Perifosine in Treating Patients With Recurrent, Refractory, Locally Advanced, or Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00054145|
Recruitment Status : Completed
First Posted : February 6, 2003
Last Update Posted : July 23, 2015
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 or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: perifosine||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study Of Perifosine In Metastatic Or Advanced Breast Cancer|
|Study Start Date :||June 2003|
|Actual Primary Completion Date :||April 2007|
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 ClinicalTrials.gov identifier (NCT number): NCT00054145
|Margaret and Charles Juravinski Cancer Centre|
|Hamilton, Ontario, Canada, L8V 5C2|
|Cancer Care Ontario-London Regional Cancer Centre|
|London, Ontario, Canada, N6A 4L6|
|Ottawa Regional Cancer Centre|
|Ottawa, Ontario, Canada, K1H 1C4|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Study Chair:||Natasha Leighl, MD, FRCPC||Princess Margaret Hospital, Canada|