Study of Palifosfamide-tris in Combination With Doxorubicin in Patients With Front-line Metastatic Soft Tissue Sarcoma
NCT ID: NCT01168791
Last Updated: 2013-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
447 participants
INTERVENTIONAL
2010-07-31
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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doxorubicin plus palifosfamide-tris
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.
doxorubicin plus placebo
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Alaunos Therapeutics
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
Arizona Oncology Associates
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Arizona Cancer Center
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
University of California, Los Angeles
Los Angeles, California, United States
Los Angeles, California, United States
University of California, Irvine
Orange, California, United States
Pomona, California, United States
Sarcoma Oncology Center
Santa Monica, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Medical Oncology Hematology Consultants
Newark, Delaware, United States
MedStar Research Institute
Washington D.C., District of Columbia, United States
Washington D.C., District of Columbia, United States
Jacksonville, Florida, United States
Orlando, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, United States
Emory
Atlanta, Georgia, United States
Medical College of Georgia
Augusta, Georgia, United States
Kootenai Cancer Center
Post Falls, Idaho, United States
Chicago, Illinois, United States
Park Ridge, Illinois, United States
Indiana University Simon Cancer Center
Indiannapolis, Indiana, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
Kansas City Cancer Center
Overland Park, Kansas, United States
New Orleans, Louisiana, United States
LSU Health Sciences Center, Feist-Weiller Cancer Center
Shreveport, Louisiana, United States
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
St.Louis University
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Las Vegas, Nevada, United States
Hackensack, New Jersey, United States
Morristown, New Jersey, United States
Saint Barnabas
West Orange, New Jersey, United States
Albuquerque, New Mexico, United States
Mount Sinai School of Medicine
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
The Bronx, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Durham, North Carolina, United States
Raleigh, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Summa Health System
Akron, Ohio, United States
UC Cancer Institute
Cinncinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Medical Center
Columbus, Ohio, United States
Cancer Care Associates
Tulsa, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
Bethelehem, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Pennsylvania Oncology/Hematology Associates
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Providence, Rhode Island, United States
Charleston, South Carolina, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Texas Oncology
Bedford, Texas, United States
Texas Oncology - Medical City Dallas
Dallas, Texas, United States
Cancer Therapy and Research Center
San Antonio, Texas, United States
Utah Cancer Specialists
Salt Lake City, Utah, United States
Burlington, Vermont, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
University of Washington/Seattle Cancer Care Alliance
Seattle, Washington, United States
Bellin Cancer Center
Green Bay, Wisconsin, United States
University of Wisconsin
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Ciudad de Buenos Aires, , Argentina
Córdoba, , Argentina
Ramos Mejía, , Argentina
Instituto CAICI
Rosario, , Argentina
Sante Fe, , Argentina
North Adelaide Oncology
Adelaide, , Australia
Royal Adelaide Hospital
Adelaide, , Australia
Camperdown, , Australia
East Melbourne, , Australia
The Canberra Hospital
Garran, , Australia
Garran, , Australia
Kurralta Park, , Australia
Nedlands, , Australia
Prince of Wales Hospital
Randwick, , Australia
Princess Alexandra Hospital
Woolloongabba, , Australia
Antwerp, , Belgium
Brussels, , Belgium
Leuven, , Belgium
Liège, , Belgium
Institution name: Hospital de Câncer de Barretos - Fundação PIOXII
Barretos, , Brazil
Belo Horizonte, , Brazil
Santa Casa da Misericórdia de Curitiba
Curitiba, , Brazil
Florianópolis, , Brazil
Jaú, , Brazil
Hospital da Cidade de Passo Fundo
Passo Fundo, , Brazil
Hospital das Clínicas de Porto Alegre
Porto Alegre, , Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, , Brazil
Centro de Oncologia da Bahia
Salvador, , Brazil
São Paulo, , Brazil
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
McGill University
Montreal, Quebec, Canada
Santiago, , Chile
Instituto Clínico Oncológico del Sur
Temuco, , Chile
Viña del Mar, , Chile
Bogotá, , Colombia
Medellín, , Colombia
Montería, , Colombia
Angers, , France
Bordeaux, , France
Institut Paoli Calmettes
Marseille, , France
Marseille, , France
Montpellier, , France
Nice, , France
Paris, , France
Toulouse, , France
Villejuif, , France
HELIOS Klinikum Berlin Buch
Bad Sarrow, , Germany
Universitätsklinikum Köln
Cologne, , Germany
Hanover, , Germany
Mannheim, , Germany
Tuebingen University Hospital
Tübingen, , Germany
Guatemala City, , Guatemala
Jaipur, , India
Mumbai, , India
Nashik, , India
Pune, , India
Secunderabad, , India
Haifa, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Jerusalem, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Tel Aviv, , Israel
Candiolo, , Italy
Humanitas Cancer Center
Rozzana, , Italy
Ospedale Gradenigo Oncology
Torino, , Italy
Centro Hemato Oncologico Paitilla
Panama City, , Panama
Medical and Research Center
Panama City, , Panama
Wojewodzkie Centrum Onkologii
Gdansk, , Poland
Gilwice, , Poland
Centrum Onkologii Instytut
Warsaw, , Poland
Bucharest, , Romania
Cluj-Napoca, , Romania
Craiova, , Romania
Moscow, , Russia
Obninsk, , Russia
Saint Petersburg, , Russia
Yaroslavl, , Russia
Singapore, , Singapore
Badalona, , Spain
Madrid, , Spain
Hospital Universitario Puerta de Hierro
Majadahonda, , Spain
Valencia, , Spain
The Royal Marsden NHS Foundation Trust Sarcoma
London, , United Kingdom
Christie Hospital NHS Foundation Trust
Manchester, , United Kingdom
Countries
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References
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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.
Other Identifiers
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IPM3001
Identifier Type: -
Identifier Source: org_study_id
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