Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Drugs used in chemotherapy such as perifosine 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 advanced soft tissue sarcoma.

Further Study Information

OBJECTIVES:

• Determine the 6-month progression-free rate, time to progression, and survival of patients with advanced soft tissue sarcoma treated with perifosine.

• Determine the objective tumor response status and duration of response in patients treated with this drug.

• Determine the pharmacokinetics of this drug in these patients.

• Determine the patterns of treatment failure and adverse event rate in patients treated with this drug.

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.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed advanced soft tissue sarcoma

• Measurable disease

• Lesions that have been previously irradiated must have progressed at least 25% since prior radiotherapy

• No uncontrolled brain metastases

• Previously treated brain metastases are allowed provided they are controlled for more than 8 weeks prior to study entry

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic

• Bilirubin no greater than upper limit of normal (ULN)

• AST no greater than 2.5 times ULN

Renal

• Creatinine no greater than ULN OR

• Creatinine clearance at least 60 mL/min

Cardiovascular

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No symptomatic cardiac arrhythmia despite appropriate therapy

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No prior allergic reactions attributed to compounds of similar chemical or biological composition to perifosine

• No other concurrent uncontrolled illness

• No ongoing or active infection

• No psychiatric illness or social situations that would preclude study compliance

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinoma

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 4 weeks since prior biologic therapy

• More than 4 weeks since prior immunotherapy

• No concurrent immunotherapy

• No concurrent immunomodulating agents

Chemotherapy

• No more than 2 prior cytotoxic chemotherapy regimens for metastatic sarcoma

• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

• No other concurrent chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

• More than 4 weeks since prior radiotherapy

• No concurrent radiotherapy

Surgery

• Not specified

Other

• Recovered from prior therapy

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No concurrent commercial or other investigational agents or therapies for the malignancy

• No other concurrent cytostatic or cytotoxic agents

Trial Contact Information

Trial Lead Organizations/Sponsors

Mayo Clinic Cancer Center

Howard H. Bailey

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00064324
Information obtained from ClinicalTrials.gov on December 14, 2011

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