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Anti-diabetic
Metformin Hydrochloride for Endometrial Adenocarcinoma
Phase 2
Waitlist Available
Led By Jennifer Johnson, MD, PhD
Research Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months post last dose of metformin and doxycycline
Awards & highlights
Study Summary
This trialstudies if metformin+doxycycline can help treat localized breast/uterine cancer & reduce toxic side effects of anti-cancer therapy.
Eligible Conditions
- Endometrial Adenocarcinoma
- Breast Cancer
- Endometrial Cancer
- Endometrial Carcinoma
- Uterine Carcinosarcoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months post last dose of metformin and doxycycline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months post last dose of metformin and doxycycline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in the percent of stromal cells expressing Caveolin-1 (CAV1) at an intensity of 1+ or greater assessed by immunohistochemistry
Secondary outcome measures
Change in the percent of stromal cells expressing express Monocarboxylate Transporter 4 (MCT4) in the cancer cells
Change in the percent of tumor cells that express Monocarboxylate Transporter 1 (MCT1) and Transporter of Outer Mitochondrial Membrane 20 (TOMM20) in the cancer cells
Incidence of adverse events evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (metformin hydrochloride, doxycycline)Experimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxycycline
2008
Completed Phase 4
~2430
Metformin Hydrochloride
2016
Completed Phase 4
~1430
Find a Location
Who is running the clinical trial?
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor
162 Previous Clinical Trials
10,884 Total Patients Enrolled
Jennifer Johnson, MD, PhDPrincipal InvestigatorThomas Jefferson University
5 Previous Clinical Trials
100,106 Total Patients Enrolled
Frequently Asked Questions
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