Soft Tissue Sarcoma Clinical Trial
— PICASSO IIIOfficial 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.
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).
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Ziopharm |
United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, France, Germany, Guatemala, India, Israel, Italy, Panama, Poland, Romania, Russian Federation, Singapore, Spain, United Kingdom,
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 |
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