Perifosine in Treating Patients With Advanced Solid Tumors

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: NCT00005794
Recruitment Status : Completed
First Posted : October 8, 2003
Last Update Posted : October 19, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:

RATIONALE: Perifosine may stop the growth of tumor cells by stopping blood flow to the tumor.

PURPOSE: Phase I trial to study the effectiveness of perifosine in treating patients who have advanced solid tumors.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: perifosine Phase 1

Detailed Description:


  • Determine the maximum tolerated dose (MTD) of perifosine on a loading dose/maintenance dose schedule in patients with advanced solid tumors.
  • Determine the qualitative and quantitative toxic effects of this drug in these patients.
  • Determine the pharmacokinetics of this drug in these patients.
  • Investigate the relationship between pharmacokinetic parameters and toxicity of this drug in these patients.
  • Determine the recommended starting dose for phase II trials on this drug schedule in these patients.
  • Evaluate the pharmacodynamic parameters on peripheral blood lymphocytes both before and during drug administration in these patients.
  • Determine any changes in the MTD with prolonged administration (3 months, 6 months) of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive a loading dose of oral perifosine 4 times a day for 4-8 doses followed by a daily maintenance dose. Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression.

Cohorts of 3-6 patients receive escalating loading doses and maintenance doses of perifosine until the maximum tolerated dose (MTD) of each is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxic effects.

PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase I Trial of Perifosine on a Loading Dose/Maintenance Dose Schedule in Patients With Advanced Cancer
Study Start Date : February 2000
Actual Study Completion Date : July 2003

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed locally unresectable or metastatic malignancy that is considered incurable
  • Refractory to further treatment with known forms of effective therapy
  • No clinically active CNS metastasis



  • 18 and over

Performance status:

  • 0-2

Life expectancy:

  • At least 12 weeks


  • WBC at least 4,000/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin normal
  • SGOT no greater than 2.5 times upper limit of normal


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


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 6 months after study participation
  • Maintaining a reasonable state of nutrition consistent with weight maintenance

    • No recent history of weight loss greater than 10% of current body weight
  • No frequent vomiting/poor alimentation
  • No other serious concurrent medical illness that would preclude study therapy


Biologic therapy:

  • No concurrent immunotherapy


  • At least 4 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) and recovered
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy

    • Patients who have progressive disease while being treated with LHRH agonists, antiestrogens, or antitestosterones for at least 3 months may remain on these agents if in their best interest


  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy


  • See Disease Characteristics
  • At least 21 days since prior major surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005794

United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Sponsors and Collaborators
University of Wisconsin, Madison
National Cancer Institute (NCI)
Study Chair: Lynn Van Ummersen, MD University of Wisconsin, Madison

Responsible Party: University of Wisconsin, Madison Identifier: NCT00005794     History of Changes
Other Study ID Numbers: 1999-355
P30CA014520 ( U.S. NIH Grant/Contract )
CDR0000067752 ( Other Identifier: UWCCC? Unknown )
First Posted: October 8, 2003    Key Record Dates
Last Update Posted: October 19, 2015
Last Verified: October 2015

Keywords provided by University of Wisconsin, Madison:
unspecified adult solid tumor, protocol specific