Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer - Full Text View

Purpose

The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine (Xeloda) provides measurable clinical benefits over capecitabine alone in women with metastatic breast cancer. Patients should have previously received an anthracycline and a taxane. The safety of this treatment will also be studied.

Condition	Intervention	Phase
Cancer Breast Cancer	Drug: Ixabepilone + Capecitabine Drug: Capecitabine	Phase III

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer

ChemIDplus related topics:

Ixabepilone Capecitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Phase III Study of Novel Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With an Anthracycline and a Taxane

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Overall Survival from Date of Randomization to Death [ Time Frame: at end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time To Progression [ Time Frame: at end of study ] [ Designated as safety issue: No ]
Response Rate and Duration of Response in patients with Measureable disease [ Time Frame: at end of study ] [ Designated as safety issue: No ]
Quality of Life [ Time Frame: at end of study ] [ Designated as safety issue: No ]

Enrollment:	1220
Study Start Date:	November 2003
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Ixabepilone + Capecitabine Lypholized powder/Diluent for solution for injection/Tablets, IV/Oral, 40 mg/m2 + 2000 mg/m2, Ixabepilone on Day 1 and Capecitabine twice daily Days 1-14 of 21 day cycle up to 18 cycles and beyond if clinically benefitting
B: Active Comparator	Drug: Capecitabine Tablet, Oral, 2500 mg/m2, Capecitabine twice daily Days 1-14 of 21 day cycle

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Patients must have received prior treatment which included both an anthracycline (i.e., doxorubicin or epirubicin) and a taxane (i.e., paclitaxel or docetaxel).
Patients must have received no more than two prior chemotherapy regimens. Patients who have not received treatment for metastatic disease must have relapsed within one year.
Patients may not have any history of brain and/or leptomeningeal metastases.
Patients may not have Grade 2 or worse neuropathy at the time of study entry.
Patients may not have had prior treatment with any epothilones and/or capecitabine (i.e. Xeloda)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082433

Show 226 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators


Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA163-048
First Received:	May 7, 2004
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00082433
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Capecitabine

Skin Diseases

Epothilones

Breast Neoplasms

Taxane

Breast Diseases

Additional relevant MeSH terms:

Antimetabolites

Neoplasms

Antimetabolites, Antineoplastic

Neoplasms by Site

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Mitosis Modulators

Tubulin Modulators

Antimitotic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00082433