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

Primary Purpose

Soft Tissue Sarcoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
doxorubicin in combination with palifosfamide-tris
doxorubicin in combination with placebo
Sponsored by
Alaunos Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Soft Tissue Sarcoma focused on measuring Metastatic, Front line

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arizona Oncology Associates
  • Arizona Cancer Center
  • University of Arkansas for Medical Sciences
  • University of California, Los Angeles
  • University of California, Irvine
  • Sarcoma Oncology Center
  • University of Colorado Cancer Center
  • Rocky Mountain Cancer Centers
  • Medical Oncology Hematology Consultants
  • MedStar Research Institute
  • Moffitt Cancer Center
  • Palm Beach Cancer Institute
  • Emory
  • Medical College of Georgia
  • Kootenai Cancer Center
  • Indiana University Simon Cancer Center
  • University of Iowa Hospital and Clinics
  • Kansas City Cancer Center
  • LSU Health Sciences Center, Feist-Weiller Cancer Center
  • Dana-Farber Cancer Institute
  • Mayo Clinic
  • St.Louis University
  • Washington University School of Medicine
  • Saint Barnabas
  • Mount Sinai School of Medicine
  • Columbia University Medical Center
  • University of Rochester
  • University of North Carolina
  • Wake Forest University Health Sciences
  • Summa Health System
  • UC Cancer Institute
  • Cleveland Clinic
  • The Ohio State University Medical Center
  • Cancer Care Associates
  • Oregon Health and Science University
  • Fox Chase Cancer Center
  • Pennsylvania Oncology/Hematology Associates
  • University of Pittsburgh
  • Cancer Centers of the Carolinas
  • Texas Oncology
  • Texas Oncology - Medical City Dallas
  • Cancer Therapy and Research Center
  • Utah Cancer Specialists
  • Virginia Cancer Specialists
  • University of Washington/Seattle Cancer Care Alliance
  • Bellin Cancer Center
  • University of Wisconsin
  • Instituto CAICI
  • North Adelaide Oncology
  • Royal Adelaide Hospital
  • The Canberra Hospital
  • Prince of Wales Hospital
  • Princess Alexandra Hospital
  • Institution name: Hospital de Câncer de Barretos - Fundação PIOXII
  • Santa Casa da Misericórdia de Curitiba
  • Hospital da Cidade de Passo Fundo
  • Hospital das Clínicas de Porto Alegre
  • Irmandade da Santa Casa de Misericórdia de Porto Alegre
  • Centro de Oncologia da Bahia
  • Cross Cancer Institute
  • Mount Sinai Hospital
  • Jewish General Hospital
  • McGill University
  • Instituto Clínico Oncológico del Sur
  • Institut Paoli Calmettes
  • HELIOS Klinikum Berlin Buch
  • Universitätsklinikum Köln
  • Tuebingen University Hospital
  • Shaare Zedek Medical Center
  • Humanitas Cancer Center
  • Ospedale Gradenigo Oncology
  • Centro Hemato Oncologico Paitilla
  • Medical and Research Center
  • Wojewodzkie Centrum Onkologii
  • Centrum Onkologii Instytut
  • Hospital Universitario Puerta de Hierro
  • The Royal Marsden NHS Foundation Trust Sarcoma
  • Christie Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

doxorubicin plus palifosfamide-tris

doxorubicin plus placebo

Arm Description

Outcomes

Primary Outcome Measures

Progression Free Survival followed by Overall Survival

Secondary Outcome Measures

Quality of Life, as assessed by EORTC QLQ-C30 and EQ-5D questionnaires
Safety and Tolerability as evaluated using CTCAE v 4.0

Full Information

First Posted
July 21, 2010
Last Updated
July 17, 2013
Sponsor
Alaunos Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01168791
Brief Title
Study of Palifosfamide-tris in Combination With Doxorubicin in Patients With Front-line Metastatic Soft Tissue Sarcoma
Acronym
PICASSO III
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

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alaunos Therapeutics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Sarcoma
Keywords
Metastatic, Front line

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
447 (Actual)

8. Arms, Groups, and Interventions

Arm Title
doxorubicin plus palifosfamide-tris
Arm Type
Experimental
Arm Title
doxorubicin plus placebo
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
doxorubicin in combination with palifosfamide-tris
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
doxorubicin in combination with placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression Free Survival followed by Overall Survival
Time Frame
assessed every 6 weeks for 22 weeks, then 8 weeks for 6 months/until progression, then every 12 weeks until then death
Secondary Outcome Measure Information:
Title
Quality of Life, as assessed by EORTC QLQ-C30 and EQ-5D questionnaires
Time Frame
assessed every 6 weeks for 22 weeks, then 8 weeks for 6 months, then every 12 weeks until death
Title
Safety and Tolerability as evaluated using CTCAE v 4.0
Time Frame
22 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Arizona Oncology Associates
City
Phoenix
State/Province
Arizona
Country
United States
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
Facility Name
University of California, Irvine
City
Orange
State/Province
California
Country
United States
City
Pomona
State/Province
California
Country
United States
Facility Name
Sarcoma Oncology Center
City
Santa Monica
State/Province
California
Country
United States
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Medical Oncology Hematology Consultants
City
Newark
State/Province
Delaware
Country
United States
Facility Name
MedStar Research Institute
City
Washington
State/Province
District of Columbia
Country
United States
City
Washington
State/Province
District of Columbia
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Palm Beach Cancer Institute
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
Emory
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Medical College of Georgia
City
Augusta
State/Province
Georgia
Country
United States
Facility Name
Kootenai Cancer Center
City
Post Falls
State/Province
Idaho
ZIP/Postal Code
83854
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Park Ridge
State/Province
Illinois
Country
United States
Facility Name
Indiana University Simon Cancer Center
City
Indiannapolis
State/Province
Indiana
Country
United States
Facility Name
University of Iowa Hospital and Clinics
City
Iowa City
State/Province
Iowa
Country
United States
Facility Name
Kansas City Cancer Center
City
Overland Park
State/Province
Kansas
Country
United States
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
LSU Health Sciences Center, Feist-Weiller Cancer Center
City
Shreveport
State/Province
Louisiana
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
Country
United States
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
Country
United States
Facility Name
St.Louis University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Hackensack
State/Province
New Jersey
Country
United States
City
Morristown
State/Province
New Jersey
Country
United States
Facility Name
Saint Barnabas
City
West Orange
State/Province
New Jersey
Country
United States
City
Albuquerque
State/Province
New Mexico
Country
United States
City
Bronx
State/Province
New York
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
Country
United States
City
Durham
State/Province
North Carolina
Country
United States
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Summa Health System
City
Akron
State/Province
Ohio
Country
United States
Facility Name
UC Cancer Institute
City
Cinncinnati
State/Province
Ohio
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Cancer Care Associates
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
Country
United States
City
Bethelehem
State/Province
Pennsylvania
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Pennsylvania Oncology/Hematology Associates
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburg
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
City
Providence
State/Province
Rhode Island
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Cancer Centers of the Carolinas
City
Greenville
State/Province
South Carolina
Country
United States
City
Memphis
State/Province
Tennessee
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Texas Oncology
City
Bedford
State/Province
Texas
Country
United States
Facility Name
Texas Oncology - Medical City Dallas
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Cancer Therapy and Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
8229
Country
United States
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
Country
United States
City
Burlington
State/Province
Vermont
Country
United States
Facility Name
Virginia Cancer Specialists
City
Fairfax
State/Province
Virginia
Country
United States
Facility Name
University of Washington/Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Bellin Cancer Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54313
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
Country
United States
City
Milwaukee
State/Province
Wisconsin
Country
United States
City
Ciudad de Buenos Aires
Country
Argentina
City
Cordoba
Country
Argentina
City
Ramos Mejia
Country
Argentina
Facility Name
Instituto CAICI
City
Rosario
Country
Argentina
City
Sante Fe
Country
Argentina
Facility Name
North Adelaide Oncology
City
Adelaide
ZIP/Postal Code
SA 5006
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
Country
Australia
City
Camperdown
Country
Australia
City
East Melbourne
Country
Australia
Facility Name
The Canberra Hospital
City
Garran
Country
Australia
City
Garran
Country
Australia
City
Kurralta Park
Country
Australia
City
Nedlands
Country
Australia
Facility Name
Prince of Wales Hospital
City
Randwick
ZIP/Postal Code
NSW 2031
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
ZIP/Postal Code
4102
Country
Australia
City
Antwerp
Country
Belgium
City
Bruxelles
Country
Belgium
City
Leuven
Country
Belgium
City
Liege
Country
Belgium
Facility Name
Institution name: Hospital de Câncer de Barretos - Fundação PIOXII
City
Barretos
Country
Brazil
City
Belo Horizonte
Country
Brazil
Facility Name
Santa Casa da Misericórdia de Curitiba
City
Curitiba
Country
Brazil
City
Florianopolis
Country
Brazil
City
Jau
Country
Brazil
Facility Name
Hospital da Cidade de Passo Fundo
City
Passo Fundo
Country
Brazil
Facility Name
Hospital das Clínicas de Porto Alegre
City
Porto Alegre
Country
Brazil
Facility Name
Irmandade da Santa Casa de Misericórdia de Porto Alegre
City
Porto Alegre
Country
Brazil
Facility Name
Centro de Oncologia da Bahia
City
Salvador
Country
Brazil
City
Sao Paulo
Country
Brazil
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
McGill University
City
Montreal
State/Province
Quebec
Country
Canada
City
Santiago
Country
Chile
Facility Name
Instituto Clínico Oncológico del Sur
City
Temuco
Country
Chile
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
Facility Name
Institut Paoli Calmettes
City
Marseilles
Country
France
City
Marseille
Country
France
City
Montpellier
Country
France
City
Nice
Country
France
City
Paris
Country
France
City
Toulouse
Country
France
City
Villejuif
Country
France
Facility Name
HELIOS Klinikum Berlin Buch
City
Bad Sarrow
Country
Germany
City
Hannover
Country
Germany
Facility Name
Universitätsklinikum Köln
City
Koln
Country
Germany
City
Mannheim
Country
Germany
Facility Name
Tuebingen University Hospital
City
Tuebingen
Country
Germany
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
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
Country
Israel
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
Facility Name
Humanitas Cancer Center
City
Rozzana
Country
Italy
Facility Name
Ospedale Gradenigo Oncology
City
Torino
Country
Italy
Facility Name
Centro Hemato Oncologico Paitilla
City
Panama
Country
Panama
Facility Name
Medical and Research Center
City
Panama
Country
Panama
Facility Name
Wojewodzkie Centrum Onkologii
City
Gdansk
Country
Poland
City
Gilwice
Country
Poland
Facility Name
Centrum Onkologii Instytut
City
Warszawa
Country
Poland
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
Facility Name
Hospital Universitario Puerta de Hierro
City
Majadahonda
Country
Spain
City
Valencia
Country
Spain
Facility Name
The Royal Marsden NHS Foundation Trust Sarcoma
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Christie Hospital NHS Foundation Trust
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27621408
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.
Results Reference
derived

Learn more about this trial

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

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