Spots Global Cancer Trial Database for Perifosine in Treating Patients With Metastatic or Locally Advanced Soft Tissue Sarcoma

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Trial Identification

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

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

Study ID: NCT00053794

Conditions

Endometrial Cancer

Sarcoma

Interventions

perifosine

Study Description

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 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.