Perifosine in Treating Patients With Metastatic or Locally Advanced Soft Tissue Sarcoma
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.
|Study Design:||Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Study Of Perifosine (D-21266) In Patients With Previously Untreated Metastatic Or Locally Advanced Soft Tissue Sarcoma|
|Study Start Date:||May 2003|
|Study Completion Date:||September 2008|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00053794
|Tom Baker Cancer Center - Calgary|
|Calgary, Alberta, Canada, T2N 4N2|
|Canada, British Columbia|
|British Columbia Cancer Agency - Vancouver Island Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Margaret and Charles Juravinski Cancer Centre|
|Hamilton, Ontario, Canada, L8V 5C2|
|Cancer Care Ontario-London Regional Cancer Centre|
|London, Ontario, Canada, N6A 4L6|
|Mount Sinai Hospital - Toronto|
|Toronto, Ontario, Canada, M5G 1X5|
|Montreal, Quebec, Canada, H1T 2M4|
|Study Chair:||Elizabeth A. Eisenhauer, MD||Cancer Centre of Southeastern Ontario at Kingston General Hospital|