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

NCT00244933 | Completed Phase 2 Results DMC

• 3 other identifiers: 2597P30CA022453WSU-C-2597
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Gemcitabine, genistein (Novasoy), Tumor biopsy

EXPERIMENTAL

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.

Dietary Supplement: genistein; Drug: gemcitabine; Procedure: Tumor biopsy

Interventions

genistein DIETARY_SUPPLEMENT

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

Also known as: Novasoy

Gemcitabine, genistein (Novasoy), Tumor biopsy

gemcitabine DRUG

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

Also known as: Gemcitabine hydrochloride, Gemzar®

Gemcitabine, genistein (Novasoy), Tumor biopsy

Tumor biopsy PROCEDURE

Biopsy of tumor prior to dose of genistein (Novasoy)

Gemcitabine, genistein (Novasoy), Tumor biopsy

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Genistein; Gemcitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Isoflavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines

Limitations and Caveats

Although the study is designed to accrue 18 response evaluable participants in the first stage, the decision was made to close the study after 17 patients because of lack of efficacy.

Results Point of Contact

• Title: Amy Weise, M.D.
• Organization: Barbara Ann Karmanos Cancer Institute

weisea@karmanos.org

313-576-8599

Study Officials

• Amy Weise, DO

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: October 25, 2005
• First Posted: October 27, 2005
• Study Start: February 1, 2004
• Primary Completion: November 1, 2008
• Study Completion: October 1, 2009
• Last Updated: June 22, 2023
• Results First Posted: February 2, 2015

Record last verified: 2023-05

Locations

US (1)