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

NCT01168791 | Completed Phase 3 DMC

• 1 other identifier: IPM3001
• Study Type: interventional
• Target: 447
• Locations: 21 countries
• Sites: 161

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).

Conditions

Soft Tissue Sarcoma

Keywords

Metastatic; Front line

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival followed by Overall Survival

  assessed every 6 weeks for 22 weeks, then 8 weeks for 6 months/until progression, then every 12 weeks until then death

Secondary Outcomes (2)

• Quality of Life, as assessed by EORTC QLQ-C30 and EQ-5D questionnaires

  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

  22 weeks

Study Arms (2)

doxorubicin plus palifosfamide-tris

EXPERIMENTAL

Drug: doxorubicin in combination with palifosfamide-tris

doxorubicin plus placebo

ACTIVE COMPARATOR

Drug: doxorubicin in combination with placebo

Interventions

doxorubicin in combination with palifosfamide-tris DRUG

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 palifosfamide-tris

doxorubicin in combination with placebo DRUG

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.

doxorubicin plus placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alaunos Therapeutics: lead

Study Sites (161)

Unknown Facility

Birmingham, Alabama, United States

Location

Arizona Oncology Associates

Phoenix, Arizona, United States

Location

Unknown Facility

Scottsdale, Arizona, United States

Location

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

University of California, Los Angeles

Los Angeles, California, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

University of California, Irvine

Orange, California, United States

Location

Unknown Facility

Pomona, California, United States

Location

Sarcoma Oncology Center

Santa Monica, California, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, United States

Location

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Location

Medical Oncology Hematology Consultants

Newark, Delaware, United States

Location

MedStar Research Institute

Washington D.C., District of Columbia, United States

Location

Unknown Facility

Washington D.C., District of Columbia, United States

Location

Unknown Facility

Jacksonville, Florida, United States

Location

Unknown Facility

Orlando, Florida, United States

Location

Moffitt Cancer Center

Tampa, Florida, United States

Location

Palm Beach Cancer Institute

West Palm Beach, Florida, United States

Location

Emory

Atlanta, Georgia, United States

Location

Medical College of Georgia

Augusta, Georgia, United States

Location

Kootenai Cancer Center

Post Falls, Idaho, 83854, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Park Ridge, Illinois, United States

Location

Indiana University Simon Cancer Center

Indiannapolis, Indiana, United States

Location

University of Iowa Hospital and Clinics

Iowa City, Iowa, United States

Location

Kansas City Cancer Center

Overland Park, Kansas, United States

Location

Unknown Facility

New Orleans, Louisiana, United States

Location

LSU Health Sciences Center, Feist-Weiller Cancer Center

Shreveport, Louisiana, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Location

Unknown Facility

Ann Arbor, Michigan, United States

Location

Mayo Clinic

Rochester, Minnesota, United States

Location

St.Louis University

St Louis, Missouri, 63110, United States

Location

Washington University School of Medicine

St Louis, Missouri, United States

Location

Unknown Facility

Las Vegas, Nevada, United States

Location

Unknown Facility

Hackensack, New Jersey, United States

Location

Unknown Facility

Morristown, New Jersey, United States

Location

Saint Barnabas

West Orange, New Jersey, United States

Location

Unknown Facility

Albuquerque, New Mexico, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Columbia University Medical Center

New York, New York, United States

Location

University of Rochester

Rochester, New York, United States

Location

Unknown Facility

The Bronx, New York, United States

Location

University of North Carolina

Chapel Hill, North Carolina, United States

Location

Unknown Facility

Durham, North Carolina, United States

Location

Unknown Facility

Raleigh, North Carolina, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Location

Summa Health System

Akron, Ohio, United States

Location

UC Cancer Institute

Cinncinnati, Ohio, United States

Location

Cleveland Clinic

Cleveland, Ohio, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, United States

Location

Cancer Care Associates

Tulsa, Oklahoma, United States

Location

Oregon Health and Science University

Portland, Oregon, United States

Location

Unknown Facility

Bethelehem, Pennsylvania, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Location

Pennsylvania Oncology/Hematology Associates

Philadelphia, Pennsylvania, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15232, United States

Location

Unknown Facility

Providence, Rhode Island, United States

Location

Unknown Facility

Charleston, South Carolina, United States

Location

Cancer Centers of the Carolinas

Greenville, South Carolina, United States

Location

Unknown Facility

Memphis, Tennessee, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Texas Oncology

Bedford, Texas, United States

Location

Texas Oncology - Medical City Dallas

Dallas, Texas, United States

Location

Cancer Therapy and Research Center

San Antonio, Texas, 8229, United States

Location

Utah Cancer Specialists

Salt Lake City, Utah, United States

Location

Unknown Facility

Burlington, Vermont, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, United States

Location

University of Washington/Seattle Cancer Care Alliance

Seattle, Washington, United States

Location

Bellin Cancer Center

Green Bay, Wisconsin, 54313, United States

Location

University of Wisconsin

Madison, Wisconsin, United States

Location

Unknown Facility

Milwaukee, Wisconsin, United States

Location

Unknown Facility

Ciudad de Buenos Aires, Argentina

Location

Unknown Facility

Córdoba, Argentina

Location

Unknown Facility

Ramos Mejía, Argentina

Location

Instituto CAICI

Rosario, Argentina

Location

Unknown Facility

Sante Fe, Argentina

Location

North Adelaide Oncology

Adelaide, SA 5006, Australia

Location

Royal Adelaide Hospital

Adelaide, Australia

Location

Unknown Facility

Camperdown, Australia

Location

Unknown Facility

East Melbourne, Australia

Location

The Canberra Hospital

Garran, Australia

Location

Unknown Facility

Garran, Australia

Location

Unknown Facility

Kurralta Park, Australia

Location

Unknown Facility

Nedlands, Australia

Location

Prince of Wales Hospital

Randwick, NSW 2031, Australia

Location

Princess Alexandra Hospital

Woolloongabba, 4102, Australia

Location

Unknown Facility

Antwerp, Belgium

Location

Unknown Facility

Brussels, Belgium

Location

Unknown Facility

Leuven, Belgium

Location

Unknown Facility

Liège, Belgium

Location

Institution name: Hospital de Câncer de Barretos - Fundação PIOXII

Barretos, Brazil

Location

Unknown Facility

Belo Horizonte, Brazil

Location

Santa Casa da Misericórdia de Curitiba

Curitiba, Brazil

Location

Unknown Facility

Florianópolis, Brazil

Location

Unknown Facility

Jaú, Brazil

Location

Hospital da Cidade de Passo Fundo

Passo Fundo, Brazil

Location

Hospital das Clínicas de Porto Alegre

Porto Alegre, Brazil

Location

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Brazil

Location

Centro de Oncologia da Bahia

Salvador, Brazil

Location

Unknown Facility

São Paulo, Brazil

Location

Unknown Facility

Calgary, Alberta, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, Canada

Location

Jewish General Hospital

Montreal, Quebec, Canada

Location

McGill University

Montreal, Quebec, Canada

Location

Unknown Facility

Santiago, Chile

Location

Instituto Clínico Oncológico del Sur

Temuco, Chile

Location

Unknown Facility

Viña del Mar, Chile

Location

Unknown Facility

Bogotá, Colombia

Location

Unknown Facility

Medellín, Colombia

Location

Unknown Facility

Montería, Colombia

Location

Unknown Facility

Angers, France

Location

Unknown Facility

Bordeaux, France

Location

Institut Paoli Calmettes

Marseille, France

Location

Unknown Facility

Marseille, France

Location

Unknown Facility

Montpellier, France

Location

Unknown Facility

Nice, France

Location

Unknown Facility

Paris, France

Location

Unknown Facility

Toulouse, France

Location

Unknown Facility

Villejuif, France

Location

HELIOS Klinikum Berlin Buch

Bad Sarrow, Germany

Location

Universitätsklinikum Köln

Cologne, Germany

Location

Unknown Facility

Hanover, Germany

Location

Unknown Facility

Mannheim, Germany

Location

Tuebingen University Hospital

Tübingen, Germany

Location

Unknown Facility

Guatemala City, Guatemala

Location

Unknown Facility

Jaipur, India

Location

Unknown Facility

Mumbai, India

Location

Unknown Facility

Nashik, India

Location

Unknown Facility

Pune, India

Location

Unknown Facility

Secunderabad, India

Location

Unknown Facility

Haifa, Israel

Location

Shaare Zedek Medical Center

Jerusalem, Israel

Location

Unknown Facility

Jerusalem, Israel

Location

Unknown Facility

Petah Tikva, Israel

Location

Unknown Facility

Ramat Gan, Israel

Location

Unknown Facility

Tel Aviv, Israel

Location

Unknown Facility

Candiolo, Italy

Location

Humanitas Cancer Center

Rozzana, Italy

Location

Ospedale Gradenigo Oncology

Torino, Italy

Location

Centro Hemato Oncologico Paitilla

Panama City, Panama

Location

Medical and Research Center

Panama City, Panama

Location

Wojewodzkie Centrum Onkologii

Gdansk, Poland

Location

Unknown Facility

Gilwice, Poland

Location

Centrum Onkologii Instytut

Warsaw, Poland

Location

Unknown Facility

Bucharest, Romania

Location

Unknown Facility

Cluj-Napoca, Romania

Location

Unknown Facility

Craiova, Romania

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Obninsk, Russia

Location

Unknown Facility

Saint Petersburg, Russia

Location

Unknown Facility

Yaroslavl, Russia

Location

Unknown Facility

Singapore, Singapore

Location

Unknown Facility

Badalona, Spain

Location

Unknown Facility

Madrid, Spain

Location

Hospital Universitario Puerta de Hierro

Majadahonda, Spain

Location

Unknown Facility

Valencia, Spain

Location

The Royal Marsden NHS Foundation Trust Sarcoma

London, SW3 6JJ, United Kingdom

Location

Christie Hospital NHS Foundation Trust

Manchester, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 27621408 DERIVED

MeSH Terms

Conditions

Sarcoma; Neoplasm Metastasis

Interventions

Doxorubicin; isophosphamide mustard

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2010
• First Posted: July 23, 2010
• Study Start: July 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: July 18, 2013

Record last verified: 2013-07

Locations

AU (10); RO (3); AR (5); IN (5); PL (3); DE (5); US (73); FR (9); SG (1); IL (6); ES (4); GB (2); CA (5); GU (1); BE (4); BR (10); PA (2); CL (3); RU (4); CO (3); IT (3)