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Perifosine in Treating Patients With Recurrent, Refractory, Locally Advanced, or Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00054145
First received: February 5, 2003
Last updated: July 23, 2008
Last verified: March 2005

February 5, 2003
July 23, 2008
June 2003
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Complete list of historical versions of study NCT00054145 on ClinicalTrials.gov Archive Site
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Perifosine in Treating Patients With Recurrent, Refractory, Locally Advanced, or Metastatic Breast Cancer
A Phase 2 Study Of Perifosine In Metastatic Or Advanced Breast Cancer

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 recurrent, refractory, locally advanced, or metastatic breast cancer.

OBJECTIVES:

  • Determine the objective tumor response rate in patients with recurrent or refractory, locally advanced or metastatic breast cancer treated with perifosine.
  • Determine the toxicity of this drug in these patients.
  • Determine the stable disease rate, time to disease progression, objective response duration, and duration of stable disease in patients treated with this drug.
  • Correlate potential endpoints, including phosphorylated ERK, PKB, and SAPK, phosphorylated PKC alpha, beta, and gamma isoforms, p21 ^WAF1; and activated capase-3 in tumor biopsies, with clinical outcome in patients treated with this drug.

OUTLINE: This is an open-label, multicenter study.

Patients receive a loading dose of oral perifosine on days 1 and 2 and once daily on days 3-21 during course 1. Patients receive oral perifosine once daily on days 1-21 in each subsequent course. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) may receive 2 additional courses beyond the CR.

PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study within 6-12 months.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Drug: perifosine
Not Provided
Leighl NB, Dent S, Clemons M, Vandenberg TA, Tozer R, Warr DG, Crump RM, Hedley D, Pond GR, Dancey JE, Moore MJ. A Phase 2 study of perifosine in advanced or metastatic breast cancer. Breast Cancer Res Treat. 2007 Apr 26; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed breast cancer

    • Recurrent or refractory, locally advanced or metastatic disease
  • At least 1 unidimensionally measurable lesion

    • At least 20 mm by conventional techniques OR 10 mm by spiral CT scan
    • Previously irradiated lesions are not considered measurable unless they have demonstrated progression before study entry
    • No measurable disease limited to bone lesions
  • No known brain metastases
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Male or female

Menopausal status

  • Not specified

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 3 months

Hematopoietic

  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • No history of hemolytic disorder

Hepatic

  • Bilirubin no greater than 1.25 times upper limit of normal (ULN)
  • AST/ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present)

Renal

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

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No evidence of cardiac dysfunction

Gastrointestinal

  • No history of biliary flow obstruction
  • No abnormalities of the gastrointestinal tract that would preclude study drug absorption
  • No active peptic ulcer disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No ongoing or active infection
  • No poorly controlled diabetes mellitus
  • No other uncontrolled illness
  • No prior allergic reactions to compounds of similar chemical or biological composition to perifosine
  • No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No more than 2 prior lines of chemotherapy for advanced disease, excluding adjuvant chemotherapy
  • Prior adjuvant chemotherapy allowed
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy

  • At least 4 weeks since prior endocrine therapy

    • Multiple lines of endocrine therapy for advanced disease allowed

Radiotherapy

  • At least 4 weeks since prior radiotherapy and recovered

    • Prior radiotherapy for metastatic disease allowed

Surgery

  • No prior major gastric surgery
  • Prior surgery, including for metastatic disease, allowed

Other

  • No other concurrent anticancer or investigational agents
  • No concurrent antiretroviral therapy in HIV-positive patients
  • Concurrent bisphosphonates allowed
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00054145
CDR0000269901, PMH-PHL-014, NCI-5982
Not Provided
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Princess Margaret Hospital, Canada
National Cancer Institute (NCI)
Study Chair: Natasha Leighl, MD, FRCPC Princess Margaret Hospital, Canada
National Cancer Institute (NCI)
March 2005

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