Phase II Trial of Gemcitabine and Genistein in Metastatic Breast Cancer Patients With Biomarker Assays
- Determine the objective response rate in patients with stage IV breast cancer treated
with gemcitabine hydrochloride and genistein.
- Determine the duration of response and survival of patients treated with this regimen.
- Determine the time to disease progression in patients treated with this regimen.
- Determine the quantitative and qualitative toxic effects of this regimen in these
- Correlate plasma genistein levels with response in patients treated with this regimen.
OUTLINE: Patients receive oral genistein once daily on days -7 to 1. Patients also receive
gemcitabine hydrochloride IV on days 1 and 8 and oral genistein once daily on days 1-21.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate by RECIST criteria following
every 2 courses until disease progression or death
Amy Weise, DO
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|