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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ziopharm
ClinicalTrials.gov Identifier:
NCT01168791
First received: July 21, 2010
Last updated: July 17, 2013
Last verified: July 2013
  Purpose

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).


Condition Intervention Phase
Soft Tissue Sarcoma
Drug: doxorubicin in combination with palifosfamide-tris
Drug: doxorubicin in combination with placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Ziopharm:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Safety and Tolerability as evaluated using CTCAE v 4.0 [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]

Enrollment: 447
Study Start Date: July 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01168791

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

No publications provided

Responsible Party: Ziopharm
ClinicalTrials.gov Identifier: NCT01168791     History of Changes
Other Study ID Numbers: IPM3001
Study First Received: July 21, 2010
Last Updated: July 17, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Romania: National Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Italy: The Italian Medicines Agency
Germany: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Belgium: Federal Agency for Medicinal Products and Health Products
Israel: Ministry of Health
Argentina: Ministry of Health
Brazil: Ministry of Health
Chile: Instituto de Salud Pública de Chile
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Guatemala: Ministry of Public Health and Social Assistance
Panama: Ministry of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
Korea: Food and Drug Administration

Keywords provided by Ziopharm:
Metastatic
Front line

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Doxorubicin
Isophosphamide mustard
Ifosfamide
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014