cell carcinoma that can be removed by surgery. Metformin hydrochloride may reduce the metabolic activity of cancer cells and of surrounding supportive tissue. Doxycycline may minimize toxic side effects of anti-cancer therapy. Giving metformin hydrochloride and doxycycline may work better in treating patients with head and neck squamous cell carcinoma.

Eligibility Criteria

Inclusion Criteria

Diagnosis of head and neck squamous cell carcinoma that is either biopsy proven or suspected based on history, physical, and or radiographic findings, and who are planned for definitive resection of the tumor without the use of neoadjuvant chemotherapy or radiation therapy at TJUH are eligible to participate.

Subjects must be ≥ 18 years of age at time of consent.

Patient must be able to swallow pills.

+4 more

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Arm C (metformin hydrochloride, doxycycline)Experimental Treatment1 Intervention

Patients receive metformin hydrochloride PO daily on days 1-3 and twice daily starting on day 4 to the day prior to surgery and doxycycline PO every 12 hours on days 1to the day prior to surgery in the absence of disease progression or unacceptable toxicity.

Group II: Arm B (doxycycline)Experimental Treatment1 Intervention

Patients receive doxycycline PO every 12 hours on days 1 to the day prior to surgery in the absence of disease progression or unacceptable toxicity.

Group III: Arm A (metformin hydrochloride)Experimental Treatment1 Intervention

Patients receive metformin hydrochloride PO daily on days 1-3 and twice daily starting on day 4 to the day prior to surgery in the absence of disease progression or unacceptable toxicity

Doxycycline is already approved in United States, European Union, Canada, Japan, Australia for the following indications:

🇺🇸 Approved in United States as Doxycycline for: