Evaluation of Metformin, Targeting Cancer Stem Cells for Prevention of Relapse in Gynecologic Patients

NCT01579812 | Completed Phase 2 Results DMC

• 2 other identifiers: UMCC 2011.037HUM 47900
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to determine if metformin administered in combination with chemotherapy to women with advanced ovarian, primary peritoneal or fallopian tube cancer will improve recurrence-free survival at 18 months compared to controls.

Conditions

Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

Keywords

Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

Outcome Measures

Primary Outcomes (1)

• Recurrence-Free Survival

  Determine the percentage of patients alive without recurrence at 18 months. Investigators will also determine recurrence free survival when patients with persistent disease are excluded. Definition of progression or recurrence and survival will be defined as increasing clinical, radiological or histological evidence of disease since study entry or two serum values of CA-125 greater than or equal to two times the upper limits of normal (ULN) performed at least one week apart, regardless of CT scan results. Recurrence-Free Interval will be defined as date from start of chemotherapy to the date of first clinical, biochemical, or radiological evidence of progression or death due to any cause.

  18 months

Secondary Outcomes (1)

• Overall Survival

  Up to 3 Years

Study Arms (1)

Metformin

EXPERIMENTAL

Drug: Metformin

Interventions

Metformin DRUG

Patients receiving primary surgical debulking followed by adjuvant chemotherapy will initiate metformin prior to primary surgery. Following surgery patients will be initiated on metformin prior to the initiation of chemotherapy. Patients treated with neoadjuvant chemotherapy will be initiated on metformin prior to the initiation of chemotherapy. Following surgery patients will be initiated on metformin prior to the re-initiation of chemotherapy.

Also known as: Fortamet, Glucophage, Glumetza, Riomet

Metformin

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with potential diagnosis of ovarian, fallopian, or primary peritoneal cancer.
• Care plan including surgical debulking and traditional adjuvant or neo-adjuvant chemotherapy (6-9 cycles of platinum and taxane based therapy).
• Eastern Cooperative Oncology Group performance status 0-2.
• Age \> 18 years or \< 80 years.
• Adequate renal function (serum creatinine \<1.4mg/dL).
• Adequate liver function (bilirubin \< 1.5 times ULN).
• Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) \< 5 times the upper limit of normal in case of liver metastases.
• ALT or AST \< 2.5 times the ULN in absence of liver metastases.
• Ability to understand and complete written informed consent.
• Mentally, physically, and geographically able to undergo treatment and follow up.

You may not qualify if:

• Patients diabetes mellitus. (Patients with only a history of gestational diabetes will be allowed to be included in the study.)
• Metformin use in the last 6 months.
• A known hypersensitivity to metformin.
• A history of metabolic acidosis, including ketoacidosis or increased risk of lactic acidosis.
• Pregnancy or Lactation.
• Patients who have any severe and/or uncontrolled medical conditions.
• Patients with a history of renal disease.
• Patients with other known active malignancy (excluding adequately treated basal cell / squamous cell skin cancer, in situ cancer, or other cancer for which the patient has been disease free for 2 years).
• Patients receiving any other investigational agents.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Brown JR, Chan DK, Shank JJ, Griffith KA, Fan H, Szulawski R, Yang K, Reynolds RK, Johnston C, McLean K, Uppal S, Liu JR, Cabrera L, Taylor SE, Orr BC, Modugno F, Mehta P, Bregenzer M, Mehta G, Shen H, Coffman LG, Buckanovich RJ. Phase II clinical trial of metformin as a cancer stem cell-targeting agent in ovarian cancer. JCI Insight. 2020 Jun 4;5(11):e133247. doi: 10.1172/jci.insight.133247.

  PMID: 32369446 DERIVED

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Dr. Ronald Buckanovich, MD, PhD
• Organization: UPMC Hillman Cancer Center

buckanovichrj@mwri.magee.edu

412-641-4721

Study Officials

• Ronald J. Buckanovich, MD, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2012
• First Posted: April 18, 2012
• Study Start: October 1, 2011
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: May 25, 2018
• Results First Posted: May 25, 2018

Record last verified: 2018-05

Locations

US (1)