Clinical Trial: Perifosine in Treating Patients With Metastatic or Locally Advanced Soft Tissue Sarcoma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase II Study Of Perifosine (D-21266) In Patients With Previously Untreated Metastatic Or Locally Advanced Soft Tissue Sarcoma
Brief 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 Summary:
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.
Sponsor: NCIC Clinical Trials Group
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Canadian Cancer Trials Group
Dates:
Date Received: February 5, 2003
Date Started: May 2003
Date Completion:
Last Updated: November 7, 2010
Last Verified: March 2010
