Efatutazone Dihydrochloride in Treating Patients With Previously Treated Myxoid Liposarcoma That Cannot Be Removed by Surgery
- Registration Number
- NCT02249949
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
This phase II trial studies how well efatutazone dihydrochloride works in treating patients with previously treated myxoid liposarcoma that cannot be removed by surgery. Drugs used in chemotherapy, such as efatutazone dihydrochloride, 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.
- Detailed Description
PRIMARY OBJECTIVES:
I. To determine the confirmed response rate for efatutazone dihydrochloride (efatutazone) in patients with advanced myxoid liposarcoma whose disease has progressed on at least one prior therapy.
SECONDARY OBJECTIVES:
I. To assess the progression free survival (PFS), overall survival (OS), and adverse event rates for efatutazone treated patients with advanced myxoid liposarcoma whose disease has progressed on at least one prior therapy.
TERTIARY OBJECTIVES:
I. To assess the predictive value of peroxisome proliferator-activated receptor (PPAR) and retinoid X receptors (RXR) tumor expression from archived patient tumor samples.
II. To assess the predictive value of the expression of PPARgamma-regulated markers of adipocytes differentiation.
III. To assess the predictive value of the expression of PPARgamma-regulated cell cycle proteins.
IV. To assess the effects of efatutazone treatment on serum adiponectin levels.
OUTLINE:
Patients receive efatutazone dihydrochloride orally (PO) twice daily (BID) continuously. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 12 weeks for 2 years and then every 6 months for up to 5 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description efatutazone dihydrochloride efatutazone Patients receive efatutazone dihydrochloride PO BID continuously. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- Primary Outcome Measures
Name Time Method Confirmed Overall Response Rate Per the RECIST 1.1 Criteria Up to 24 weeks (8 cycles) The response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients.
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS) Determined Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Time from study entry to the first of either disease progression or death from any cause, assessed up to 5 years Progression free survival (PFS) is defined as the time from study entry to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Overall Survival Time from study entry to death from any cause, assessed up to 5 years Overall survival time is defined as the time from study entry to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Incidence of Grade 3+ Adverse Events Summarized Using Common Terminology Criteria for Adverse Events Version 4.0 Up to 5 years Incidence of grade 3+ adverse events summarized using Common Terminology Criteria for Adverse Events version 4.0: The frequency and percentage of grade 3+ adverse events will be estimated
Trial Locations
- Locations (127)
Northside Hospital
🇺🇸Atlanta, Georgia, United States
Rush - Copley Medical Center
🇺🇸Aurora, Illinois, United States
Illinois CancerCare-Canton
🇺🇸Canton, Illinois, United States
Decatur Memorial Hospital
🇺🇸Decatur, Illinois, United States
Illinois CancerCare-Galesburg
🇺🇸Galesburg, Illinois, United States
Western Illinois Cancer Treatment Center
🇺🇸Galesburg, Illinois, United States
Illinois CancerCare-Macomb
🇺🇸Macomb, Illinois, United States
Menorah Medical Center
🇺🇸Overland Park, Kansas, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
State University of New York Upstate Medical University
🇺🇸Syracuse, New York, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Illinois CancerCare-Peoria
🇺🇸Peoria, Illinois, United States
Mercy Hospital Joplin
🇺🇸Joplin, Missouri, United States
Saint Luke's East - Lee's Summit
🇺🇸Lee's Summit, Missouri, United States
Norris Cotton Cancer Center-North
🇺🇸Saint Johnsbury, Vermont, United States
Abbott-Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Mercy Hospital Springfield
🇺🇸Springfield, Missouri, United States
Capital Region Southwest Campus
🇺🇸Jefferson City, Missouri, United States
Sainte Genevieve County Memorial Hospital
🇺🇸Sainte Genevieve, Missouri, United States
Missouri Baptist Outpatient Center-Sunset Hills
🇺🇸Sunset Hills, Missouri, United States
Mercy Hospital Washington
🇺🇸Washington, Missouri, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Integris Southwest Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Integris Cancer Institute of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Freeman Health System
🇺🇸Joplin, Missouri, United States
MedStar Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
Hawaii Oncology Inc-Pali Momi
🇺🇸'Aiea, Hawaii, United States
Northside Hospital-Forsyth
🇺🇸Cumming, Georgia, United States
Pali Momi Medical Center
🇺🇸'Aiea, Hawaii, United States
The Cancer Center of Hawaii-Pali Momi
🇺🇸'Aiea, Hawaii, United States
Wilcox Memorial Hospital and Kauai Medical Clinic
🇺🇸Lihue, Hawaii, United States
Illinois CancerCare-Bloomington
🇺🇸Bloomington, Illinois, United States
Saint Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
Memorial Hospital of Carbondale
🇺🇸Carbondale, Illinois, United States
SIH Cancer Institute
🇺🇸Carterville, Illinois, United States
Illinois CancerCare-Carthage
🇺🇸Carthage, Illinois, United States
Carle on Vermilion
🇺🇸Danville, Illinois, United States
Centralia Oncology Clinic
🇺🇸Centralia, Illinois, United States
Cancer Care Specialists of Central Illinois
🇺🇸Decatur, Illinois, United States
Carle Physician Group-Effingham
🇺🇸Effingham, Illinois, United States
Crossroads Cancer Center
🇺🇸Effingham, Illinois, United States
Illinois CancerCare-Eureka
🇺🇸Eureka, Illinois, United States
Illinois CancerCare-Kewanee Clinic
🇺🇸Kewanee, Illinois, United States
Carle Physician Group-Mattoon/Charleston
🇺🇸Mattoon, Illinois, United States
Good Samaritan Regional Health Center
🇺🇸Mount Vernon, Illinois, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Illinois CancerCare-Ottawa Clinic
🇺🇸Ottawa, Illinois, United States
Radiation Oncology of Northern Illinois
🇺🇸Ottawa, Illinois, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
🇺🇸Pekin, Illinois, United States
Illinois CancerCare-Pekin
🇺🇸Pekin, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
🇺🇸Peoria, Illinois, United States
OSF Saint Francis Medical Center
🇺🇸Peoria, Illinois, United States
Illinois CancerCare-Peru
🇺🇸Peru, Illinois, United States
Valley Radiation Oncology
🇺🇸Peru, Illinois, United States
Illinois CancerCare-Princeton
🇺🇸Princeton, Illinois, United States
Central Illinois Hematology Oncology Center
🇺🇸Springfield, Illinois, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
Springfield Clinic
🇺🇸Springfield, Illinois, United States
Memorial Medical Center
🇺🇸Springfield, Illinois, United States
Cancer Care Specialists of Illinois-Swansea
🇺🇸Swansea, Illinois, United States
Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Memorial and Saint Elizabeth's Health Care Services LLP
🇺🇸Swansea, Illinois, United States
The Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Franciscan Saint Anthony Health-Michigan City
🇺🇸Michigan City, Indiana, United States
Kansas Institute of Medicine Cancer and Blood Center
🇺🇸Lenexa, Kansas, United States
Woodland Cancer Care Center
🇺🇸Michigan City, Indiana, United States
Rush-Copley Healthcare Center
🇺🇸Yorkville, Illinois, United States
Deaconess Clinic Downtown
🇺🇸Evansville, Indiana, United States
Chancellor Center for Oncology
🇺🇸Newburgh, Indiana, United States
Minimally Invasive Surgery Hospital
🇺🇸Lenexa, Kansas, United States
Saint Luke's South Hospital
🇺🇸Overland Park, Kansas, United States
Central Care Cancer Center - Bolivar
🇺🇸Bolivar, Missouri, United States
Saint Louis Cancer and Breast Institute-Ballwin
🇺🇸Ballwin, Missouri, United States
Parkland Health Center-Bonne Terre
🇺🇸Bonne Terre, Missouri, United States
Cox Cancer Center Branson
🇺🇸Branson, Missouri, United States
Saint Francis Medical Center
🇺🇸Cape Girardeau, Missouri, United States
Southeast Cancer Center
🇺🇸Cape Girardeau, Missouri, United States
Siteman Cancer Center at West County Hospital
🇺🇸Creve Coeur, Missouri, United States
Centerpoint Medical Center LLC
🇺🇸Independence, Missouri, United States
Delbert Day Cancer Institute at PCRMC
🇺🇸Rolla, Missouri, United States
Heartland Regional Medical Center
🇺🇸Saint Joseph, Missouri, United States
Mercy Clinic-Rolla-Cancer and Hematology
🇺🇸Rolla, Missouri, United States
Saint Louis Cancer and Breast Institute-South City
🇺🇸Saint Louis, Missouri, United States
Siteman Cancer Center-South County
🇺🇸Saint Louis, Missouri, United States
Mercy Hospital Saint Louis
🇺🇸Saint Louis, Missouri, United States
Missouri Baptist Medical Center
🇺🇸Saint Louis, Missouri, United States
CoxHealth South Hospital
🇺🇸Springfield, Missouri, United States
Norris Cotton Cancer Center-Manchester
🇺🇸Manchester, New Hampshire, United States
Missouri Baptist Sullivan Hospital
🇺🇸Sullivan, Missouri, United States
Norris Cotton Cancer Center-Nashua
🇺🇸Nashua, New Hampshire, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Columbia University/Herbert Irving Cancer Center
🇺🇸New York, New York, United States
University of New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Mercy Hospital Oklahoma City
🇺🇸Oklahoma City, Oklahoma, United States
Greenville Health System Cancer Institute-Andrews
🇺🇸Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Butternut
🇺🇸Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Easley
🇺🇸Easley, South Carolina, United States
Greenville Health System Cancer Institute-Eastside
🇺🇸Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Greer
🇺🇸Greer, South Carolina, United States
Greenville Memorial Hospital
🇺🇸Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Seneca
🇺🇸Seneca, South Carolina, United States
Greenville Health System Cancer Institute-Spartanburg
🇺🇸Spartanburg, South Carolina, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Hawaii Oncology Inc-POB I
🇺🇸Honolulu, Hawaii, United States
University of Hawaii Cancer Center
🇺🇸Honolulu, Hawaii, United States
Hawaii Oncology Inc-Kuakini
🇺🇸Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
🇺🇸Honolulu, Hawaii, United States
Hawaii Cancer Care Inc-POB II
🇺🇸Honolulu, Hawaii, United States
Island Urology
🇺🇸Honolulu, Hawaii, United States
Queen's Medical Center
🇺🇸Honolulu, Hawaii, United States
Straub Clinic and Hospital
🇺🇸Honolulu, Hawaii, United States
Hawaii Cancer Care Inc-Liliha
🇺🇸Honolulu, Hawaii, United States
Kuakini Medical Center
🇺🇸Honolulu, Hawaii, United States
The Cancer Center of Hawaii-Liliha
🇺🇸Honolulu, Hawaii, United States
Saint Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
Research Medical Center
🇺🇸Kansas City, Missouri, United States
Greenville Health System Cancer Institute-Faris
🇺🇸Greenville, South Carolina, United States