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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00244933
• Other study ID #: 2597
• Secondary ID: P30CA022453WSU-C
• Status: Completed
• Phase: Phase 2
• Start date: February 2004
• Est. completion date: October 2009

Study information

• Verified date: May 2023
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: October 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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)

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate by RECIST Criteria Following	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.	every 2 courses until disease progression or death, up to 24 weeks