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

This study is no longer recruiting patients.

Sponsors and Collaborators: Princess Margaret Hospital
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

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.

Condition Treatment or Intervention Phase
Male Breast Cancer
recurrent breast cancer
stage IV breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
 Drug: perifosine
 Procedure: chemotherapy
Phase II

MedlinePlus related topics:  Breast Cancer;   Male Breast Cancer
Genetics Home Reference related topics:  breast cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Perifosine in Patients With Recurrent or Refractory, Locally Advanced or Metastatic Breast Cancer

Further Study Details: 

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

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

Surgery

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

Other


Location Information


Canada, Ontario
      Cancer Care Ontario-London Regional Cancer Centre, London,  Ontario,  N6A 4L6,  Canada

      Margaret and Charles Juravinski Cancer Centre, Hamilton,  Ontario,  L8V 5C2,  Canada

      Ottawa Regional Cancer Centre, Ottawa,  Ontario,  K1H 1C4,  Canada

      Princess Margaret Hospital, Toronto,  Ontario,  M5G 2M9,  Canada

Study chairs or principal investigators

Natasha Leighl, MD,  Study Chair,  Princess Margaret Hospital   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000269901; PMH-PHL-014; NCI-5982; NCT00054145
Record last reviewed:  March 2005
Last Updated:  March 22, 2005
Record first received:  February 5, 2003
ClinicalTrials.gov Identifier:  NCT00054145
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005