Perifosine in Treating Patients With Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00059982
Recruitment Status : Completed
First Posted : May 7, 2003
Last Update Posted : June 24, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

May 6, 2003
May 7, 2003
June 24, 2013
July 2003
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Complete list of historical versions of study NCT00059982 on Archive Site
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Perifosine in Treating Patients With Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer
Phase II Trial Of Perifosine In Locally Advanced, Unresectable Or Metastatic Pancreatic Adenocarcinoma

RATIONALE: Perifosine may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who have locally advanced, unresectable, or metastatic pancreatic cancer.


  • Determine the activity of perifosine, in terms of objective response, in patients with locally advanced, unresectable, or metastatic pancreatic cancer.
  • Determine the response duration, progression-free survival, and overall survival of patients treated with this drug.
  • Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral perifosine every 6 hours for a total of 6 doses and then once daily in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 3 years.

PROJECTED ACCRUAL: A total of 35-84 patients will be accrued for this study within 21 months.

Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
Pancreatic Cancer
Drug: perifosine
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Marsh Rde W, Rocha Lima CM, Levy DE, Mitchell EP, Rowland KM Jr, Benson AB 3rd. A phase II trial of perifosine in locally advanced, unresectable, or metastatic pancreatic adenocarcinoma. Am J Clin Oncol. 2007 Feb;30(1):26-31.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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August 2005
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  • Histologically confirmed adenocarcinoma of the pancreas
  • Locally advanced, unresectable, or metastatic disease
  • Measurable disease
  • No known brain metastases



  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified


  • WBC at least 3,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL


  • AST no greater than 2 times upper limit of normal (ULN)
  • Bilirubin no greater than 2 times ULN


  • Creatinine no greater than 1.4 mg/dL


  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other concurrent illness that would preclude study participation


Biologic therapy

  • Not specified


  • No prior chemotherapy for pancreatic cancer
  • More than 6 months since prior chemotherapy for other diseases

Endocrine therapy

  • Not specified


  • At least 4 weeks since prior radiotherapy and recovered


  • At least 4 weeks since prior surgery and recovered


  • No other concurrent investigational agents for pancreatic cancer
  • No concurrent combination antiretroviral therapy for HIV-positive patients
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Robert de W. Marsh, MD University of Florida
Investigator: Caio Max S. Rocha Lima, MD H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
August 2004

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