BMS-247550 Plus Capecitabine in Treating Patients With Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining BMS-247550 with capecitabine in treating patients who have metastatic breast cancer that has not responded to previous chemotherapy with a taxane and an anthracycline.

Detailed Description
-----------------
OBJECTIVES: Determine the maximum tolerated dose of BMS-247550 and capecitabine, on 2 different schedules, in patients with metastatic breast cancer previously treated with a taxane and an anthracycline. Determine the safety profile of this regimen in these patients. Determine, preliminarily, any antitumor activity of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 groups. Group I: Patients receive BMS-247550 IV over 3 hours on day 1 and oral capecitabine twice daily on days 1-14. Group II: Patients receive BMS-247550 IV over 1 hour on days 1-3 and capecitabine as in group I. Treatment in both groups repeats every 3 weeks for 2-18 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 6 patients receive escalating doses of BMS-247550 and capecitabine until the maximum tolerated dose (MTD) is determined for each group. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity. Additional patients are treated at the MTD. Patients are followed for at least 30 days and then every 3 months thereafter. PROJECTED ACCRUAL: Approximately 34-60 patients will be accrued for this study within 8-12 months.

Official Title
-----------------
A Phase I Study of BMS-247550 in Combination With Capecitabine in Patients With Metastatic Breast Cancer Previously Treated With a Taxane and an Anthracycline

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: capecitabine
* Drug: ixabepilone


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed breast cancer Metastatic disease by radiography or histology Must have received prior chemotherapy with a taxane and an anthracycline in the adjuvant or metastatic setting No more than 2 prior chemotherapy regimens in the metastatic setting Measurable or evaluable disease Bone lesions not measurable Primary breast lesions not measurable if assessed only by physical exam No active brain metastasis No cerebral edema by CT scan or MRI No progression since prior imaging studies No requirement for steroids No clinical symptoms of brain metastasis Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age 18 and over Sex Not specified Menopausal status Not specified Performance status ECOG 0-1 Life expectancy At least 3 months Hematopoietic Absolute neutrophil count at least 2,000/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9.0 g/dL Hepatic Bilirubin no greater than 1.5 times upper limit of normal (ULN) ALT no greater than 2.5 times ULN Renal Creatinine less than 1.5 times ULN Cardiovascular No uncontrolled or significant cardiovascular disease No myocardial infarction within the past year No uncontrolled angina within the past year No history of congestive heart failure No history of atrial or ventricular arrhythmias No history of second- or third-degree heart block No uncontrolled hypertension Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No hypersensitivity to Cremophor EL or fluorouracil No prior intolerance to fluoropyrimidines No other serious uncontrolled medical disorder or active infection that would preclude study No dementia or altered mental status that would preclude study No grade 2 or greater neuropathy (neuromotor or neurosensory) PRIOR CONCURRENT THERAPY: Biologic therapy See Chemotherapy Prior immunotherapy allowed No concurrent trastuzumab (Herceptin) No concurrent immunotherapy Chemotherapy See Disease Characteristics At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or doxorubicin HCl liposome) At least 2 years since prior high-dose chemotherapy with bone marrow transplantation or peripheral blood stem cell support No prior epothilone, capecitabine, or continuous-infusion fluorouracil No other concurrent chemotherapy Endocrine therapy Prior hormonal therapy allowed No concurrent hormonal therapy Concurrent hormone replacement therapy allowed Radiotherapy At least 3 weeks since prior radiotherapy No prior radiotherapy to more than 25% of the bone marrow No concurrent therapeutic radiotherapy Surgery Not specified Other At least 3 weeks since prior investigational cytotoxic agents No concurrent warfarin for therapeutic anticoagulation Low-dose warfarin allowed for implanted ports or indwelling catheters No other concurrent experimental anticancer medications No other concurrent antitumor therapy Concurrent bisphosphonates for palliation of bone metastases allowed if initiated before study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: capecitabine|nan|
|Drug: ixabepilone|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent breast cancer, stage IV breast cancer