NCT00244933

Gemcitabine Hydrochloride and Genistein in Treating Women With Stage IV Breast Cancer

Phase II Trial of Gemcitabine and Genistein in Metastatic Breast Cancer Patients With Biomarker Assays

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: Primary * Determine the objective response rate in patients with stage IV breast cancer treated with gemcitabine hydrochloride and genistein. Secondary * 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	genistein	Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
DRUG	gemcitabine	Gemcitabine IV-1000mg/m2: Days 1 \& 8 every 21 days
PROCEDURE	Tumor biopsy	Biopsy of tumor prior to dose of genistein (Novasoy)

Timeline

• Start date: 2004-02-01
• Primary completion: 2008-11-01
• Completion: 2009-10-01
• First posted: 2005-10-27
• Last updated: 2023-06-22
• Results posted: 2015-02-02

Locations

1 site across 1 country: United States