Cisplatin, Paclitaxel, and Everolimus in Treating Patients With Metastatic Breast Cancer

Completed · Phase 1

Conditions studied: Breast Cancer

In brief

RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving more than one drug (combination chemotherapy) together with everolimus may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of cisplatin, paclitaxel, and everolimus when given together for the treatment of patients with metastatic breast cancer.

Key facts

Study ID

NCT00680758

Run by

Vanderbilt-Ingram Cancer Center

People needed

18

Starts

2008-05-01

Expected to finish

2010-12-01

Last updated by the study team

2013-03-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• DISEASE CHARACTERISTICS:
• Histologically confirmed invasive mammary carcinoma
• Stage IV disease
• No locally recurrent breast cancer
• Patients with HER2/neu overexpressing tumors must have received prior trastuzumab (Herceptin®) in first-line treatment of metastatic breast cancer
• Patients with estrogen receptor- or progesterone receptor-expressing tumors must have received prior endocrine therapy (i.e., aromatase inhibitors, fulvestrant, tamoxifen, or ovarian ablation) in first-line treatment of metastatic breast cancer
• No symptomatic brain metastases
• Patients with a history of brain metastases must be clinically stable and not taking steroids or therapeutic anticonvulsants that are CYP3A4 modifiers
• Patients with asymptomatic brain metastases on prophylactic convulsants that are CYP3A4 modifiers are not eligible
• Hormone receptor status not specified
• PATIENT CHARACTERISTICS:
• Menopausal status not specified
• ECOG performance status 0-1
• Life expectancy ≥ 6 months
• ANC ≥ 1000/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Creatinine ≤ 1.5 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN (3 times ULN if liver metastasis present)
• SGOT and SGPT ≤ 1.5 times ULN (3 times ULN if liver metastasis present)
• Alkaline phosphatase ≤ 3 times ULN if liver metastasis present
• Able to swallow and retain oral medication
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after completion of study treatment
• Must be disease-free from prior invasive cancers for > 5 years with the exception of completely resected basal cell or squamous cell carcinoma of the skin or successfully treated cervical carcinoma in situ

You may not qualify if…

• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• Recovered from all prior treatment
• Must not have exceeded a total cumulative dose of life-time exposure of doxorubicin hydrochloride ≤ 360 mg/m² or epirubicin hydrochloride ≤ 640 mg/m²
• At least 2 weeks since other prior investigational drugs
• No prior resection of the stomach or small bowel
• No more than 4 prior chemotherapy regimens in the metastatic setting
• This restriction does not include endocrine therapies or single agent biologic therapies (i.e., trastuzumab)
• Concurrent radiotherapy to painful bone metastases or areas of impending bone fracture allowed as long as radiotherapy is initiated prior to study entry
• No concurrent trastuzumab
• No concurrent endocrine therapy
• No concurrent CYP3A4 modifiers
• No concurrent herbal supplement
• No other concurrent anticancer therapy (chemotherapy, radiotherapy, surgery, immunotherapy, hormonal therapy, or biological therapy)

Where it is running

• Vanderbilt-Ingram Cancer Center - Cool Springs — Nashville, Tennessee, United States
• Vanderbilt-Ingram Cancer Center at Franklin — Nashville, Tennessee, United States
• Sarah Cannon Cancer Center at Centennial Medical Center — Nashville, Tennessee, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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