NCT00401388

A Trial of Perifosine in Patients With Chemo-Insensitive Sarcomas

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: AEterna Zentaris · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Chondrosarcomas
• Alveolar Soft Part Sarcomas
• Extra Skeletal Myxoid Chondrosarcomas

Interventions

Type	Name	Description
DRUG	Perifosine	Perifosine is available in 50 mg tablets. Patients will take two perifosine 50 mg tablets orally once a day at bedtime with food.
OTHER	Loperamide	All patients should be instructed to take loperamide at the earliest signs of diarrhea and/or abdominal cramping after beginning perifosine.
OTHER	Allopurinol	Patients with a known history of hyperuricemia and/or gout should receive prophylactic treatment with allopurinol 300 mg po daily.
OTHER	Antiemetics	Antiemetic prophylaxis will be administered at the treating investigator's discretion.

Timeline

• Start date: 2006-11-01
• Primary completion: 2011-01-01
• Completion: 2011-10-01
• First posted: 2006-11-20
• Last updated: 2018-03-07