Metformin Hydrochloride and Doxycycline in Treating Patients With Localized Breast or Uterine Cancer

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Study ID
NCT02874430
Phase
PHASE2
Status
Terminated

Conditions

  • Breast Carcinoma
  • Endometrial Clear Cell Adenocarcinoma
  • Endometrial Serous Adenocarcinoma
  • Uterine Corpus Cancer
  • Uterine Corpus Carcinosarcoma

Eligibility Criteria

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

Interventions

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

Study Details

This phase II trial studies how well metformin hydrochloride works together with doxycycline in treating patients with localized breast or uterine cancer. Metformin hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Doxycycline may stop the growth of bacteria by keeping them from making proteins and minimized the toxic side effects of anti-cancer therapy. It is not yet known whether giving metformin hydrochloride together with doxycycline may be a better way in treating patients with localized breast or uterine cancer.

Key Dates

Start date
Jun 8, 2016
Status verified
Mar 2026
Primary completion
Dec 11, 2020
Completion
Dec 11, 2020

Study Design

Enrollment
29 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (metformin hydrochloride, doxycycline)
    Patients receive metformin hydrochloride orally daily on days 1-3 and twice a day starting on day 4. Patients also receive doxycycline orally every 12 hours starting on day 1. Treatment repeats every 7 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Change in the Percentage of Stromal Cells Expressing Caveolin-1 (CAV1) at an Intensity of 1+ or Greater by Immunohistochemistry [ Time Frame: Pre-treatment (Baseline) and Post-treatment (week 6) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-

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