Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-31 @ 2:16 PM
Study NCT ID:
NCT00244933
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2005-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Gemcitabine Hydrochloride and Genistein in Treating Women With Stage IV Breast Cancer
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Study Overview
Official Title:
Phase II Trial of Gemcitabine and Genistein in Metastatic Breast Cancer Patients With Biomarker Assays
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA022453 | NIH | None | https://reporter.nih.gov/quic… | View |
| WSU-C-2597 | OTHER | Barbara Ann Karmanos Cancer Institute | View |