Clinical trial NCT01168791: Study of Palifosfamide-tris in Combination With Doxorubicin in Patients With Front-line Metastatic Soft Tissue Sarcoma
Official title: A Phase III Multicenter, International, Randomized, Double-blind, Placebo-controlled Study of Doxorubicin Plus Palifosfamide-tris vs. Doxorubicin Plus Placebo in Patients With Front-line Metastatic Soft Tissue Sarcoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Soft Tissue Sarcoma
Keywords: Metastatic
Front line
Lead sponsor: Alaunos Therapeutics
Sponsor class: INDUSTRY
First posted: 2010-07-23
Enrollment: 447
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: To be eligible, each patient must meet EACH of the following criteria:

* Age ≥18 years.
* Documented soft tissue sarcoma
* Metastatic disease for which the patient has not received any prior treatment, and for whom treatment with doxorubicin is considered medically acceptable.
* ECOG Performance Status of 0, 1 or 2
* Adequate bone marrow and organ function based on the results of protocol- specified laboratory tests
* Male and female patients must agree to use a highly reliable method of birth control during study participation.
* Able to provide informed consent

To be eligible, each patient must meet NONE of the following criteria:

* Specific sarcoma histological subtypes including GIST and Ewing's sarcoma.
* Systemic therapy for the treatment of metastatic sarcoma, prior to or during the study. However, patients may have received neo-adjuvant/adjuvant Gemzar and Taxotere chemotherapy for their primary sarcoma, prior to the development of metastatic disease
* Any prior anthracycline use.
* Known allergy to any of the study drugs or their excipients.
* Any unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a patient and/or their compliance with the protocol, based on screening tests, physical examination and medical history (as specifically defined in the clinical protocol).
* Myocardial dysfunction defined as left ventricular ejection fraction (LVEF) \<50%.
* Documented metastases to brain or meninges.
* Any malignancy other than sarcoma within the last 5 years prior to screening, with the exception of cervical carcinoma in situ, basal cell carcinoma, or superficial bladder tumors (Ta, Tis, or T1) that have been successfully and curatively treated with no evidence of recurrent or residual disease.
* Currently pregnant or nursing.
* Radiotherapy with curative intent within 4 weeks of first dose of study drug.

Primary outcomes:
measure: Progression Free Survival followed by Overall Survival
timeFrame: assessed every 6 weeks for 22 weeks, then 8 weeks for 6 months/until progression, then every 12 weeks until then death
Secondary outcomes:
measure: Quality of Life, as assessed by EORTC QLQ-C30 and EQ-5D questionnaires
timeFrame: assessed every 6 weeks for 22 weeks, then 8 weeks for 6 months, then every 12 weeks until death
measure: Safety and Tolerability as evaluated using CTCAE v 4.0
timeFrame: 22 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Phoenix
country: United States
facility: Arizona Oncology Associates
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Los Angeles
country: United States
state: California
city: Orange
country: United States
facility: University of California, Irvine
state: California
city: Pomona
country: United States
state: California
city: Santa Monica
country: United States
facility: Sarcoma Oncology Center
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Newark
country: United States
facility: Medical Oncology Hematology Consultants
state: Delaware
city: Washington
country: United States
facility: MedStar Research Institute
state: District of Columbia
city: Washington
country: United States
state: District of Columbia
city: Jacksonville
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Cancer Institute
state: Florida
city: Atlanta
country: United States
facility: Emory
state: Georgia
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Post Falls
country: United States
facility: Kootenai Cancer Center
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Park Ridge
country: United States
state: Illinois
city: Indiannapolis
country: United States
facility: Indiana University Simon Cancer Center
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospital and Clinics
state: Iowa
city: Overland Park
country: United States
facility: Kansas City Cancer Center
state: Kansas
city: New Orleans
country: United States
state: Louisiana
city: Shreveport
country: United States
facility: LSU Health Sciences Center, Feist-Weiller Cancer Center
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: St. Louis
country: United States
facility: St.Louis University
state: Missouri
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: Hackensack
country: United States
state: New Jersey
city: Morristown
country: United States
state: New Jersey
city: West Orange
country: United States
facility: Saint Barnabas
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Bronx
country: United States
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Akron
country: United States
facility: Summa Health System
state: Ohio
city: Cinncinnati
country: United States
facility: UC Cancer Institute
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Tulsa
country: United States
facility: Cancer Care Associates
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Bethelehem
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Oncology/Hematology Associates
state: Pennsylvania
city: Pittsburg
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Charleston
country: United States
state: South Carolina
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Bedford
country: United States
facility: Texas Oncology
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Medical City Dallas
state: Texas
city: San Antonio
country: United States
facility: Cancer Therapy and Research Center
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Burlington
country: United States
state: Vermont
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Seattle
country: United States
facility: University of Washington/Seattle Cancer Care Alliance
state: Washington
city: Green Bay
country: United States
facility: Bellin Cancer Center
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Ciudad de Buenos Aires
country: Argentina
city: Cordoba
country: Argentina
city: Ramos Mejia
country: Argentina
city: Rosario
country: Argentina
facility: Instituto CAICI
city: Sante Fe
country: Argentina
city: Adelaide
country: Australia
facility: North Adelaide Oncology
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Camperdown
country: Australia
city: East Melbourne
country: Australia
city: Garran
country: Australia
facility: The Canberra Hospital
city: Garran
country: Australia
city: Kurralta Park
country: Australia
city: Nedlands
country: Australia
city: Randwick
country: Australia
facility: Prince of Wales Hospital
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
city: Antwerp
country: Belgium
city: Bruxelles
country: Belgium
city: Leuven
country: Belgium
city: Liege
country: Belgium
city: Barretos
country: Brazil
facility: Institution name: Hospital de Câncer de Barretos - Fundação PIOXII
city: Belo Horizonte
country: Brazil
city: Curitiba
country: Brazil
facility: Santa Casa da Misericórdia de Curitiba
city: Florianopolis
country: Brazil
city: Jau
country: Brazil
city: Passo Fundo
country: Brazil
facility: Hospital da Cidade de Passo Fundo
city: Porto Alegre
country: Brazil
facility: Hospital das Clínicas de Porto Alegre
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre
city: Salvador
country: Brazil
facility: Centro de Oncologia da Bahia
city: Sao Paulo
country: Brazil
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montreal
country: Canada
facility: McGill University
state: Quebec
city: Santiago
country: Chile
city: Temuco
country: Chile
facility: Instituto Clínico Oncológico del Sur
city: Vina del Mar
country: Chile
city: Bogota
country: Colombia
city: Medellin
country: Colombia
city: Monteria
country: Colombia
city: Angers
country: France
city: Bordeaux
country: France
city: Marseilles
country: France
facility: Institut Paoli Calmettes
city: Marseille
country: France
city: Montpellier
country: France
city: Nice
country: France
city: Paris
country: France
city: Toulouse
country: France
city: Villejuif
country: France
city: Bad Sarrow
country: Germany
facility: HELIOS Klinikum Berlin Buch
city: Hannover
country: Germany
city: Koln
country: Germany
facility: Universitätsklinikum Köln
city: Mannheim
country: Germany
city: Tuebingen
country: Germany
facility: Tuebingen University Hospital
city: Guatemala
country: Guatemala
city: Jaipur
country: India
city: Mumbai
country: India
city: Nasik
country: India
city: Pune
country: India
city: Secunderabad
country: India
city: Haifa
country: Israel
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
city: Petach Tikva
country: Israel
city: Ramat Gan
country: Israel
city: Ramat-Gan
country: Israel
city: Tel Aviv
country: Israel
city: Candiolo
country: Italy
city: Rozzana
country: Italy
facility: Humanitas Cancer Center
city: Torino
country: Italy
facility: Ospedale Gradenigo Oncology
city: Panama
country: Panama
facility: Centro Hemato Oncologico Paitilla
city: Panama
country: Panama
facility: Medical and Research Center
city: Gdansk
country: Poland
facility: Wojewodzkie Centrum Onkologii
city: Gilwice
country: Poland
city: Warszawa
country: Poland
facility: Centrum Onkologii Instytut
city: Bucharest
country: Romania
city: Cluj Napoca
country: Romania
city: Craiova
country: Romania
city: Moscow
country: Russian Federation
city: Obninsk
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Singapore
country: Singapore
city: Badalona
country: Spain
city: Madrid
country: Spain
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Valencia
country: Spain
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust Sarcoma
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Foundation Trust
Study officials:
References:
citation: Ryan CW, Merimsky O, Agulnik M, Blay JY, Schuetze SM, Van Tine BA, Jones RL, Elias AD, Choy E, Alcindor T, Keedy VL, Reed DR, Taub RN, Italiano A, Garcia Del Muro X, Judson IR, Buck JY, Lebel F, Lewis JJ, Maki RG, Schoffski P. PICASSO III: A Phase III, Placebo-Controlled Study of Doxorubicin With or Without Palifosfamide in Patients With Metastatic Soft Tissue Sarcoma. J Clin Oncol. 2016 Nov 10;34(32):3898-3905. doi: 10.1200/JCO.2016.67.6684. Epub 2016 Sep 30.