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

NCT ID: NCT00244933

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2009-10-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

genistein

Intervention Type: DIETARY_SUPPLEMENT

Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.

gemcitabine

Intervention Type: DRUG

Gemcitabine IV-1000mg/m2: Days 1 \& 8 every 21 days

Tumor biopsy

Intervention Type: PROCEDURE

Biopsy of tumor prior to dose of genistein (Novasoy)

Interventions

genistein

Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.

Intervention Type: DIETARY_SUPPLEMENT

gemcitabine

Gemcitabine IV-1000mg/m2: Days 1 \& 8 every 21 days

Intervention Type: DRUG

Tumor biopsy

Biopsy of tumor prior to dose of genistein (Novasoy)

Intervention Type: PROCEDURE

Other Intervention Names

Novasoy; Gemcitabine hydrochloride; Gemzar®

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed breast cancer

• Stage IV disease
• Clinical and/or radiological evidence of metastatic disease
• Measurable disease

• Prior radiotherapy allowed provided there is ≥ 1 measurable disease site outside the radiation field
• No active CNS metastases

• Previously treated CNS metastases allowed provided disease is stable for ≥ 3 months without steroids or antiseizure medications
• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Sex

• Female

Menopausal status

• Not specified

Performance status

• SWOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 10 g/dL

Hepatic

• Bilirubin ≤3.0 mg/dL
• AST and ALT ≤ 2.5 times upper limit of normal

Renal

• Creatinine ≤ 1.5 mg/dL

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No serious systemic disorder that would preclude study compliance
• No history of another malignancy except curatively treated carcinoma of the cervix or basal cell or squamous cell skin cancer in complete remission
• No unresolved bacterial infection requiring antibiotic treatment
• No known HIV-1 positivity

PRIOR CONCURRENT THERAPY:

Biologic therapy

• At least 3 weeks since prior biologic therapy

Chemotherapy

• Prior adjuvant chemotherapy allowed
• Prior adjuvant or neoadjuvant taxane-based therapy or taxane therapy for metastatic disease allowed

• Patient must have failed therapy within 2 years after completion of treatment
• At least 3 weeks since prior chemotherapy
• No more than 2 prior cytotoxic chemotherapy regimens for metastatic disease
• No prior gemcitabine hydrochloride
• No other concurrent chemotherapy

Endocrine therapy

• See Disease Characteristics
• At least 2 weeks since prior and no concurrent hormonal therapy

• Must have documented disease progression during prior hormonal therapy

Radiotherapy

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy and recovered
• No concurrent radiotherapy

Surgery

• At least 3 weeks since prior surgery

Other

• At least 3 weeks since prior investigational therapy
• At least 1 week since prior soy supplements (e.g., soy-based pills, liquids, or concentrates)

• Dietary soy as part of a meal (e.g., tofu) allowed once a week
• 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

• A single daily multivitamin is allowed
• No other concurrent immunotherapy
• No other concurrent experimental medication
• Concurrent anticoagulants, appetite stimulants, and replacement steroids allowed

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Barbara Ann Karmanos Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Lawrence E. Flaherty

Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy Weise, DO

Role: PRINCIPAL_INVESTIGATOR

Barbara Ann Karmanos Cancer Institute

Locations

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

P30CA022453

Identifier Type: NIH

Identifier Source: secondary_id

View Link

WSU-C-2597

Identifier Type: OTHER

Identifier Source: secondary_id

2597

Identifier Type: -

Identifier Source: org_study_id