Perifosine in Treating Patients With Advanced 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: NCT00053924
Recruitment Status : Completed
First Posted : February 6, 2003
Last Update Posted : July 23, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University Health Network, Toronto

February 5, 2003
February 6, 2003
July 23, 2015
May 2003
May 2006   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00053924 on Archive Site
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Perifosine in Treating Patients With Advanced Pancreatic Cancer
A Phase 2 Study Of Perifosine As Second Line Therapy For Advanced Pancreatic Carcinoma

RATIONALE: Drugs used in chemotherapy 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 locally advanced or metastatic pancreatic cancer.


  • Determine the efficacy of perifosine, in terms of 6-month survival, in patients with advanced adenocarcinoma of the pancreas.
  • Determine the safety and tolerability of this drug in these patients.
  • Determine median survival time and the 1-year survival rate of patients treated with this drug.
  • Determine the objective response rate (partial and complete), response duration, and time to progression in patients treated with this drug.
  • Determine the toxicity of this drug in these patients.

OUTLINE: Patients receive oral perifosine daily for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 17-37 patients will be accrued for this study within 15 months.

Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
Pancreatic Cancer
Drug: perifosine
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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May 2006   (Final data collection date for primary outcome measure)


  • Histologically or cytologically confirmed adenocarcinoma of the pancreas not amenable to curative local therapy

    • Metastatic OR locally advanced
  • No known brain metastases
  • No ascites that required therapeutic paracentesis on at least 2 occasions within the past 6 weeks



  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • Not specified


  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • AST/ALT no greater than 2.5 times ULN (5 times ULN with liver metastases)


  • Creatinine normal OR
  • Creatinine clearance at least 60 mL/min


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


  • No gastrointestinal (GI) tract disease resulting in the inability to take oral medication or a requirement for IV alimentation
  • No uncontrolled inflammatory bowel disease
  • No active peptic ulcer disease


  • 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 active malignant disease that could interfere with interpretation of study results
  • No ongoing active infection
  • No other uncontrolled concurrent illness
  • No psychiatric illness or social situation that would preclude study compliance


Biologic therapy

  • Not specified


  • No more than 1 prior chemotherapy regimen for metastatic or locally advanced disease

    • Prior chemotherapy, given as a radiosensitizer, allowed in addition to single-line therapy
  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy

  • Not specified


  • At least 3 weeks since prior radiotherapy likely to have myelotoxic effects (more than 3,000 cGy to fields including substantial marrow) and recovered


  • No prior GI surgery affecting absorption


  • No concurrent antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational agents
  • No other concurrent anticancer agents or therapies
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
CDR0000269586 ( Registry Identifier: PDQ (Physician Data Query) )
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University Health Network, Toronto
University Health Network, Toronto
National Cancer Institute (NCI)
Study Chair: Malcolm J. Moore, MD Princess Margaret Hospital, Canada
University Health Network, Toronto
July 2015

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