Metformin and Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Chicago
Study ID
NCT02122185
Phase
PHASE2
Status
Completed

Conditions

  • Brenner Tumor
  • Malignant Ascites
  • Malignant Pleural Effusion
  • Ovarian Clear Cell Cystadenocarcinoma
  • Ovarian Endometrioid Adenocarcinoma
  • Ovarian Mixed Epithelial Carcinoma
  • Ovarian Serous Cystadenocarcinoma
  • Ovarian Undifferentiated Adenocarcinoma
  • Recurrent Fallopian Tube Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Recurrent Ovarian Germ Cell Tumor
  • Recurrent Primary Peritoneal Cavity Cancer
  • Stage IIIA Fallopian Tube Cancer
  • Stage IIIA Ovarian Epithelial Cancer
  • Stage IIIA Ovarian Germ Cell Tumor
  • Stage IIIA Primary Peritoneal Cavity Cancer
  • Stage IIIB Fallopian Tube Cancer
  • Stage IIIB Ovarian Epithelial Cancer
  • Stage IIIB Ovarian Germ Cell Tumor
  • Stage IIIB Primary Peritoneal Cavity Cancer
  • Stage IIIC Fallopian Tube Cancer
  • Stage IIIC Ovarian Epithelial Cancer
  • Stage IIIC Ovarian Germ Cell Tumor
  • Stage IIIC Primary Peritoneal Cavity Cancer
  • Stage IV Fallopian Tube Cancer
  • Stage IV Ovarian Epithelial Cancer
  • Stage IV Ovarian Germ Cell Tumor
  • Stage IV Primary Peritoneal Cavity Cancer

Eligibility Criteria

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

Interventions

  • metformin hydrochloride — DRUG
    Given PO
  • placebo — DRUG
    Given PO
  • Chemotherapy — DRUG
    Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.

Study Details

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.

Key Dates

Start date
Feb 25, 2015
Status verified
Mar 2026
Primary completion
Oct 27, 2022
Completion
Oct 8, 2024

Study Design

Enrollment
111 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Metformin plus chemotherapy
    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.
  • Placebo Comparator: Placebo plus chemotherapy
    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.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Up to 6 years ]

Locations (10)

FacilityCityStateZIPSite coordinators
University of AlabamaBirminghamAlabama35233-
Mitchell Cancer Institute - University of South AlabamaMobileAlabama36604-
City of HopeDuarteCalifornia91010-
NCH Medical Group- Northwest Community HospitalArlington HeightsIllinois60005-
Rush University Medical CenterChicagoIllinois60612-
University of ChicagoChicagoIllinois60637-
Decatur Memorial HospitalDecaturIllinois62526-
NorthShore University HealthSystemEvanstonIllinois60201-
Ingalls Memorial HospitalHarveyIllinois60426-
Mayo ClinicRochesterMinnesota55905-

Related coverage on Hipa.ai

Find similar trials in Birmingham, AL

By research site
University of Alabama· Birmingham, ALMitchell Cancer Institute - University of South Alabama· Mobile, ALCity of Hope· Duarte, CANCH Medical Group- Northwest Community Hospital· Arlington Heights, ILRush University Medical Center· Chicago, ILUniversity of Chicago· Chicago, IL

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