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Metformin plus chemotherapy for Brenner Tumor

Phase 2
Waitlist Available
Led By Seiko Yamada
Research Sponsored by University of Chicago
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 2 years
Awards & highlights

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.

Eligible Conditions
  • Brenner Tumor
  • Ovarian Carcinoma
  • Ovarian Adenocarcinoma
  • Ovarian Epithelial Carcinoma
  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Ovarian Germ Cell Tumor
  • Peritoneal Cancer
  • Primary Peritoneal Cavity Cancer
  • Malignant Ascites
  • Malignant Pleural Effusion

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression free survival (PFS) evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 and Gynecological Cancer Intergroup (GCIG) criteria
Secondary study objectives
Incidence of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Overall survival
Time to biochemical (CA-125) progression using GCIG criteria

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Metformin plus chemotherapyExperimental Treatment2 Interventions
Patients receive metformin hydrochloride PO BID and standard chemotherapy for 6 -8 cycles. Treatment with metformin hydrochloride continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
Group II: Placebo plus chemotherapyPlacebo Group2 Interventions
Patients receive placebo PO BID and standard chemotherapy for 6 -8 cycles. Treatment with placebo continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
metformin hydrochloride
2010
Completed Phase 3
~5940
Chemotherapy
2003
Completed Phase 4
~3050

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,034 Previous Clinical Trials
753,681 Total Patients Enrolled
Seiko YamadaPrincipal InvestigatorUniversity of Chicago
~5 spots leftby Feb 2025
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