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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00244933
First received: October 25, 2005
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Dietary Supplement: genistein
Drug: gemcitabine
Procedure: Tumor biopsy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Gemcitabine and Genistein in Metastatic Breast Cancer Patients With Biomarker Assays

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • Objective response rate by RECIST criteria following [ Time Frame: every 2 courses until disease progression or death ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of response [ Time Frame: From the time the last patient comes off study treatment for one year ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: From the time the last patient comes off study treatment for one year to monitor survival ] [ Designated as safety issue: No ]
  • Time to disease progression [ Time Frame: From the time that treatment is initiated until the time restaging indicates progressive disease. ] [ Designated as safety issue: No ]
  • Duration of survival [ Time Frame: At 1 year following study treatment ] [ Designated as safety issue: No ]
  • Qualitative and quantitative toxicities [ Time Frame: 30 days following treatment ] [ Designated as safety issue: Yes ]
  • Correlate responses with plasma genistein levels [ Time Frame: At course 1 day -7, course 1 day -1 (before and 4 hours after dose), course 2 day 1 (before and 4 hours after dose) ] [ Designated as safety issue: No ]
  • In vivo effects of genistein in breast cancer tissue biomarkers (Ki67, TUNEL assay, p-Akt, NF-kB, immunohistochemistry and cDNA microarray analysis) [ Time Frame: At baseline (pre-genistein treatment) and 7 days following genistein treatment ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: February 2004
Study Completion Date: October 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Dietary Supplement: genistein
Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
Other Name: Novasoy
Drug: gemcitabine
Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days
Other Names:
  • Gemcitabine hydrochloride
  • Gemzar®
Procedure: Tumor biopsy
Biopsy of tumor prior to dose of genistein (Novasoy)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00244933

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Principal Investigator: Amy Weise, DO Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00244933     History of Changes
Other Study ID Numbers: CDR0000446089, P30CA022453, WSU-C-2597
Study First Received: October 25, 2005
Last Updated: May 8, 2014
Health Authority: United States: Federal Government

Keywords provided by Barbara Ann Karmanos Cancer Institute:
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Genistein
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Anticarcinogenic Agents
Protective Agents
Protein Kinase Inhibitors
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 26, 2014