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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00244933
Enrollment
19
Registered
2005-10-27
Start date
2004-02-29
Completion date
2009-10-31
Last updated
2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

stage IV breast cancer, recurrent breast cancer

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.

Interventions

DIETARY_SUPPLEMENTgenistein

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

DRUGgemcitabine

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

PROCEDURETumor biopsy

Biopsy of tumor prior to dose of genistein (Novasoy)

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Barbara Ann Karmanos Cancer Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 120 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Objective Response Rate by RECIST Criteria Followingevery 2 courses until disease progression or death, up to 24 weeksPer 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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. genistein: Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days. gemcitabine: Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days Tumor biopsy: Biopsy of tumor prior to dose of genistein (Novasoy)
19
Total19

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyNot response evaluable2

Baseline characteristics

CharacteristicGemcitabine, Genistein (Novasoy), Tumor Biopsy
Age, Continuous53 years
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
11 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
8 Participants
Region of Enrollment
United States
19 participants
Sex: Female, Male
Female
19 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
2 / 19
serious
Total, serious adverse events
5 / 19

Outcome results

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.

Time frame: every 2 courses until disease progression or death, up to 24 weeks

ArmMeasureValue (NUMBER)
Gemcitabine & GenisteinObjective Response Rate by RECIST Criteria Following0 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026