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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00049244
• Other study ID #: BMS-CA163-031
• Secondary ID: UCLA-0206011CDR0
• Status: Active, not recruiting
• Phase: Phase 1
• First received: November 12, 2002
• Last updated: January 27, 2017
• Start date: September 2002

Study information

• Verified date: January 2017
• Source: R-Pharm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• capecitabine

• ixabepilone

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
R-Pharm	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,