Randomized Study Evaluating Ixabepilone Plus Capecitabine or Docetaxel Plus Capecitabine in Metastatic Breast Cancer

PHASE2TerminatedINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

February 29, 2008

Primary Completion Date

March 31, 2010

Study Completion Date

March 31, 2010

Conditions
Breast Neoplasms
Interventions
DRUG

Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2

Ixabepilone, 40 mg/m\^2, administered as a 3-hour intravenous (IV) infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.

DRUG

Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2

Ixabepilone, 32 mg/m\^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.

DRUG

Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2

Docetaxel 75 mg/m\^2 administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.

Trial Locations (60)

10960

Hematology Oncology Associates of Rockland, Nyack

11042

Arena Oncology Associates, PC, Lake Success

18512

Hematology & Oncology Associates of Nepa, Dunmore

18901

Doylestown Hospital, Doylestown

19047

Regional Hematology Oncology, PC, Langhorne

St Mary Medical Center, Langhorne

19140

Local Institution, Philadelphia

19141

Albert Einstein Cancer Center, Philadelphia

19718

Local Institution, Newark

20007

Georgetown University Medical Center, Washington D.C.

20817

Center for Cancer & Blood Disorders, PC, Bethesda

21215

Sinai Hospital of Baltimore, Baltimore

23601

Peninsula Cancer Institute, Newport News

27889

Marion L Shepard Cancer Center, Washington

28054

Gaston Hematology and Oncology, Gastonia

29150

Santee Hematology/Oncology, Sumter

29406

Charleston Cancer Center, Charleston

29464

Lowcountry Hematology & Oncology, PA, Mt. Pleasant

30901

Medical Oncology Associates of Augusta, PC, Augusta

32209

Local Institution, Jacksonville

33176

Local Institution, Miami

35401

Dch Cancer Treatment Center, Tuscaloosa

37660

Kingsport Hematology Oncology, Kingsport

37920

The University of Tennessee Medical Center, Knoxville

39202

Jackson Oncology Associates, Pllc, Jackson

40202

University Medical Center, Inc, Louisville

40536

University of Kentucky, Lexington

43219

Mid Ohio Oncology/Hematology, Inc, dba The Mark H Zangmeister Center, Columbus

44302

Akron General Medical Center, Akron

44304

Summa Health System, Akron

44710

Local Institution, Canton

46321

Monroe Medical Associates, Munster

46526

Center for Cancer Care at Goshen Health System, Goshen

54601

Leah L Dietrich, MD, La Crosse

57104

Sanford Cancer Center Oncology Clinic, Sioux Falls

60099

Midwestern Regional Medical Center, Zion

60611

Northwestern University Feinberg School of Medicine, Chicago

61615

John W Kugler, MD, Peoria

67214

Cancer Center of Kansas, Wichita

70809

Hematology/Oncology Clinic, Baton Rouge

Mary Bird Perkins Cancer Center, Baton Rouge

75137

Edward L Middleman, MD, Duncanville

76092

Southlake Oncology, Southlake

77030

Section Chief Medical Oncology, Houston

78412

Cancer Specialists of South Texas, Corpus Christi

78463

Coastal Bend Cancer Center, Corpus Christi

78759

Austin Cancer Centers, Austin

79410

Jose A Figueroa, MD, Lubbock

87106

UNM Cancer Center, Albuquerque

87505

New Mexico Cancer Care Associates (NMCCA), Santa Fe

92037

Scripps Cancer Center, La Jolla

96813

Local Institution, Honolulu

99204

Providence Cancer Center, Spokane

06489

Cancer Center of Central Connecticut, Southington

08003

The Center for Cancer and Hematologic Disease, Cherry Hill

07601

The Cancer Center at Hackensack University Medical Center, Hackensack

07731

Howell Office Plaza, Howell Township

07112

Local Institution, Newark

08043

Cooper Hospital, Division of Hematology/Oncology, Voorhees Township

02895

Local Institution, Woonsocket

Sponsors

Lead Sponsor

All Listed Sponsors
lead

R-Pharm

INDUSTRY