This trial is active, not recruiting.

Condition breast cancer
Treatments capecitabine, ixabepilone
Phase phase 1
Sponsor Jonsson Comprehensive Cancer Center
Collaborator National Cancer Institute (NCI)
Start date September 2002
Trial identifier NCT00049244, BMS-CA163-031, CDR0000258052, NCI-G02-2120, UCLA-0206011


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2008.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).