Study of Palifosfamide-tris in Combination With Doxorubicin in Patients With Front-line Metastatic Soft Tissue Sarcoma
- Conditions
- Soft Tissue Sarcoma
- Interventions
- Registration Number
- NCT01168791
- Lead Sponsor
- Alaunos Therapeutics
- Brief Summary
This is an international, randomized, double-blind, placebo-controlled trial to evaluate the clinical efficacy of palifosfamide-tris administered with doxorubicin in combination, compared with doxorubicin administered with placebo in front-line patients diagnosed with metastatic soft tissue sarcoma (STS).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 447
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description doxorubicin plus palifosfamide-tris doxorubicin in combination with palifosfamide-tris - doxorubicin plus placebo doxorubicin in combination with placebo -
- Primary Outcome Measures
Name Time Method Progression Free Survival followed by Overall Survival assessed every 6 weeks for 22 weeks, then 8 weeks for 6 months/until progression, then every 12 weeks until then death
- Secondary Outcome Measures
Name Time Method Quality of Life, as assessed by EORTC QLQ-C30 and EQ-5D questionnaires assessed every 6 weeks for 22 weeks, then 8 weeks for 6 months, then every 12 weeks until death Safety and Tolerability as evaluated using CTCAE v 4.0 22 weeks
Trial Locations
- Locations (78)
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
University of California, Los Angeles
🇺🇸Los Angeles, California, United States
University of California, Irvine
🇺🇸Orange, California, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Cancer Therapy and Research Center
🇺🇸San Antonio, Texas, United States
Kansas City Cancer Center
🇺🇸Overland Park, Kansas, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
University of Rochester
🇺🇸Rochester, New York, United States
Arizona Oncology Associates
🇺🇸Phoenix, Arizona, United States
Utah Cancer Specialists
🇺🇸Salt Lake City, Utah, United States
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
UC Cancer Institute
🇺🇸Cinncinnati, Ohio, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Summa Health System
🇺🇸Akron, Ohio, United States
Royal Adelaide Hospital
🇦🇺Adelaide, Australia
North Adelaide Oncology
🇦🇺Adelaide, Australia
The Canberra Hospital
🇦🇺Garran, Australia
Institut Paoli Calmettes
🇫🇷Marseilles, France
Universitätsklinikum Köln
🇩🇪Koln, Germany
Instituto Clínico Oncológico del Sur
🇨🇱Temuco, Chile
McGill University
🇨🇦Montreal, Quebec, Canada
Ospedale Gradenigo Oncology
🇮🇹Torino, Italy
Medical and Research Center
🇵🇦Panama, Panama
HELIOS Klinikum Berlin Buch
🇩🇪Bad Sarrow, Germany
Sarcoma Oncology Center
🇺🇸Santa Monica, California, United States
MedStar Research Institute
🇺🇸Washington, District of Columbia, United States
Medical College of Georgia
🇺🇸Augusta, Georgia, United States
University of Iowa Hospital and Clinics
🇺🇸Iowa City, Iowa, United States
Saint Barnabas
🇺🇸West Orange, New Jersey, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Virginia Cancer Specialists
🇺🇸Fairfax, Virginia, United States
Instituto CAICI
🇦🇷Rosario, Argentina
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Tuebingen University Hospital
🇩🇪Tuebingen, Germany
Centro Hemato Oncologico Paitilla
🇵🇦Panama, Panama
Humanitas Cancer Center
🇮🇹Rozzana, Italy
Wojewodzkie Centrum Onkologii
🇵🇱Gdansk, Poland
Centrum Onkologii Instytut
🇵🇱Warszawa, Poland
Hospital Universitario Puerta de Hierro
🇪🇸Majadahonda, Spain
The Royal Marsden NHS Foundation Trust Sarcoma
🇬🇧London, United Kingdom
Christie Hospital NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Kootenai Cancer Center
🇺🇸Post Falls, Idaho, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Palm Beach Cancer Institute
🇺🇸West Palm Beach, Florida, United States
Emory
🇺🇸Atlanta, Georgia, United States
Medical Oncology Hematology Consultants
🇺🇸Newark, Delaware, United States
Indiana University Simon Cancer Center
🇺🇸Indiannapolis, Indiana, United States
LSU Health Sciences Center, Feist-Weiller Cancer Center
🇺🇸Shreveport, Louisiana, United States
St.Louis University
🇺🇸St. Louis, Missouri, United States
Cancer Care Associates
🇺🇸Tulsa, Oklahoma, United States
Texas Oncology - Medical City Dallas
🇺🇸Dallas, Texas, United States
University of Pittsburgh
🇺🇸Pittsburg, Pennsylvania, United States
Pennsylvania Oncology/Hematology Associates
🇺🇸Philadelphia, Pennsylvania, United States
Cancer Centers of the Carolinas
🇺🇸Greenville, South Carolina, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Princess Alexandra Hospital
🇦🇺Woolloongabba, Australia
Irmandade da Santa Casa de Misericórdia de Porto Alegre
🇧🇷Porto Alegre, Brazil
Texas Oncology
🇺🇸Bedford, Texas, United States
Bellin Cancer Center
🇺🇸Green Bay, Wisconsin, United States
Centro de Oncologia da Bahia
🇧🇷Salvador, Brazil
University of Washington/Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
Prince of Wales Hospital
🇦🇺Randwick, Australia
Santa Casa da Misericórdia de Curitiba
🇧🇷Curitiba, Brazil
Institution name: Hospital de Câncer de Barretos - Fundação PIOXII
🇧🇷Barretos, Brazil
Hospital da Cidade de Passo Fundo
🇧🇷Passo Fundo, Brazil
Hospital das Clínicas de Porto Alegre
🇧🇷Porto Alegre, Brazil
University of Colorado Cancer Center
🇺🇸Aurora, Colorado, United States
Rocky Mountain Cancer Centers
🇺🇸Denver, Colorado, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States