Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Perifosine in Treating Patients With Advanced Soft Tissue Sarcoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI MAYO-MC0276 NCI-5972, NCT00064324, 5972

Objectives

1. Determine the 6-month progression-free rate, time to progression, and survival of patients with advanced soft tissue sarcoma treated with perifosine.
2. Determine the objective tumor response status and duration of response in patients treated with this drug.
3. Determine the pharmacokinetics of this drug in these patients.
4. Determine the patterns of treatment failure and adverse event rate in patients treated with this drug.

Entry 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

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

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/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

A total of 17-46 patients will be accrued for this study within 9-12 months.

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.

Bailey HH, Mahoney MR, Ettinger DS, et al.: Phase II study of daily oral perifosine in patients with advanced soft tissue sarcoma. Cancer 107 (10): 2462-7, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Mayo Clinic Cancer Center

Howard Bailey, MD, Protocol chair		Ph: 608-263-8624; 800-622-8922 Email: hhbailey@facstaff.wisc.edu

Registry Information
Official Title		A Phase II Study Of Perifosine In Soft Tissue Sarcoma
Trial Start Date		2003-06-13
Registered in ClinicalTrials.gov		NCT00064324
Date Submitted to PDQ		2003-06-03
Information Last Verified		2004-04-19
NCI Grant/Contract Number		P30-CA15083

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