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

Soft Tissue Sarcoma Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01168791
• Other study ID #: IPM3001
• Status: Completed
• Phase: Phase 3
• First received: July 21, 2010
• Last updated: July 17, 2013
• Start date: July 2010
• Est. completion date: March 2013

Study information

• Verified date: July 2013
• Source: Ziopharm
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaUnited Kingdom: Medicines and Healthcare Products Regulatory AgencySpain: Agencia Española de Medicamentos y Productos SanitariosRomania: National Medicines AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsItaly: The Italian Medicines AgencyGermany: Ministry of HealthFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Belgium: Federal Agency for Medicinal Products and Health ProductsIsrael: Ministry of HealthArgentina: Ministry of HealthBrazil: Ministry of HealthChile: Instituto de Salud Pública de ChileColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosGuatemala: Ministry of Public Health and Social AssistancePanama: Ministry of HealthAustralia: Department of Health and Ageing Therapeutic Goods AdministrationKorea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 447
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
Argentina	Instituto CAICI	Rosario
Australia	North Adelaide Oncology	Adelaide
Australia	Royal Adelaide Hospital	Adelaide
Australia	The Canberra Hospital	Garran
Australia	Prince of Wales Hospital	Randwick
Australia	Princess Alexandra Hospital	Woolloongabba
Brazil	Institution name: Hospital de Câncer de Barretos - Fundação PIOXII	Barretos
Brazil	Santa Casa da Misericórdia de Curitiba	Curitiba
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
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Jewish General Hospital	Montreal	Quebec
Canada	McGill University	Montreal	Quebec
Canada	Mount Sinai Hospital	Toronto	Ontario
Chile	Instituto Clínico Oncológico del Sur	Temuco
France	Institut Paoli Calmettes	Marseilles
Germany	HELIOS Klinikum Berlin Buch	Bad Sarrow
Germany	Universitätsklinikum Köln	Koln
Germany	Tuebingen University Hospital	Tuebingen
Israel	Shaare Zedek Medical Center	Jerusalem
Italy	Humanitas Cancer Center	Rozzana
Italy	Ospedale Gradenigo Oncology	Torino
Panama	Centro Hemato Oncologico Paitilla	Panama
Panama	Medical and Research Center	Panama
Poland	Wojewodzkie Centrum Onkologii	Gdansk
Poland	Centrum Onkologii Instytut	Warszawa
Spain	Hospital Universitario Puerta de Hierro	Majadahonda
United Kingdom	The Royal Marsden NHS Foundation Trust Sarcoma	London
United Kingdom	Christie Hospital NHS Foundation Trust	Manchester
United States	Summa Health System	Akron	Ohio
United States	Emory	Atlanta	Georgia
United States	Medical College of Georgia	Augusta	Georgia
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	Texas Oncology	Bedford	Texas
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	University of North Carolina	Chapel Hill	North Carolina
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	Texas Oncology - Medical City Dallas	Dallas	Texas
United States	Rocky Mountain Cancer Centers	Denver	Colorado
United States	Virginia Cancer Specialists	Fairfax	Virginia
United States	Bellin Cancer Center	Green Bay	Wisconsin
United States	Cancer Centers of the Carolinas	Greenville	South Carolina
United States	Indiana University Simon Cancer Center	Indiannapolis	Indiana
United States	University of Iowa Hospital and Clinics	Iowa City	Iowa
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	University of California, Los Angeles	Los Angeles	California
United States	University of Wisconsin	Madison	Wisconsin
United States	Columbia University Medical Center	New York	New York
United States	Mount Sinai School of Medicine	New York	New York
United States	Medical Oncology Hematology Consultants	Newark	Delaware
United States	University of California, Irvine	Orange	California
United States	Kansas City Cancer Center	Overland Park	Kansas
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Pennsylvania Oncology/Hematology Associates	Philadelphia	Pennsylvania
United States	Arizona Oncology Associates	Phoenix	Arizona
United States	University of Pittsburgh	Pittsburg	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	Kootenai Cancer Center	Post Falls	Idaho
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Rochester	Rochester	New York
United States	Utah Cancer Specialists	Salt Lake City	Utah
United States	Cancer Therapy and Research Center	San Antonio	Texas
United States	Sarcoma Oncology Center	Santa Monica	California
United States	University of Washington/Seattle Cancer Care Alliance	Seattle	Washington
United States	LSU Health Sciences Center, Feist-Weiller Cancer Center	Shreveport	Louisiana
United States	St.Louis University	St. Louis	Missouri
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Moffitt Cancer Center	Tampa	Florida
United States	Arizona Cancer Center	Tucson	Arizona
United States	Cancer Care Associates	Tulsa	Oklahoma
United States	MedStar Research Institute	Washington	District of Columbia
United States	Saint Barnabas	West Orange	New Jersey
United States	Palm Beach Cancer Institute	West Palm Beach	Florida
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Ziopharm

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  Chile,  Colombia,  France,  Germany,  Guatemala,  India,  Israel,  Italy,  Panama,  Poland,  Romania,  Russian Federation,  Singapore,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Safety and Tolerability as evaluated using CTCAE v 4.0		22 weeks	No