Open Clinical Trials

A Study of Palifosfamide Tris Plus Doxorubicin Versus Doxorubicin in Unresectable or Metastatic Soft-Tissue Sarcoma (PICASSO)


Phase:
Phase II - Phase 2
Trial for Patients with:
 Soft tissue sarcoma that has failed prior treatment and/or is metastatic or unresectable
Treatment involved:
IV medication administered for 3 days every 3 weeks
Age Requirement:
18 and older
Location:
 California, Florida, Idaho, Illinois, Kansas, New Mexico, Oregon, Pennsylvania, Tennessee, Texas, Utah, Washington State, Italy, Romania
Description This is a randomized, controlled trial to evaluate the clinical benefit of palifosfamide tris administered with doxorubicin in combination, compared with single-agent doxorubicin administered in subjects diagnosed with unresectable or metastatic soft-tissue sarcoma (STS). Subjects who meet the entry criteria will be randomized into 1 of 2 arms: either to receive palifosfamide tris plus doxorubicin or treatment with single-agent doxorubicin. Subjects will be anthracyclin naïve.
Conditions:
Excluded Conditions:
  • Alveolar soft-part sarcoma
  • Chondrosarcoma
  • Dermatofibrosarcoma
  • Ewing sarcoma
  • GIST
  • Kaposi sarcoma
  • Mixed mesodermal tumor
  • Osteosarcoma
  • Radiation induced sarcomas
  • Unresectable low grade liposarcoma
Trial Start Date: August 2008
Trial End Date: June 2010 (estimated)
ClinicalTrials.gov: NCT00718484 : detailed information at ClinicalTrials.gov
Full Title: A Phase II Multicenter, Parallel Group, Randomized Study of Palifosfamide Tris Plus Doxorubicin Versus Doxorubicin in Subjects With Unresectable or Metastatic Soft-Tissue Sarcoma
This page was last updated on: March 30, 2009