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NCT02122185 · ClinicalTrials.gov registry record · Phase 2
Metformin and Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
A Phase 2 study of Ovarian Endometrioid Adenocarcinoma and Recurrent Ovarian Epithelial Cancer, sponsored by University of Chicago.
- Active
- Registry status
- Phase 2
- Development phase
- 110
- Enrollment target
- 10
- Study locations
NCT02122185: Active Phase 2 study of Ovarian Endometrioid Adenocarcinoma and Recurrent Ovarian Epithelial Cancer, sponsored by University of Chicago.
NCT02122185 is a Phase 2 study of Ovarian Endometrioid Adenocarcinoma and Recurrent Ovarian Epithelial Cancer that is active but no longer recruiting, run by University of Chicago. The registered enrollment target is 110 participants, below the 295-participant average among 15 other Ovarian Endometrioid Adenocarcinoma trials with a reported enrollment target (63% lower). The trial reports 10 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02122185, a Phase 2 study of Ovarian Endometrioid Adenocarcinoma and Recurrent Ovarian Epithelial Cancer, is active but no longer recruiting, sponsored by University of Chicago.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 110 participants
- Enrollment target
- 10
- Study locations
Study Summary
This randomized phase II trial studies how well metformin hydrochloride and combination chemotherapy works in treating patients with stage III-IV ovarian, fallopian tube, or primary peritoneal cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Metformin hydrochloride may help carboplatin, paclitaxel and docetaxel work better by making tumor cells more sensitive to the drugs. Studying samples of blood and tissue in the laboratory from patients receiving metformin hydrochloride may help doctors learn more about the effects of metformin hydrochloride on cells. It may also help doctors understand how well patients respond to treatment. Giving metformin hydrochloride together with combination chemotherapy may kill more tumor cells.
Primary Outcome
Time to disease progression or death from any cause. Progression evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 and Gynecological Cancer Intergroup (GCIG) criteria. For example, progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Conditions Studied
Interventions
- DRUG placebo
- DRUG Chemotherapy
- DRUG metformin hydrochloride
Study Locations (10)
Illinois
- NCH Medical Group- Northwest Community Hospital - Arlington Heights
- Rush University Medical Center - Chicago
- University of Chicago - Chicago
- Decatur Memorial Hospital - Decatur
- NorthShore University HealthSystem - Evanston
- Ingalls Memorial Hospital - Harvey
Alabama
- University of Alabama - Birmingham
- Mitchell Cancer Institute - University of South Alabama - Mobile
California
- City of Hope - Duarte
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2015-02-25 |
| Est. Completion | 2027-02-25 |
| Phase | Phase 2 |
What the registry record for NCT02122185 still lists
NCT02122185 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 295-participant average among 15 other Ovarian Endometrioid Adenocarcinoma trials with a reported enrollment target (63% lower).
The record links to 10 conditions, with Ovarian Endometrioid Adenocarcinoma appearing as the primary indexed condition, and to 3 interventions - of which placebo is the first listed.
NCT02122185 lists 10 locations in 4 states (Illinois, Alabama, California).
Frequently Asked Questions
What is clinical trial NCT02122185 about?
NCT02122185 is a clinical study titled "Metformin and Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer". This randomized phase II trial studies how well metformin hydrochloride and combination chemotherapy works in treating patients with stage III-IV ovarian, fallopian tube, or primary peritoneal cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel and docetaxel, work in different ways t...
What is the current status of trial NCT02122185?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2015-02-25. Estimated completion is 2027-02-25.
What conditions does trial NCT02122185 study?
This clinical trial studies the following conditions: Ovarian Endometrioid Adenocarcinoma, Recurrent Ovarian Epithelial Cancer, Recurrent Fallopian Tube Cancer, Malignant Pleural Effusion, Ovarian Clear Cell Cystadenocarcinoma.
What interventions are being tested in trial NCT02122185?
The interventions under investigation include: placebo (DRUG), Chemotherapy (DRUG), metformin hydrochloride (DRUG).
Who is sponsoring clinical trial NCT02122185?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02122185 being conducted?
This trial has 10 study locations across Alabama, California, Illinois, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ovarian Endometrioid Adenocarcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02122185's enrollment target sits among peer trials
110 7th of 15 higher than 9 of 15 other Ovarian Endometrioid Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian Endometrioid Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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