Temozolomide in Treating Women With Advanced Breast Cancer
Recruitment status was Active, not recruiting
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 temozolomide in treating women who have advanced breast cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Trial of Temodal 4 Hourly in Progressive Breast Cancer|
|Study Start Date:||May 1998|
OBJECTIVES: I. Assess the therapeutic activity of temozolomide in terms of tumor response, progression free and overall survival in women with advanced breast cancer. II. Assess the extent of ATase depletion and DNA methylation in the peripheral blood of these patients undergoing this regimen and investigate the relationship between these parameters and tumor response.
OUTLINE: Patients receive oral temozolomide every 4 hours for a total of 5 doses. Treatment continues every 28 days for a minimum of 2 courses and a maximum of 1 year in the absence of unacceptable toxicity or disease progression. Patients are followed at 30 days, and then every 2 months thereafter.
PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study.
|Christie Hospital N.H.S. Trust|
|Manchester, England, United Kingdom, M20 4BX|
|Study Chair:||Anthony Howell, MD||Christie Hospital NHS Foundation Trust|