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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02065687
Other study ID # GOG-0286B
Secondary ID NCI-2013-02284s1
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date March 17, 2014
Est. completion date September 13, 2023

Study information

Verified date September 2021
Source GOG Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized phase II/III trial studies how well paclitaxel, carboplatin, and metformin hydrochloride works and compares it to paclitaxel, carboplatin, and placebo in treating patients with endometrial cancer that is stage III, IV, or has come back. Drugs used in chemotherapy, such as paclitaxel and carboplatin, 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 paclitaxel and carboplatin work better by making cancer cells more sensitive to the drugs. It is not yet known whether paclitaxel and carboplatin is more effective with or without metformin hydrochloride in treating endometrial cancer.


Description:

PRIMARY OBJECTIVES: I. To determine if the addition of metformin (metformin hydrochloride) to the standard regimen of carboplatin and paclitaxel prolongs progression-free survival (PFS) in women with advanced or recurrent endometrial cancer. (Phase II) II. To determine if the addition of metformin to the standard regimen of carboplatin and paclitaxel prolongs overall survival (OS) in the same population if a phase III study is conducted. Both clinical trials (Phase II and III) will utilize OS as a primary endpoint if a phase III trial is opened. SECONDARY OBJECTIVES: I. To estimate the proportion of patients with objective response (response rate [RR]) in the population of patients with measurable disease by treatment. II. To estimate the duration of response in the population of patients with measurable disease who respond by treatment. III. To estimate overall survival (OS) and relative hazards of death for each treatment arm if the study stops after the phase II trial is completed. If the study continues with a phase III clinical trial, then PFS will be a secondary endpoint. IV. To determine the nature, frequency and degree of toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) for each treatment arm. V. To estimate possible differences in RR, PFS, OS, and toxicity rates for the treatment regimens by the patients' level of obesity. TERTIARY OBJECTIVES: I. To test whether PIK3CA mutations/amplifications, PTEN mutations or PIK3R1/PIK3R2 mutations have a lower hazard of progression or death (PFS endpoint) among patients who are treated with metformin. II. To test whether higher expression of MATE 2 is associated with a lower hazard of progression or death (PFS endpoint) among patients who are treated with metformin. III. To explore the association of metabolic factors (i.e. body mass index [BMI], hip-to-waist ratio, diabetes status, hemoglobin A1c [HgbA1C], fasting insulin and glucose levels, homeostatic model assessment [HOMA] scores) with treatment response to metformin/paclitaxel/carboplatin, PFS, and OS. IV. To test whether genomic profiles (i.e. PIK3CA mutations/amplifications, PTEN mutations or PIK3R1/PIK3R2 mutations) differ between the tumors of obese and non-obese endometrial cancer (EC) patients. V. To correlate expression of key targets of the insulin/IGF-1/mTOR signaling pathway (p-IGF1R, p-S6 and p-4EBP-1) with treatment response to metformin/paclitaxel/carboplatin, PFS, OS and obesity status. VI. To determine if the genetic variants of the metformin transporters correspond with treatment response to metformin/paclitaxel/carboplatin, PFS and OS. VII. To estimate differences in physical functioning, physical activity, and fatigue between treatment arms. VIII. To explore the association between metabolic factors (i.e., BMI, hip-to-waist ratio, diabetes status, HgbA1C, fasting insulin and glucose levels, HOMA scores) and physical functioning, physical activity, and fatigue. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours on day 1, carboplatin IV over 30 minutes on day 1, and metformin hydrochloride orally (PO) twice daily (BID) (approximately 10-12 hours apart) on days 1-21 (once daily [QD] in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising metformin hydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive paclitaxel IV and carboplatin IV as in Arm I. Patients also receive placebo PO BID (approximately 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising placebo PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. In both arms, patients who achieve stable disease (SD) or partial response (PR) and still have measurable disease at the completion of course 6 may continue to receive paclitaxel IV and carboplatin IV (with metformin hydrochloride or placebo) for an additional 4 courses at the discretion of the treating investigator. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 469
Est. completion date September 13, 2023
Est. primary completion date April 17, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients must have measurable stage III, measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial carcinoma - Histologic confirmation of the original primary tumor is required; patients with the following histologic epithelial cell types are eligible: - Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.) - Measurable disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1); measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI - Patients must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2 - Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl - Platelets greater than or equal to 100,000/mcl - Creatinine less than 1.4 mg/dl - Bilirubin less than or equal to 1.5 x institutional/laboratory upper limit of normal (ULN) - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3 x ULN - Alkaline phosphatase less than or equal to 2.5 x ULN - Patients must NOT have received prior chemotherapy or targeted therapy, including chemotherapy used for radiation sensitization for treatment of endometrial carcinoma - Patients may have received prior radiation therapy for treatment of endometrial carcinoma; prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para-aortic radiation therapy, and/or intravaginal brachytherapy; all radiation therapy must be completed at least 4 weeks prior to the first date of study therapy - Patients may have received prior hormonal therapy for treatment of endometrial carcinoma; all hormonal therapy must be discontinued at least one week prior to the first date of study therapy - Patients must be able to swallow and retain orally-administered medication - Patients must have signed an approved informed consent and authorization permitting release of personal health information; individuals with impaired decision-making capacity are not eligible to participate on the study Exclusion Criteria: - Patients must NOT be taking metformin or have been on metformin in the past 6 months - Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer are excluded if there is any evidence of other malignancy being present within the last three years - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Patients who are pregnant or nursing; if patients are of reproductive age and have not undergone hysterectomy, they must use an effective contraceptive method for the duration of this study - Any condition associated with increased risk of metformin-associated lactic acidosis; (e.g. congestive heart failure defined as New York Heart Association [NYHA] class III or IV functional status, history of acidosis of any type; habitual intake of 3 or more alcoholic beverages per day)

Study Design


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Carcinoma
  • Endometrial Adenocarcinoma
  • Endometrial Clear Cell Adenocarcinoma
  • Endometrial Neoplasms
  • Endometrial Serous Adenocarcinoma
  • Endometrial Undifferentiated Carcinoma
  • Recurrent Uterine Corpus Carcinoma
  • Stage III Uterine Corpus Cancer AJCC v7
  • Stage IIIA Uterine Corpus Cancer AJCC v7
  • Stage IIIB Uterine Corpus Cancer AJCC v7
  • Stage IIIC Uterine Corpus Cancer AJCC v7
  • Stage IV Uterine Corpus Cancer AJCC v7
  • Stage IVA Uterine Corpus Cancer AJCC v7
  • Stage IVB Uterine Corpus Cancer AJCC v7

Intervention

Drug:
Carboplatin
Given IV
Other:
Laboratory Biomarker Analysis
Correlative studies
Drug:
Metformin Hydrochloride
Given PO
Paclitaxel
Given IV
Other:
Placebo Administration
Given PO
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies

Locations

Country Name City State
United States Pali Momi Medical Center 'Aiea Hawaii
United States Queen's Cancer Center - Pearlridge 'Aiea Hawaii
United States The Cancer Center of Hawaii-Pali Momi 'Aiea Hawaii
United States Jefferson Abington Hospital Abington Pennsylvania
United States Summa Health System - Akron Campus Akron Ohio
United States Women's Cancer Care Associates LLC Albany New York
United States Southwest Gynecologic Oncology Associates Inc Albuquerque New Mexico
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States American Fork Hospital / Huntsman Intermountain Cancer Center American Fork Utah
United States Mary Greeley Medical Center Ames Iowa
United States McFarland Clinic PC - Ames Ames Iowa
United States AnMed Health Cancer Center Anderson South Carolina
United States Michigan Cancer Research Consortium NCORP Ann Arbor Michigan
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Northwest Community Hospital Arlington Heights Illinois
United States Emory University Hospital Midtown Atlanta Georgia
United States Emory University Hospital/Winship Cancer Institute Atlanta Georgia
United States Northside Hospital Atlanta Georgia
United States Augusta University Medical Center Augusta Georgia
United States Rush - Copley Medical Center Aurora Illinois
United States University of Colorado Hospital Aurora Colorado
United States Dell Seton Medical Center at The University of Texas Austin Texas
United States Texas Oncology - Central Austin Cancer Center Austin Texas
United States Texas Oncology - South Austin Cancer Center Austin Texas
United States Texas Oncology-Austin Midtown Austin Texas
United States Greater Baltimore Medical Center Baltimore Maryland
United States Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland
United States Sinai Hospital of Baltimore Baltimore Maryland
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States Woman's Hospital Baton Rouge Louisiana
United States Bronson Battle Creek Battle Creek Michigan
United States Texas Oncology Bedford Bedford Texas
United States Sanford Joe Lueken Cancer Center Bemidji Minnesota
United States Southwestern Vermont Medical Center Bennington Vermont
United States Central Vermont Medical Center/National Life Cancer Treatment Berlin Vermont
United States Walter Reed National Military Medical Center Bethesda Maryland
United States Saint Luke's University Hospital-Bethlehem Campus Bethlehem Pennsylvania
United States Billings Clinic Cancer Center Billings Montana
United States University of Alabama at Birmingham Cancer Center Birmingham Alabama
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States McFarland Clinic PC-Boone Boone Iowa
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Brigham and Women's Hospital Boston Massachusetts
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Tufts Medical Center Boston Massachusetts
United States Montefiore Medical Center - Moses Campus Bronx New York
United States Montefiore Medical Center-Einstein Campus Bronx New York
United States Montefiore Medical Center-Weiler Hospital Bronx New York
United States New York-Presbyterian/Brooklyn Methodist Hospital Brooklyn New York
United States State University of New York Downstate Medical Center Brooklyn New York
United States Roswell Park Cancer Institute Buffalo New York
United States Highline Medical Center-Main Campus Burien Washington
United States University of Vermont and State Agricultural College Burlington Vermont
United States University of Vermont Medical Center Burlington Vermont
United States Cooper Hospital University Medical Center Camden New Jersey
United States Illinois CancerCare-Canton Canton Illinois
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Illinois CancerCare-Carthage Carthage Illinois
United States Sandra L Maxwell Cancer Center Cedar City Utah
United States UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina
United States Novant Health Presbyterian Medical Center Charlotte North Carolina
United States University of Virginia Cancer Center Charlottesville Virginia
United States Chattanooga's Program in Women's Oncology Chattanooga Tennessee
United States Northwestern University Chicago Illinois
United States Rush University Medical Center Chicago Illinois
United States University of Chicago Comprehensive Cancer Center Chicago Illinois
United States Marshfield Clinic-Chippewa Center Chippewa Falls Wisconsin
United States Bethesda North Hospital Cincinnati Ohio
United States Good Samaritan Hospital - Cincinnati Cincinnati Ohio
United States University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio
United States Case Western Reserve University Cleveland Ohio
United States Cleveland Clinic Cancer Center/Fairview Hospital Cleveland Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States Southeastern Medical Oncology Center-Clinton Clinton North Carolina
United States Medical Oncology and Hematology Associates-West Des Moines Clive Iowa
United States Mercy Cancer Center-West Lakes Clive Iowa
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States Columbus NCI Community Oncology Research Program Columbus Ohio
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States The Mark H Zangmeister Center Columbus Ohio
United States Memorial Sloan Kettering Commack Commack New York
United States Atrium Health Cabarrus/LCI-Concord Concord North Carolina
United States John Muir Medical Center-Concord Campus Concord California
United States MD Anderson in The Woodlands Conroe Texas
United States Mercy Hospital Coon Rapids Minnesota
United States Michiana Hematology Oncology PC-Crown Point Crown Point Indiana
United States Parkland Memorial Hospital Dallas Texas
United States Texas Health Presbyterian Hospital Dallas Dallas Texas
United States Texas Oncology at Baylor Charles A Sammons Cancer Center Dallas Texas
United States UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas
United States Carle on Vermilion Danville Illinois
United States Geisinger Medical Center Danville Pennsylvania
United States Good Samaritan Hospital - Dayton Dayton Ohio
United States Grandview Hospital Dayton Ohio
United States Miami Valley Hospital Dayton Ohio
United States Miami Valley Hospital North Dayton Ohio
United States Beaumont Hospital - Dearborn Dearborn Michigan
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Dekalb Medical Center Decatur Georgia
United States Smilow Cancer Hospital-Derby Care Center Derby Connecticut
United States Medical Oncology and Hematology Associates-Laurel Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Wayne State University/Karmanos Cancer Institute Detroit Michigan
United States Wentworth-Douglass Hospital Dover New Hampshire
United States Duke University Medical Center Durham North Carolina
United States Marshfield Clinic Cancer Center at Sacred Heart Eau Claire Wisconsin
United States Saint Elizabeth Medical Center South Edgewood Kentucky
United States Fairview Southdale Hospital Edina Minnesota
United States Carle Physician Group-Effingham Effingham Illinois
United States Crossroads Cancer Center Effingham Illinois
United States AMITA Health Alexian Brothers Medical Center Elk Grove Village Illinois
United States Elkhart General Hospital Elkhart Indiana
United States Michiana Hematology Oncology PC-Elkhart Elkhart Indiana
United States Green Bay Oncology - Escanaba Escanaba Michigan
United States Illinois CancerCare-Eureka Eureka Illinois
United States NorthShore University HealthSystem-Evanston Hospital Evanston Illinois
United States Inova Schar Cancer Institute Fairfax Virginia
United States Smilow Cancer Hospital Care Center-Fairfield Fairfield Connecticut
United States Inova Fairfax Hospital Falls Church Virginia
United States Sanford Broadway Medical Center Fargo North Dakota
United States Sanford Clinic North-Fargo Fargo North Dakota
United States Sanford Roger Maris Cancer Center Fargo North Dakota
United States Weisberg Cancer Treatment Center Farmington Hills Michigan
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States Poudre Valley Hospital Fort Collins Colorado
United States McFarland Clinic PC-Trinity Cancer Center Fort Dodge Iowa
United States Saint Elizabeth Fort Thomas Fort Thomas Kentucky
United States Texas Oncology - Fort Worth Cancer Center Fort Worth Texas
United States Northeast Georgia Medical Center-Gainesville Gainesville Georgia
United States University of Florida Health Science Center - Gainesville Gainesville Florida
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Northwestern Medicine Cancer Center Delnor Geneva Illinois
United States Adams Cancer Center Gettysburg Pennsylvania
United States MultiCare Gig Harbor Medical Park Gig Harbor Washington
United States Glens Falls Hospital Glens Falls New York
United States NorthShore University HealthSystem-Glenbrook Hospital Glenview Illinois
United States Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina
United States Wayne Memorial Hospital Goldsboro North Carolina
United States CHI Health Saint Francis Grand Island Nebraska
United States Helen DeVos Children's Hospital at Spectrum Health Grand Rapids Michigan
United States Mercy Health Saint Mary's Grand Rapids Michigan
United States Spectrum Health at Butterworth Campus Grand Rapids Michigan
United States Benefis Healthcare- Sletten Cancer Institute Great Falls Montana
United States Green Bay Oncology at Saint Vincent Hospital Green Bay Wisconsin
United States Green Bay Oncology Limited at Saint Mary's Hospital Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin
United States UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg Pennsylvania
United States Saint Francis Hospital Greenville South Carolina
United States Gibbs Cancer Center-Pelham Greer South Carolina
United States Smilow Cancer Hospital Care Center - Guiford Guilford Connecticut
United States Cherry Tree Cancer Center Hanover Pennsylvania
United States Memorial Sloan Kettering Westchester Harrison New York
United States Hartford Hospital Hartford Connecticut
United States Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut
United States Geisinger Medical Center-Cancer Center Hazleton Hazleton Pennsylvania
United States AdventHealth Hendersonville Hendersonville North Carolina
United States NorthShore University HealthSystem-Highland Park Hospital Highland Park Illinois
United States Sudarshan K Sharma MD Limited-Gynecologic Oncology Hinsdale Illinois
United States Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii
United States Hawaii Cancer Care Inc-Liliha Honolulu Hawaii
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States Kuakini Medical Center Honolulu Hawaii
United States Queen's Cancer Center - Kuakini Honolulu Hawaii
United States Queen's Medical Center Honolulu Hawaii
United States Straub Clinic and Hospital Honolulu Hawaii
United States The Cancer Center of Hawaii-Liliha Honolulu Hawaii
United States University of Hawaii Cancer Center Honolulu Hawaii
United States Houston Methodist Hospital Houston Texas
United States Lyndon Baines Johnson General Hospital Houston Texas
United States M D Anderson Cancer Center Houston Texas
United States MD Anderson West Houston Houston Texas
United States Memorial Hermann Texas Medical Center Houston Texas
United States Methodist Willowbrook Hospital Houston Texas
United States Edwards Comprehensive Cancer Center Huntington West Virginia
United States Tennessee Valley Gynecologic Oncology Huntsville Alabama
United States Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana
United States Saint Vincent Hospital and Health Care Center Indianapolis Indiana
United States University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa
United States Green Bay Oncology - Iron Mountain Iron Mountain Michigan
United States Allegiance Health Jackson Michigan
United States Saint Dominic-Jackson Memorial Hospital Jackson Mississippi
United States University of Mississippi Medical Center Jackson Mississippi
United States Onslow Memorial Hospital Jacksonville North Carolina
United States Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina
United States McFarland Clinic PC-Jefferson Jefferson Iowa
United States West Michigan Cancer Center Kalamazoo Michigan
United States Kalispell Regional Medical Center Kalispell Montana
United States CHI Health Good Samaritan Kearney Nebraska
United States Novant Health Cancer Institute - Kernersville Kernersville North Carolina
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States University of Tennessee - Knoxville Knoxville Tennessee
United States UC San Diego Moores Cancer Center La Jolla California
United States IU Health La Porte Hospital La Porte Indiana
United States Carolina Blood and Cancer Care Associates PA-Lancaster Lancaster South Carolina
United States Sparrow Hospital Lansing Michigan
United States Women's Cancer Center of Nevada Las Vegas Nevada
United States MD Anderson League City League City Texas
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire
United States Geisinger Medical Oncology-Lewisburg Lewisburg Pennsylvania
United States Lewistown Hospital Lewistown Pennsylvania
United States University of Kentucky/Markey Cancer Center Lexington Kentucky
United States Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Saint Mary Mercy Hospital Livonia Michigan
United States Logan Regional Hospital Logan Utah
United States Texas Oncology-Longview Cancer Center Longview Texas
United States Cedars Sinai Medical Center Los Angeles California
United States Kaiser Permanente Los Angeles Medical Center Los Angeles California
United States Los Angeles County-USC Medical Center Los Angeles California
United States UCLA / Jonsson Comprehensive Cancer Center Los Angeles California
United States USC / Norris Comprehensive Cancer Center Los Angeles California
United States Lowell General Hospital Lowell Massachusetts
United States Illinois CancerCare-Macomb Macomb Illinois
United States University of Wisconsin Hospital and Clinics Madison Wisconsin
United States Holy Family Memorial Hospital Manitowoc Wisconsin
United States McFarland Clinic PC-Marshalltown Marshalltown Iowa
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Mercy Medical Center - North Iowa Mason City Iowa
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Hillcrest Hospital Cancer Center Mayfield Heights Ohio
United States UH Seidman Cancer Center at Lake Health Mentor Campus Mentor Ohio
United States Midstate Medical Center Meriden Connecticut
United States Franciscan Saint Anthony Health-Michigan City Michigan City Indiana
United States Woodland Cancer Care Center Michigan City Indiana
United States Memorial Sloan Kettering Monmouth Middletown New Jersey
United States Medical College of Wisconsin Milwaukee Wisconsin
United States NYU Winthrop Hospital Mineola New York
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States University of Minnesota/Masonic Cancer Center Minneapolis Minnesota
United States Michiana Hematology Oncology PC-Mishawaka Mishawaka Indiana
United States Saint Joseph Regional Medical Center-Mishawaka Mishawaka Indiana
United States Monroe Cancer Center Monroe Michigan
United States Monongalia Hospital Morgantown West Virginia
United States Morristown Medical Center Morristown New Jersey
United States Novant Health Cancer Institute - Mount Airy Mount Airy North Carolina
United States Virtua Memorial Mount Holly New Jersey
United States Palo Alto Medical Foundation-Gynecologic Oncology Mountain View California
United States ProHealth D N Greenwald Center Mukwonago Wisconsin
United States Intermountain Medical Center Murray Utah
United States Mercy Health Mercy Campus Muskegon Michigan
United States The Hospital of Central Connecticut New Britain Connecticut
United States Yale University New Haven Connecticut
United States UC Comprehensive Cancer Center at Silver Cross New Lenox Illinois
United States Ochsner Medical Center Jefferson New Orleans Louisiana
United States Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York
United States Memorial Sloan Kettering Cancer Center New York New York
United States Mount Sinai Hospital New York New York
United States Mount Sinai Union Square New York New York
United States NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York
United States Christiana Care Health System-Christiana Hospital Newark Delaware
United States Christiana Gynecologic Oncology LLC Newark Delaware
United States Helen F Graham Cancer Center Newark Delaware
United States Medical Oncology Hematology Consultants PA Newark Delaware
United States Yale-New Haven Hospital North Haven Medical Center North Haven Connecticut
United States Cancer Care Center of O'Fallon O'Fallon Illinois
United States Kaiser Permanente-Oakland Oakland California
United States ProHealth Oconomowoc Memorial Hospital Oconomowoc Wisconsin
United States Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls Wisconsin
United States McKay-Dee Hospital Center Ogden Utah
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Nebraska Methodist Hospital Omaha Nebraska
United States University of Nebraska Medical Center Omaha Nebraska
United States Saint Joseph Hospital - Orange Orange California
United States Smilow Cancer Hospital-Orange Care Center Orange Connecticut
United States UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California
United States University of Chicago Medicine-Orland Park Orland Park Illinois
United States AdventHealth Orlando Orlando Florida
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Palo Alto Medical Foundation Health Care Palo Alto California
United States Stanford Cancer Institute Palo Alto Palo Alto California
United States Keck Medical Center of USC Pasadena Pasadena California
United States Illinois CancerCare-Pekin Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Temple University Hospital Philadelphia Pennsylvania
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States University of Pennsylvania/Abramson Cancer Center Philadelphia Pennsylvania
United States Arizona Oncology Associates-Biltmore Cancer Center Phoenix Arizona
United States Cancer Center at Saint Joseph's Phoenix Arizona
United States Saint Joseph's Hospital and Medical Center Phoenix Arizona
United States FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst North Carolina
United States University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania
United States UPMC-Magee Womens Hospital Pittsburgh Pennsylvania
United States UPMC-Passavant Hospital Pittsburgh Pennsylvania
United States Saint Joseph Mercy Oakland Pontiac Michigan
United States Lake Huron Medical Center Port Huron Michigan
United States Geisinger Cancer Services-Pottsville Pottsville Pennsylvania
United States Illinois CancerCare-Princeton Princeton Illinois
United States Women and Infants Hospital Providence Rhode Island
United States Utah Valley Regional Medical Center Provo Utah
United States Duke Raleigh Hospital Raleigh North Carolina
United States Black Hills Obstetrics and Gynecology Rapid City South Dakota
United States Rapid City Regional Hospital Rapid City South Dakota
United States Spectrum Health Reed City Hospital Reed City Michigan
United States Beebe Health Campus Rehoboth Beach Delaware
United States Center of Hope at Renown Medical Center Reno Nevada
United States Renown Regional Medical Center Reno Nevada
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States Henrico Doctor's Hospital Richmond Virginia
United States Virginia Commonwealth University/Massey Cancer Center Richmond Virginia
United States Virginia Gynecologic Oncology Richmond Virginia
United States Carilion Clinic Gynecological Oncology Roanoke Virginia
United States Mayo Clinic in Rochester Rochester Minnesota
United States Carolina Blood and Cancer Care Associates PA Rock Hill South Carolina
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States Kaiser Permanente-Roseville Roseville California
United States William Beaumont Hospital-Royal Oak Royal Oak Michigan
United States Kaiser Permanente - Sacramento Sacramento California
United States University of California Davis Comprehensive Cancer Center Sacramento California
United States Ascension Saint Mary's Hospital Saginaw Michigan
United States Dixie Medical Center Regional Cancer Center Saint George Utah
United States Norris Cotton Cancer Center-North Saint Johnsbury Vermont
United States Barnes-Jewish Hospital Saint Louis Missouri
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Metro Minnesota Community Oncology Research Consortium Saint Louis Park Minnesota
United States Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota
United States United Hospital Saint Paul Minnesota
United States Women's Cancer Associates Saint Petersburg Florida
United States Huntsman Cancer Institute/University of Utah Salt Lake City Utah
United States LDS Hospital Salt Lake City Utah
United States Utah Cancer Specialists-Salt Lake City Salt Lake City Utah
United States California Pacific Medical Center-Pacific Campus San Francisco California
United States Kaiser Permanente-San Francisco San Francisco California
United States UCSF Medical Center-Mission Bay San Francisco California
United States UCSF Medical Center-Mount Zion San Francisco California
United States Zuckerberg San Francisco General Hospital San Francisco California
United States Kaiser Permanente-Santa Teresa-San Jose San Jose California
United States Kaiser Permanente San Leandro San Leandro California
United States Kaiser Permanente Medical Center - Santa Clara Santa Clara California
United States Palo Alto Medical Foundation-Santa Cruz Santa Cruz California
United States Sarasota Memorial Hospital Sarasota Florida
United States Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia
United States Maine Medical Center- Scarborough Campus Scarborough Maine
United States Fred Hutchinson Cancer Research Center Seattle Washington
United States Seattle Cancer Care Alliance Seattle Washington
United States University of Washington Medical Center - Montlake Seattle Washington
United States University of Washington Medical Center - Northwest Seattle Washington
United States Women's Cancer Center of Seattle Seattle Washington
United States UPMC Cancer Center at UPMC Northwest Seneca Pennsylvania
United States Avera Cancer Institute Sioux Falls South Dakota
United States Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States North Shore Medical Center Skokie Illinois
United States Memorial Sloan Kettering Sleepy Hollow Sleepy Hollow New York
United States Michiana Hematology Oncology PC-South Bend South Bend Indiana
United States Kaiser Permanente-South San Francisco South San Francisco California
United States Spartanburg Medical Center Spartanburg South Carolina
United States Baystate Medical Center Springfield Massachusetts
United States Cancer Research for the Ozarks NCORP Springfield Missouri
United States Central Illinois Hematology Oncology Center Springfield Illinois
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Geisinger Medical Group State College Pennsylvania
United States Novant Health Cancer Institute - Statesville Statesville North Carolina
United States Marshfield Clinic Stevens Point Center Stevens Point Wisconsin
United States Lakeview Hospital Stillwater Minnesota
United States Stony Brook University Medical Center Stony Brook New York
United States Green Bay Oncology - Sturgeon Bay Sturgeon Bay Wisconsin
United States Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay Wisconsin
United States Houston Methodist Sugar Land Hospital Sugar Land Texas
United States MD Anderson in Sugar Land Sugar Land Texas
United States Texas Oncology Cancer Center Sugar Land Sugar Land Texas
United States Overlook Hospital Summit New Jersey
United States Palo Alto Medical Foundation-Sunnyvale Sunnyvale California
United States Olive View-University of California Los Angeles Medical Center Sylmar California
United States ProMedica Flower Hospital Sylvania Ohio
United States MultiCare Tacoma General Hospital Tacoma Washington
United States Texas Oncology-The Woodlands The Woodlands Texas
United States Novant Health Cancer Institute - Thomasville Thomasville North Carolina
United States ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo Ohio
United States Smilow Cancer Hospital-Torrington Care Center Torrington Connecticut
United States Munson Medical Center Traverse City Michigan
United States William Beaumont Hospital - Troy Troy Michigan
United States Smilow Cancer Hospital Care Center-Trumbull Trumbull Connecticut
United States Arizona Oncology Associates-West Orange Grove Tucson Arizona
United States Arizona Oncology Associates-Wilmot Tucson Arizona
United States Banner University Medical Center - Tucson Tucson Arizona
United States University of Arizona Cancer Center-North Campus Tucson Arizona
United States Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa Oklahoma
United States Tyler Cancer Center Tyler Texas
United States Memorial Sloan Kettering Nassau Uniondale New York
United States UPMC Uniontown Hospital Radiation Oncology Uniontown Pennsylvania
United States Carle Cancer Center Urbana Illinois
United States The Carle Foundation Hospital Urbana Illinois
United States Westchester Medical Center Valhalla New York
United States Kaiser Permanente-Vallejo Vallejo California
United States MD Anderson Cancer Center at Cooper-Voorhees Voorhees New Jersey
United States Virtua Voorhees Voorhees New Jersey
United States John Muir Medical Center-Walnut Creek Walnut Creek California
United States Kaiser Permanente-Walnut Creek Walnut Creek California
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Northwestern Medicine Cancer Center Warrenville Warrenville Illinois
United States Smilow Cancer Hospital-Waterbury Care Center Waterbury Connecticut
United States ProHealth Waukesha Memorial Hospital Waukesha Wisconsin
United States UW Cancer Center at ProHealth Care Waukesha Wisconsin
United States Aspirus Regional Cancer Center Wausau Wisconsin
United States Marshfield Clinic-Wausau Center Wausau Wisconsin
United States Deke Slayton Cancer Center Webster Texas
United States Chester County Hospital West Chester Pennsylvania
United States Reading Hospital West Reading Pennsylvania
United States Marshfield Medical Center - Weston Weston Wisconsin
United States Michiana Hematology Oncology PC-Westville Westville Indiana
United States Dickstein Cancer Treatment Center White Plains New York
United States Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania
United States Novant Health Cancer Institute - Wilkesboro Wilkesboro North Carolina
United States Christiana Care Health System-Wilmington Hospital Wilmington Delaware
United States New Hanover Regional Medical Center/Zimmer Cancer Center Wilmington North Carolina
United States Novant Health Oncology Specialists Winston-Salem North Carolina
United States Wake Forest University Health Sciences Winston-Salem North Carolina
United States Winston-Salem Health Care Winston-Salem North Carolina
United States Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin
United States Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota
United States UMass Memorial Medical Center - Memorial Division Worcester Massachusetts
United States Wright-Patterson Medical Center Wright-Patterson Air Force Base Ohio
United States WellSpan Health-York Hospital York Pennsylvania
United States Rush-Copley Healthcare Center Yorkville Illinois

Sponsors (2)

Lead Sponsor Collaborator
Gynecologic Oncology Group National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Metabolic Factor Levels Hip-to-waist ratio, diabetes status, hemoglobin A1c, fasting insulin glucose levels, and homeostatic model assessment scores will be assessed for their predictive and prognostic significance. Variables will be analyzed as continuous covariates (or as appropriate with transformations such as the logarithm) with Cox models or logistic regression. Up to 5 years
Other Incidence of PIK3 Mutations/Amplifications PIK3CA mutations/amplifications and PIK3R1/PIK3R2 mutations will be examined for prognostic and predictive significance. Up to 5 years
Other Expression of MATE 2 Expression will be examined by immunohistochemistry with intensity of staining and the percentage of cells staining positive. From these statistics, an H-score will be calculated. Expression will be further dichotomized as high expression and low expression at the median to maximize the power of the study. Up to 5 years
Other Levels of Key Targets of the Metformin/mTOR Signaling Pathway Levels before and after treatment will be assessed for their predictive and prognostic significance. Up to 5 years
Primary Progression-free Survival (PFS) (Phase II) Time until disease progression, death, or date of last contact. This study was originally designed as a phase II/III study. It passed the phase 2 threshold and started the phase 3; however, a phase 3 interim analysis stopped the trial for futility. Therefore, data available for Phase III may be identical to data reported for Phase II or Phase II/III combined. From date of study entry to time of progression or death, whichever occurs first, assessed up to 5 years
Primary Overall Survival (OS) (Phase II and III) The observed length of life from randomization into the study to death or the date of last contact. This study was originally designed as a phase II/III study. It passed the phase 2 threshold and started the phase 3; however, a phase 3 interim analysis stopped the trial for futility. Therefore, data available for Phase III may be identical to data reported for Phase II or Phase II/III combined. From date of study entry to time of death or the date of last contact, assessed up to 5 years
Secondary Proportion of Patients Responding to Therapy The proportion of patients who had a response (complete or partial) by RECIST 1.1. Measurable disease is defined by RECIST (version 1.1). Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be = 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or = 20 mm when measured by chest x-ray. Lymph nodes must be > 15 mm in short axis when measured by CT or MRI. During study treatment, up to 5 years.
Secondary Duration of Response by Treatment Duration of response until disease progression, death, or date last seen among patients who responded. From the date of response to disease progression, death, or date last seen assessed up to 5 years
Secondary Overall Survival (OS) (Phase II) The observed length of life from randomization into the study to death or the date of last contact. For response, only those patients who had measurable disease were included in an analysis of response. Non-measurable patients are included in the ITT analysis. This study was originally designed as a phase II/III study. It passed the phase 2 threshold and started the phase 3; however, a phase 3 interim analysis stopped the trial for futility. Therefore, data available for Phase III may be identical to data reported for Phase II or Phase II/III combined. From date of study entry to time of death or the date of last contact, assessed up to 5 years.
Secondary Progression Free Survival (PFS) (Phase III) Time until disease progression, death, or date of last contact. For response, only those patients who had measurable disease were included in an analysis of response. Non-measurable patients are included in the ITT analysis. This study was originally designed as a phase II/III study. It passed the phase 2 threshold and started the phase 3; however, a phase 3 interim analysis stopped the trial for futility. Therefore, data available for Phase III may be identical to data reported for Phase II or Phase II/III combined. From date of study entry to time of progression or death, whichever occurs first, assessed up to 5 years
Secondary Number of Participants With Grade 3 or Higher Adverse Events as Assessed by Common Terminology Criteria for Adverse Events Version 4 Toxicities will be assessed by organ or organ system. For each category of toxicity, each patient will be evaluated by the worst grade experienced during the course of therapy. Data will be summarized by frequency and severity according to the regimen administered. The number of patients with a grade three or greater adverse event will be reported (by system organ class). Up to 5 years
Secondary Level of Obesity Obesity will be quantitative assessed by body mass index (BMI) and will be assessed for its predictive and prognostic significance. The interaction between BMI and metformin treatment will be examined with an interaction term in a Cox proportional hazards model. Up to 5 years
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