Study of Palifosfamide-tris in Combination With Doxorubicin in Patients With Front-line Metastatic Soft Tissue Sarcoma

PHASE3CompletedINTERVENTIONAL
Enrollment

447

Participants

Timeline

Start Date

July 31, 2010

Primary Completion Date

March 31, 2013

Study Completion Date

March 31, 2013

Conditions
Soft Tissue Sarcoma
Interventions
DRUG

doxorubicin in combination with palifosfamide-tris

"palifosfamide-tris: 150 mg/m2 3 days every 21 days for a maximum of 6 cycles.~doxorubicin: 75 mg/m2 1 day every 21 days for a maximum of 6 cycles."

DRUG

doxorubicin in combination with placebo

"doxorubicin: 75 mg/m2 of doxorubicin 1 day every 21 days for a maximum of 6 cycles.~placebo: 250 mL of normal saline 3 days every 21 days for a maximum of 6 cycles."

Trial Locations (161)

4102

Princess Alexandra Hospital, Woolloongabba

8229

Cancer Therapy and Research Center, San Antonio

10029

Mount Sinai School of Medicine, New York

15232

University of Pittsburgh, Pittsburgh

54313

Bellin Cancer Center, Green Bay

63110

St.Louis University, St Louis

72205

University of Arkansas for Medical Sciences, Little Rock

83854

Kootenai Cancer Center, Post Falls

85724

Arizona Cancer Center, Tucson

Unknown

Birmingham

Arizona Oncology Associates, Phoenix

Scottsdale

University of California, Los Angeles, Los Angeles

Los Angeles

University of California, Irvine, Orange

Pomona

Sarcoma Oncology Center, Santa Monica

University of Colorado Cancer Center, Aurora

Rocky Mountain Cancer Centers, Denver

Medical Oncology Hematology Consultants, Newark

MedStar Research Institute, Washington D.C.

Washington D.C.

Jacksonville

Orlando

Moffitt Cancer Center, Tampa

Palm Beach Cancer Institute, West Palm Beach

Emory, Atlanta

Medical College of Georgia, Augusta

Chicago

Park Ridge

Indiana University Simon Cancer Center, Indiannapolis

University of Iowa Hospital and Clinics, Iowa City

Kansas City Cancer Center, Overland Park

New Orleans

LSU Health Sciences Center, Feist-Weiller Cancer Center, Shreveport

Baltimore

Dana-Farber Cancer Institute, Boston

Ann Arbor

Mayo Clinic, Rochester

Washington University School of Medicine, St Louis

Las Vegas

Hackensack

Morristown

Saint Barnabas, West Orange

Albuquerque

Columbia University Medical Center, New York

University of Rochester, Rochester

The Bronx

University of North Carolina, Chapel Hill

Durham

Raleigh

Wake Forest University Health Sciences, Winston-Salem

Summa Health System, Akron

UC Cancer Institute, Cinncinnati

Cleveland Clinic, Cleveland

The Ohio State University Medical Center, Columbus

Cancer Care Associates, Tulsa

Oregon Health and Science University, Portland

Bethelehem

Fox Chase Cancer Center, Philadelphia

Pennsylvania Oncology/Hematology Associates, Philadelphia

Providence

Charleston

Cancer Centers of the Carolinas, Greenville

Memphis

Nashville

Texas Oncology, Bedford

Texas Oncology - Medical City Dallas, Dallas

Utah Cancer Specialists, Salt Lake City

Burlington

Virginia Cancer Specialists, Fairfax

University of Washington/Seattle Cancer Care Alliance, Seattle

University of Wisconsin, Madison

Milwaukee

Ciudad de Buenos Aires

Córdoba

Ramos Mejía

Instituto CAICI, Rosario

Sante Fe

Royal Adelaide Hospital, Adelaide

Camperdown

East Melbourne

The Canberra Hospital, Garran

Garran

Kurralta Park

Nedlands

Antwerp

Brussels

Leuven

Liège

Institution name: Hospital de Câncer de Barretos - Fundação PIOXII, Barretos

Belo Horizonte

Santa Casa da Misericórdia de Curitiba, Curitiba

Florianópolis

Jaú

Hospital da Cidade de Passo Fundo, Passo Fundo

Hospital das Clínicas de Porto Alegre, Porto Alegre

Irmandade da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre

Centro de Oncologia da Bahia, Salvador

São Paulo

Calgary

Cross Cancer Institute, Edmonton

Mount Sinai Hospital, Toronto

Jewish General Hospital, Montreal

McGill University, Montreal

Santiago

Instituto Clínico Oncológico del Sur, Temuco

Viña del Mar

Bogotá

Medellín

Montería

Angers

Bordeaux

Institut Paoli Calmettes, Marseille

Marseille

Montpellier

Nice

Paris

Toulouse

Villejuif

HELIOS Klinikum Berlin Buch, Bad Sarrow

Universitätsklinikum Köln, Cologne

Hanover

Mannheim

Tuebingen University Hospital, Tübingen

Guatemala City

Jaipur

Mumbai

Nashik

Pune

Secunderabad

Haifa

Shaare Zedek Medical Center, Jerusalem

Jerusalem

Petah Tikva

Ramat Gan

Tel Aviv

Candiolo

Humanitas Cancer Center, Rozzana

Ospedale Gradenigo Oncology, Torino

Centro Hemato Oncologico Paitilla, Panama City

Medical and Research Center, Panama City

Wojewodzkie Centrum Onkologii, Gdansk

Gilwice

Centrum Onkologii Instytut, Warsaw

Bucharest

Cluj-Napoca

Craiova

Moscow

Obninsk

Saint Petersburg

Yaroslavl

Singapore

Badalona

Madrid

Hospital Universitario Puerta de Hierro, Majadahonda

Valencia

Christie Hospital NHS Foundation Trust, Manchester

SA 5006

North Adelaide Oncology, Adelaide

NSW 2031

Prince of Wales Hospital, Randwick

SW3 6JJ

The Royal Marsden NHS Foundation Trust Sarcoma, London

Sponsors
All Listed Sponsors
lead

Alaunos Therapeutics

INDUSTRY