Metformin Hydrochloride and Doxycycline in Treating Patients With Head and Neck Squamous Cell Carcinoma

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Study ID
NCT03076281
Phase
PHASE2
Status
Terminated

Conditions

  • LIP
  • Larynx
  • Oral Cavity
  • Pharynx

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Metformin Hydrochloride — DRUG
    Given orally
  • Doxycycline — DRUG
    Given orally
  • Metformin +Doxycycline — DRUG
    Given orally

Study Details

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.

Key Dates

Start date
Apr 3, 2017
Status verified
Jan 2026
Primary completion
Dec 3, 2018
Completion
Dec 3, 2018

Study Design

Enrollment
7 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (metformin hydrochloride)
    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
  • Experimental: Arm B (doxycycline)
    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.
  • Experimental: Arm C (metformin hydrochloride, doxycycline)
    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.

Primary Outcome Measure

Change in Percentage of CFS Expressing Caveolin-1 at an Intensity of 1+ or Greater Assessed in Tumor-associated Stroma Cells by Immunohistochemistry [ Time Frame: Baseline to 30 days after last drug dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-

Related coverage on Hipa.ai

Find similar trials in Philadelphia, PA

By research site
Sidney Kimmel Cancer Center at Thomas Jefferson University· Philadelphia, PA

Related Studies