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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate by RECIST criteria following

Outcome Time Frame:

every 2 courses until disease progression or death

Safety Issue:

No

Principal Investigator

Amy Weise, DO

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000446089

NCT ID:

NCT00244933

Start Date:

February 2004

Completion Date:

October 2009

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201