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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Dietary Supplement: genistein; Drug: gemcitabine; Procedure: Tumor biopsy

• Registration Number: NCT00244933
• Lead Sponsor: Barbara Ann Karmanos Cancer Institute

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.

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.

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2005-10-25
• Study First Submitted QC: 2005-10-25
• Study First Posted: 2005-10-27
• Primary Completion: 2008-11
• Study Completion: 2009-10
• Results First Submitted: 2015-01-12
• Results First Submitted QC: 2015-01-30
• Results First Posted: 2015-02-02
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-22
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 19

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gemcitabine, genistein (Novasoy), Tumor biopsy	genistein	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.
Gemcitabine, genistein (Novasoy), Tumor biopsy	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.
Gemcitabine, genistein (Novasoy), Tumor biopsy	gemcitabine	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.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate by RECIST Criteria Following	every 2 courses until disease progression or death, up to 24 weeks	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.

Trial Locations

Locations (1)

Barbara Ann Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States