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

July 17, 2013 updated by: Alaunos Therapeutics

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.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

447

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad de Buenos Aires, Argentina
      • Cordoba, Argentina
      • Ramos Mejia, Argentina
      • Rosario, Argentina
        • Instituto Caici
      • Sante Fe, Argentina
  • Australia
      • Adelaide, Australia
        • Royal Adelaide Hospital
      • Adelaide, Australia, SA 5006
        • North Adelaide Oncology
      • Camperdown, Australia
      • East Melbourne, Australia
      • Garran, Australia
        • The Canberra Hospital
      • Garran, Australia
      • Kurralta Park, Australia
      • Nedlands, Australia
      • Randwick, Australia, NSW 2031
        • Prince of Wales Hospital
      • Woolloongabba, Australia, 4102
        • Princess Alexandra Hospital
  • Belgium
      • Antwerp, Belgium
      • Bruxelles, Belgium
      • Leuven, Belgium
      • Liege, Belgium
  • Brazil
      • Barretos, Brazil
        • Institution name: Hospital de Câncer de Barretos - Fundação PIOXII
      • Belo Horizonte, Brazil
      • Curitiba, Brazil
        • Santa Casa da Misericórdia de Curitiba
      • Florianopolis, Brazil
      • Jau, Brazil
      • Passo Fundo, Brazil
        • Hospital da cidade de Passo Fundo
      • Porto Alegre, Brazil
        • Hospital das Clinicas de Porto Alegre
      • Porto Alegre, Brazil
        • Irmandade da Santa Casa de Misericordia de Porto Alegre
      • Salvador, Brazil
        • Centro de Oncologia da Bahia
      • Sao Paulo, Brazil
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
      • Edmonton, Alberta, Canada
        • Cross Cancer Institute
    • Ontario
      • Toronto, Ontario, Canada
        • Mount Sinai Hospital
    • Quebec
      • Montreal, Quebec, Canada
        • McGill University
      • Montreal, Quebec, Canada
        • Jewish General Hospital
  • Chile
      • Santiago, Chile
      • Temuco, Chile
        • Instituto Clinico Oncologico del Sur
      • Vina del Mar, Chile
  • Colombia
      • Bogota, Colombia
      • Medellin, Colombia
      • Monteria, Colombia
  • France
      • Angers, France
      • Bordeaux, France
      • Marseille, France
      • Marseilles, France
        • Institut Paoli Calmettes
      • Montpellier, France
      • Nice, France
      • Paris, France
      • Toulouse, France
      • Villejuif, France
  • Germany
      • Bad Sarrow, Germany
        • HELIOS Klinikum Berlin Buch
      • Hannover, Germany
      • Koln, Germany
        • Universitatsklinikum Koln
      • Mannheim, Germany
      • Tuebingen, Germany
        • Tuebingen University Hospital
  • Guatemala
      • Guatemala, Guatemala
  • India
      • Jaipur, India
      • Mumbai, India
      • Nasik, India
      • Pune, India
      • Secunderabad, India
  • Israel
      • Haifa, Israel
      • Jerusalem, Israel
      • Jerusalem, Israel
        • Shaare Zedek Medical Center
      • Petach Tikva, Israel
      • Ramat Gan, Israel
      • Ramat-Gan, Israel
      • Tel Aviv, Israel
  • Italy
      • Candiolo, Italy
      • Rozzana, Italy
        • Humanitas Cancer Center
      • Torino, Italy
        • Ospedale Gradenigo Oncology
  • Panama
      • Panama, Panama
        • Centro Hemato Oncologico Paitilla
      • Panama, Panama
        • Medical and Research Center
  • Poland
      • Gdansk, Poland
        • Wojewodzkie Centrum Onkologii
      • Gilwice, Poland
      • Warszawa, Poland
        • Centrum Onkologii Instytut
  • Romania
      • Bucharest, Romania
      • Cluj Napoca, Romania
      • Craiova, Romania
  • Russian Federation
      • Moscow, Russian Federation
      • Obninsk, Russian Federation
      • St. Petersburg, Russian Federation
      • Yaroslavl, Russian Federation
  • Singapore
      • Singapore, Singapore
  • Spain
      • Badalona, Spain
      • Madrid, Spain
      • Majadahonda, Spain
        • Hospital Universitario Puerta de Hierro
      • Valencia, Spain
  • United Kingdom
      • London, United Kingdom, SW3 6JJ
        • The Royal Marsden NHS Foundation Trust Sarcoma
      • Manchester, United Kingdom
        • Christie Hospital NHS Foundation Trust
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
        • Arizona Oncology Associates
      • Scottsdale, Arizona, United States
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Los Angeles, California, United States
      • Los Angeles, California, United States
        • University of California, Los Angeles
      • Orange, California, United States
        • University of California, Irvine
      • Pomona, California, United States
      • Santa Monica, California, United States
        • Sarcoma Oncology Center
    • Colorado
      • Aurora, Colorado, United States
        • University of Colorado Cancer Center
      • Denver, Colorado, United States
        • Rocky Mountain Cancer Centers
    • Delaware
      • Newark, Delaware, United States
        • Medical Oncology Hematology Consultants
    • District of Columbia
      • Washington, District of Columbia, United States
      • Washington, District of Columbia, United States
        • Medstar Research Institute
    • Florida
      • Jacksonville, Florida, United States
      • Orlando, Florida, United States
      • Tampa, Florida, United States
        • Moffitt Cancer Center
      • West Palm Beach, Florida, United States
        • Palm Beach Cancer Institute
    • Georgia
      • Atlanta, Georgia, United States
        • Emory
      • Augusta, Georgia, United States
        • Medical College of Georgia
    • Idaho
      • Post Falls, Idaho, United States, 83854
        • Kootenai Cancer Center
    • Illinois
      • Chicago, Illinois, United States
      • Park Ridge, Illinois, United States
    • Indiana
      • Indiannapolis, Indiana, United States
        • Indiana University Simon Cancer Center
    • Iowa
      • Iowa City, Iowa, United States
        • University of Iowa Hospital and Clinics
    • Kansas
      • Overland Park, Kansas, United States
        • Kansas City Cancer Center
    • Louisiana
      • New Orleans, Louisiana, United States
      • Shreveport, Louisiana, United States
        • LSU Health Sciences Center, Feist-Weiller Cancer Center
    • Maryland
      • Baltimore, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
        • Dana-Farber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, United States
    • Minnesota
      • Rochester, Minnesota, United States
        • Mayo Clinic
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • St.Louis University
      • St. Louis, Missouri, United States
        • Washington University School of Medicine
    • Nevada
      • Las Vegas, Nevada, United States
    • New Jersey
      • Hackensack, New Jersey, United States
      • Morristown, New Jersey, United States
      • West Orange, New Jersey, United States
        • Saint Barnabas
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Bronx, New York, United States
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
      • New York, New York, United States
        • Columbia University Medical Center
      • Rochester, New York, United States
        • University of Rochester
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • University of North Carolina
      • Durham, North Carolina, United States
      • Raleigh, North Carolina, United States
      • Winston-Salem, North Carolina, United States
        • Wake Forest University Health Sciences
    • Ohio
      • Akron, Ohio, United States
        • Summa Health System
      • Cinncinnati, Ohio, United States
        • UC Cancer Institute
      • Cleveland, Ohio, United States
        • Cleveland Clinic
      • Columbus, Ohio, United States
        • The Ohio State University Medical Center
    • Oklahoma
      • Tulsa, Oklahoma, United States
        • Cancer Care Associates
    • Oregon
      • Portland, Oregon, United States
        • Oregon Health and Science University
    • Pennsylvania
      • Bethelehem, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States
        • Pennsylvania Oncology/Hematology Associates
      • Pittsburg, Pennsylvania, United States, 15232
        • University of Pittsburgh
    • Rhode Island
      • Providence, Rhode Island, United States
    • South Carolina
      • Charleston, South Carolina, United States
      • Greenville, South Carolina, United States
        • Cancer Centers of the Carolinas
    • Tennessee
      • Memphis, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Bedford, Texas, United States
        • Texas Oncology
      • Dallas, Texas, United States
        • Texas Oncology - Medical City Dallas
      • San Antonio, Texas, United States, 8229
        • Cancer Therapy and Research Center
    • Utah
      • Salt Lake City, Utah, United States
        • Utah Cancer Specialists
    • Vermont
      • Burlington, Vermont, United States
    • Virginia
      • Fairfax, Virginia, United States
        • Virginia Cancer Specialists
    • Washington
      • Seattle, Washington, United States
        • University of Washington/Seattle Cancer Care Alliance
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54313
        • Bellin Cancer Center
      • Madison, Wisconsin, United States
        • University of Wisconsin
      • Milwaukee, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: doxorubicin plus palifosfamide-tris
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.
Active Comparator: doxorubicin plus placebo
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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

Outcome Measure
Time Frame
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
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
Time Frame: 22 weeks
22 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alaunos Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

July 21, 2010

First Submitted That Met QC Criteria

July 21, 2010

First Posted (Estimate)

July 23, 2010

Study Record Updates

Last Update Posted (Estimate)

July 18, 2013

Last Update Submitted That Met QC Criteria

July 17, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPM3001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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