NCT00064324

Perifosine in Treating Patients With Advanced Soft Tissue Sarcoma

A Phase II Study of Perifosine in Soft Tissue Sarcoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase II trial to study the effectiveness of perifosine in treating patients who have advanced soft tissue sarcoma. Drugs used in chemotherapy such as perifosine use different ways to stop tumor cells from dividing so they stop growing or die.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the 6-month progression-free rate in patients treated with perifosine and having advanced soft tissue sarcoma. SECONDARY OBJECTIVES: I. To evaluate survival and time to progression. II. To evaluate objective tumor response status and duration. III. To evaluate adverse event rates. IV. To evaluate patterns of treatment failure. V. To evaluate pharmacokinetics. OUTLINE: This is a multicenter study. Patients receive a loading dose of oral perifosine every 6 hours for a total of 4 doses on day 1 and once daily on days 2-28 of course 1 only. For all subsequent courses, patients receive oral perifosine once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 5 years. PROJECTED ACCRUAL: A total of 17-46 patients will be accrued for this study within 9-12 months.

Conditions

• Recurrent Adult Soft Tissue Sarcoma
• Stage III Adult Soft Tissue Sarcoma
• Stage IV Adult Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	perifosine	Given orally
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	pharmacological study	Correlative studies

Timeline

• Start date: 2003-06-01
• Primary completion: 2005-11-01
• First posted: 2003-07-09
• Last updated: 2013-06-04

Locations

1 site across 1 country: United States