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

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.

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

Interventions

DRUG

metformin hydrochloride

Given PO

DRUG

placebo

Given PO

DRUG

Chemotherapy

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.

Sponsors & Collaborators

• University of Chicago

  lead OTHER

Principal Investigators

• Seiko Yamada · University of Chicago

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-02-25

Primary Completion

2022-10-27

Completion

2024-10-08

Countries

• United States

Study Locations