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Perifosine in Treating Patients With Advanced Soft Tissue Sarcoma
This study is ongoing, but not recruiting participants.
Study NCT00064324   Information provided by National Cancer Institute (NCI)
First Received: July 8, 2003   Last Updated: July 23, 2008   History of Changes

July 8, 2003
July 23, 2008
June 2003
 
 
 
Complete list of historical versions of study NCT00064324 on ClinicalTrials.gov Archive Site
 
 
 
Perifosine in Treating Patients With Advanced Soft Tissue Sarcoma
A Phase II Study Of Perifosine In Soft Tissue Sarcoma

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.

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.

Phase II
Interventional
Treatment, Open Label
Sarcoma
Drug: perifosine
 
Bailey HH, Mahoney MR, Ettinger DS, Maples WJ, Fracasso PM, Traynor AM, Erlichman C, Okuno SH. Phase II study of daily oral perifosine in patients with advanced soft tissue sarcoma. Cancer. 2006 Nov 15;107(10):2462-7.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00064324
 
CDR0000315381, MAYO-MC0276, NCI-5972
Mayo Clinic
National Cancer Institute (NCI)
Study Chair: Howard H. Bailey, MD University of Wisconsin, Madison
National Cancer Institute (NCI)
April 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP