Gemcitabine Hydrochloride and Genistein in Treating Women With Stage IV Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and genistein, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine hydrochloride together with genistein may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine hydrochloride together with genistein works in treating women with stage IV breast cancer.
Dietary Supplement: genistein
Procedure: Tumor biopsy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Gemcitabine and Genistein in Metastatic Breast Cancer Patients With Biomarker Assays|
- Objective Response Rate by RECIST Criteria Following [ Time Frame: every 2 courses until disease progression or death, up to 24 weeks ] [ Designated as safety issue: No ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Duration of Response [ Time Frame: From the time the last patient comes off study treatment for one year ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: From the time the last patient comes off study treatment for one year to monitor survival ] [ Designated as safety issue: No ]
- Time to Disease Progression [ Time Frame: From the time that treatment is initiated until the time restaging indicates progressive disease. ] [ Designated as safety issue: No ]
- Duration of Survival [ Time Frame: At 1 year following study treatment ] [ Designated as safety issue: No ]
- Qualitative and Quantitative Toxicities [ Time Frame: 30 days following treatment ] [ Designated as safety issue: Yes ]
- Correlate Responses With Plasma Genistein Levels [ Time Frame: At course 1 day -7, course 1 day -1 (before and 4 hours after dose), course 2 day 1 (before and 4 hours after dose) ] [ Designated as safety issue: No ]
- In Vivo Effects of Genistein in Breast Cancer Tissue Biomarkers (Ki67, TUNEL Assay, p-Akt, NF-kB, Immunohistochemistry and cDNA Microarray Analysis) [ Time Frame: At baseline (pre-genistein treatment) and 7 days following genistein treatment ] [ Designated as safety issue: No ]
|Study Start Date:||February 2004|
|Study Completion Date:||October 2009|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
Experimental: Gemcitabine, genistein (Novasoy), Tumor biopsy
Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
Dietary Supplement: genistein
Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
Other Name: NovasoyDrug: gemcitabine
Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days
Other Names:Procedure: Tumor biopsy
Biopsy of tumor prior to dose of genistein (Novasoy)
- 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 patients.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00244933
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|Principal Investigator:||Amy Weise, DO||Barbara Ann Karmanos Cancer Institute|