Metformin Hydrochloride and Doxycycline in Treating Patients With Localized Breast or Uterine Cancer (NCT02874430) | Clinical Trial Compass
TerminatedPhase 2
Metformin Hydrochloride and Doxycycline in Treating Patients With Localized Breast or Uterine Cancer
Stopped: study closed early due to slow accrual
United States29 participantsStarted 2016-06-08
Plain-language summary
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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Diagnosis of localized breast or uterine cancer 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.
✓. Subjects must be newly diagnosed or suspected to have breast, uterine (endometrial cancer with histologies including endometrioid, serous, clear cell, and carcinosarcoma) or cervical cancer.
✓. Patient must be able to swallow pills.
✓. Patients with serum creatinine levels less than 1.5 mg/dL.
✓. Women of child bearing potential must have a negative urine or blood pregnancy test within 14 days of study enrollment.
✓. Informed Consent: All subjects must be able to comprehend and sign a written informed consent document.
✓. ECOG Performance status \<1
Exclusion criteria
What they're measuring
1
Change in the Percentage of Stromal Cells Expressing Caveolin-1 (CAV1) at an Intensity of 1+ or Greater by Immunohistochemistry
Timeframe: Pre-treatment (Baseline) and Post-treatment (week 6)
Trial details
NCT IDNCT02874430
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
✕. Received any prior cancer therapy for the breast or uterine cancer that is being resected, including progesterone therapy for endometrial cancer patients.
✕. Subjects who are pregnant or breastfeeding or may become pregnant during metformin and doxycycline administration.
✕. Subjects on metformin or doxycycline for any reason during the preceding 4 weeks.
✕. Diabetic subjects that are managed by taking metformin or insulin.
✕. Subjects who have received iodinated contrast dye must wait 12 hours prior to starting Metformin. If a CT scan with contrast is scheduled after screening and consent, the metformin cannot be taken until after the CT with contrast has been completed and they have waited 12 hours.
✕. Patients with serum creatinine level greater than 1.5 mg/dL.
✕. Patients with history of lactic or any other metabolic acidosis.
✕. Patients with history of congestive heart failure stage III or greater.