Stage IV Breast Cancer Clinical Trial
Official title:
Carboplatin, Gemcitabine, and Mifepristone for Advanced Breast Cancer and Recurrent or Persistent Epithelial Ovarian Cancer
This phase I trial studies the side effects and best dose of gemcitabine hydrochloride and mifepristone when given together with carboplatin in treating patients with breast cancer that is metastatic or cannot be removed by surgery or recurrent or persistent ovarian epithelial, fallopian tube, or primary peritoneal cancer. Drugs used in chemotherapy, such as carboplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Steroid hormones can cause the growth of cancer cells. Hormone therapy using mifepristone may fight breast and ovarian cancer by lowering the amount of steroid hormone the body makes. Giving carboplatin and gemcitabine hydrochloride together with mifepristone may be an effective treatment for breast, ovarian epithelial, fallopian tube, or primary peritoneal cancer.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of
mifepristone when given in combination with carboplatin and gemcitabine (gemcitabine
hydrochloride).
SECONDARY OBJECTIVES:
I. To determine the safety and tolerability of mifepristone in combination with carboplatin
and gemcitabine.
II. To describe the toxicities seen with carboplatin, gemcitabine, and mifepristone
combination therapy.
TERTIARY OBJECTIVES:
I. To correlate expression of biomarkers (e.g. glucocorticoid receptor [GR], androgen
receptor [AR], estrogen receptor [ER], and progesterone receptor [PR]) with treatment
outcomes.
II. To correlate serum and intratumoral mifepristone concentrations after two doses of
mifepristone (in patients with easily accessible tumor who consent to an optional research
biopsy).
OUTLINE: This is a dose-escalation study of mifepristone.
Patients receive mifepristone orally (PO) once daily (QD) on days 0, 1, 7, and 8, and
carboplatin intravenously (IV) over 30 minutes and gemcitabine hydrochloride IV over 30-60
minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression
or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 18 months.
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