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Sponsors and Collaborators: |
Barbara Ann Karmanos Cancer Institute National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00244933 |
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.
Condition | Intervention | Phase |
Breast Cancer |
Drug: gemcitabine hydrochloride Drug: genistein Procedure: complementary or alternative medicine procedure |
Phase II |
Genetics Home Reference related topics: | breast cancer |
MedlinePlus related topics: | Breast Cancer Cancer |
Drug Information available for: | Gemcitabine hydrochloride Gemcitabine Genistein |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Gemcitabine and Genistein in Metastatic Breast Cancer Patients With Biomarker Assays |
Estimated Enrollment: | 36 |
Study Start Date: | February 2004 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed breast cancer
Measurable disease
No active CNS metastases
Hormone receptor status:
PATIENT CHARACTERISTICS:
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Prior adjuvant or neoadjuvant taxane-based therapy or taxane therapy for metastatic disease allowed
Endocrine therapy
At least 2 weeks since prior and no concurrent hormonal therapy
Radiotherapy
Surgery
Other
At least 1 week since prior soy supplements (e.g., soy-based pills, liquids, or concentrates)
No concurrent nutritional supplements, herbal agents, or high doses of antioxidants (e.g., vitamins C, D, or E) that may interact with, antagonize, alter, or imitate the potential effects of gemcitabine hydrochloride or genistein
United States, Michigan | |||||
Barbara Ann Karmanos Cancer Institute | |||||
Detroit, Michigan, United States, 48201-1379 | |||||
Sinai-Grace Hospital | |||||
Detroit, Michigan, United States, 48235 |
Barbara Ann Karmanos Cancer Institute |
National Cancer Institute (NCI) |
Study Chair: | Ding Wang, MD, PhD | Barbara Ann Karmanos Cancer Institute |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000446089, WSU-C-2597 |
First Received: | October 25, 2005 |
Last Updated: | October 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00244933 |
Health Authority: | United States: Federal Government |
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