Clinical Trial: A Trial of Perifosine in Patients With Chemo-Insensitive Sarcomas

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Sarcoma Alliance for Research Through Collaboration (SARC) Multicenter Trial: A Phase II Trial of Perifosine in Patients With Chemo-Insensitive Sarcomas

Brief Summary:

This is a phase II study of perifosine in patients with chondrosarcomas, alveolar soft part sarcomas and extra-skeletal myxoid chondrosarcomas. Patients will receive perifosine 100 mg orally qhs with food until disease progression. The goals of this study include:

  • In this study a daily dose of perifosine previously determined to be relatively non-toxic will be evaluated in patients with chondrosarcomas, alveolar soft part sarcomas and extra-skeletal myxoid chondrosarcomas.
  • Response to therapy will be based on regression of measurable disease according to Choi criteria. Time to progression and duration of stable disease will be measured as secondary endpoints of the study.

Detailed Summary:

This is a phase II study of perifosine in patients with chondrosarcomas, alveolar soft part sarcomas and extra-skeletal myxoid chondrosarcomas. Patients will receive perifosine 100 mg orally qhs with food until disease progression.

Perifosine is available in 50 mg tablets. Patients will take two perifosine 50 mg tablets orally once a day at bedtime with food. Administering the drug qhs has been shown to decrease gastrointestinal toxicity in some patients. Patients may need anti-emetics and/or anti-diarrheals. All patients may continue therapy unless disease progression is documented on two occasions at least 4 weeks apart. Patients who experience toxicity may continue on treatment with doses delayed or reduced. Evaluation of all lesions for progression or response will be made at 3-month intervals.

STUDY KEY POINTS

  • Treatment will be administered on an outpatient basis in 28-day cycles.
  • Growth factors should not be needed, however, use by patients on this trial is NOT prohibited.
  • A favorable outcome will be defined as a complete or partial response according to the Choi criteria or stable disease by the Choi criteria for 6 months or longer.

Sponsor: AEterna Zentaris

Current Primary Outcome: Response Rate [ Time Frame: 6 months ]

Original Primary Outcome: Response Rate

Current Secondary Outcome:

  • Time to progression [ Time Frame: 6 months ]
  • Stable disease of six months or greater [ Time Frame: >= 6 months ]


Original Secondary Outcome:

  • Time to progression
  • Stable disease of six months or greater


Information By: AEterna Zentaris

Dates:
Date Received: November 17, 2006
Date Started: November 2006
Date Completion:
Last Updated: March 4, 2013
Last Verified: February 2012