NCT00053794

Perifosine in Treating Patients With Metastatic or Locally Advanced Soft Tissue Sarcoma

A Phase II Study Of Perifosine (D-21266) In Patients With Previously Untreated Metastatic Or Locally Advanced Soft Tissue Sarcoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

OBJECTIVES: * Determine the efficacy of perifosine, in terms of response rate and duration of response, in patients with untreated metastatic or locally advanced soft tissue sarcoma. * Determine the toxicity of this drug in these patients. * Determine the early progression rate in patients treated with this drug. OUTLINE: This is a non-randomized, non-blinded, multicenter study. Patients receive a loading dose of oral perifosine twice on day 1 and then once daily on days 2-21 for the first course. For all subsequent courses, patients receive a loading dose of oral perifosine once on day 1 and then once daily on days 2-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed for 1 month. Patients with stable or responsive disease are followed every 3 months thereafter. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 12-18 months.

Conditions

• Endometrial Cancer
• Sarcoma

Interventions

Type	Name	Description
DRUG	perifosine

Timeline

• Start date: 2003-06-09
• Primary completion: 2004-09-18
• Completion: 2008-09-22
• First posted: 2003-02-06
• Last updated: 2023-08-04

Locations

6 sites across 1 country: Canada

Regulatory

• FDA-regulated drug study