Spots Global Cancer Trial Database for Perifosine in Treating Patients With Recurrent, Refractory, Locally Advanced, or Metastatic Breast Cancer

Study Description

Brief Summary: 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.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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