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

  Show 162 Study Locations
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
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Doxorubicin
Ifosfamide
Isophosphamide mustard
Liposomal doxorubicin
Alkylating Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014