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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Mayo Clinic
Rochester, Minnesota, United States
Progression-free rate
Time frame: 6 months
Survival time
Estimated using the method of Kaplan-Meier (Kaplan and Meier 1958) and Cox Proportional Hazards (Cox D. 1972) modeling.
Time frame: Time from regstration to death due to any cause, assessed up to 5 years
Time to disease progression
Estimated using the method of Kaplan-Meier (Kaplan and Meier 1958) and Cox Proportional Hazards (Cox D. 1972) modeling.
Time frame: Time from registration to documentation of disease progression, assessed up to 5 years
Duration of response
Time frame: Date at which the patient's objective status is first noted to be either a complete response (CR) or partial response (PR) to the date progression is documented, assessed up to 5 years
Time to treatment failure
Time frame: Time from the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal, assessed up to 5 years
Average change over time for PK variable(s)
Estimated and tested via appropriate methods (i.e. t-test or Wilcoxon tests).
Time frame: Days 1 and 15 of course 1 and day 1 of courses 2-6
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