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

NCT00546364 | Terminated Phase 2 Results

• 1 other identifier: CA163-131
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 60

Brief Summary

The purpose of this study is to assess the effect of ixabepilone plus capecitabine or docetaxel plus capecitabine on shrinking or slowing the growth of metastatic breast cancer in women. The safety of this combination therapy will also be evaluated.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)

  RECIST definitions: Complete reponse (CR)=disappearance of all nontarget lesions; partial response (PR)=at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD; stable disease (SD)=neither PR nor progressive disease (PD) criteria were met; PD=at least 20% increase in the sum of the LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline. Tumor status assessed by investigator.

  Baseline to 6 weeks (end of Cycle 2)

• Percentage of Participants With Best Response to Treatment of Complete or Partial

  The tumor response rate is defined as the number of participants with a best tumor response of CR or PR (as assessed by the investigator according to RECIST criteria), divided by the number of participants randomized in that arm.

  Baseline to 6 weeks (end of Cycle 2)

Secondary Outcomes (8)

• Percentage of Triple-negative (TN) Participants With Best Response to Treatment of Complete or Partial

  Baseline to 6 weeks (end of Cycle 2)

• Percentage of Nontriple-negative (NTN) Participants With Best Response to Treatment of Complete or Partial Per Cohort

  Baseline to 6 weeks (end of Cycle 2)

• Number of Participants With Death, Adverse Events (AEs), Drug-related AEs, Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation (AEDs), Drug-related AEDs, and Drug-related Peripheral Neuropathy

  Baseline to end of Cycle 1 (21 days), continuously

• Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade

  Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cycle

• Number of Participants With Abnormalities in Serum Chemistry Laboratory Results

  Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cycle

Study Arms (3)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

ACTIVE COMPARATOR

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

Interventions

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

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.

Also known as: IXEMPRA®, BMS-247550

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

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

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.

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

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

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with metastatic breast cancer
• Measurable disease
• Up to 1 chemotherapy regimen is acceptable. Participants who have received paclitaxel in the neoadjuvant or adjuvant setting acceptable, only if the last dose of paclitaxel was received 12 months or less before the treatment. There is no timeframe for prior paclitaxel in the metastatic setting.
• Human epidermal growth factor receptor 2-positive participants allowed if they have progressed after receiving treatment with trastuzumab or lapatinib
• Eastern Cooperative Oncology Group Performance status of 0-1
• Age younger than 18 years
• Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 4 weeks after the last dose of investigational products

You may not qualify if:

• More than 1 chemotherapy regimen for the treatment of metastatic breast cancer
• Prior treatment with any epothilone, capecitabine, or docetaxel
• Prior radiation must not have included 30% or more of major bone marrow-containing areas (pelvis, lumbar spine). If prior radiation was less than 30%, a minimum interval of 2 weeks must be allowed between the last radiation treatment and administration of study medication. There must be at least 1 week between focal/palliative radiation and administration of study medication.
• Any current or previous history of brain and/or leptomeningeal metastases
• Neuropathy greater than Grade 2
• Any concurrent malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix
• Uncontrolled diabetes mellitus
• Chronic hepatitis
• HIV-positive status
• Administration of trastuzumab, lapatinib, bevacizumab, or other systemic treatment for cancer must be discontinued 28 days prior to study medication. Hormonal anticancer agents must be discontinued at least 14 days prior to study medication. Hormonal replacement therapy is acceptable
• Biphosphonates for palliation of bone metastases allowed if initiated at least 7 days before study entry

Sponsors & Collaborators

• R-Pharm: lead

Study Sites (60)

Dch Cancer Treatment Center

Tuscaloosa, Alabama, 35401, United States

Location

Scripps Cancer Center

La Jolla, California, 92037, United States

Location

Cancer Center of Central Connecticut

Southington, Connecticut, 06489, United States

Location

Local Institution

Newark, Delaware, 19718, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Local Institution

Jacksonville, Florida, 32209, United States

Location

Local Institution

Miami, Florida, 33176, United States

Location

Medical Oncology Associates of Augusta, PC

Augusta, Georgia, 30901, United States

Location

Local Institution

Honolulu, Hawaii, 96813, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

John W Kugler, MD

Peoria, Illinois, 61615, United States

Location

Midwestern Regional Medical Center

Zion, Illinois, 60099, United States

Location

Center for Cancer Care at Goshen Health System

Goshen, Indiana, 46526, United States

Location

Monroe Medical Associates

Munster, Indiana, 46321, United States

Location

Cancer Center of Kansas

Wichita, Kansas, 67214, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

University Medical Center, Inc

Louisville, Kentucky, 40202, United States

Location

Hematology/Oncology Clinic

Baton Rouge, Louisiana, 70809, United States

Location

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Center for Cancer & Blood Disorders, PC

Bethesda, Maryland, 20817, United States

Location

Jackson Oncology Associates, Pllc

Jackson, Mississippi, 39202, United States

Location

The Center for Cancer and Hematologic Disease

Cherry Hill, New Jersey, 08003, United States

Location

The Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Howell Office Plaza

Howell Township, New Jersey, 07731, United States

Location

Local Institution

Newark, New Jersey, 07112, United States

Location

Cooper Hospital, Division of Hematology/Oncology

Voorhees Township, New Jersey, 08043, United States

Location

UNM Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

New Mexico Cancer Care Associates (NMCCA)

Santa Fe, New Mexico, 87505, United States

Location

Arena Oncology Associates, PC

Lake Success, New York, 11042, United States

Location

Hematology Oncology Associates of Rockland

Nyack, New York, 10960, United States

Location

Gaston Hematology and Oncology

Gastonia, North Carolina, 28054, United States

Location

Marion L Shepard Cancer Center

Washington, North Carolina, 27889, United States

Location

Akron General Medical Center

Akron, Ohio, 44302, United States

Location

Summa Health System

Akron, Ohio, 44304, United States

Location

Local Institution

Canton, Ohio, 44710, United States

Location

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

Columbus, Ohio, 43219, United States

Location

Doylestown Hospital

Doylestown, Pennsylvania, 18901, United States

Location

Hematology & Oncology Associates of Nepa

Dunmore, Pennsylvania, 18512, United States

Location

Regional Hematology Oncology, PC

Langhorne, Pennsylvania, 19047, United States

Location

St Mary Medical Center

Langhorne, Pennsylvania, 19047, United States

Location

Local Institution

Philadelphia, Pennsylvania, 19140, United States

Location

Albert Einstein Cancer Center

Philadelphia, Pennsylvania, 19141, United States

Location

Local Institution

Woonsocket, Rhode Island, 02895, United States

Location

Charleston Cancer Center

Charleston, South Carolina, 29406, United States

Location

Lowcountry Hematology & Oncology, PA

Mt. Pleasant, South Carolina, 29464, United States

Location

Santee Hematology/Oncology

Sumter, South Carolina, 29150, United States

Location

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, 57104, United States

Location

Kingsport Hematology Oncology

Kingsport, Tennessee, 37660, United States

Location

The University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

Austin Cancer Centers

Austin, Texas, 78759, United States

Location

Cancer Specialists of South Texas

Corpus Christi, Texas, 78412, United States

Location

Coastal Bend Cancer Center

Corpus Christi, Texas, 78463, United States

Location

Edward L Middleman, MD

Duncanville, Texas, 75137, United States

Location

Section Chief Medical Oncology

Houston, Texas, 77030, United States

Location

Jose A Figueroa, MD

Lubbock, Texas, 79410, United States

Location

Southlake Oncology

Southlake, Texas, 76092, United States

Location

Peninsula Cancer Institute

Newport News, Virginia, 23601, United States

Location

Providence Cancer Center

Spokane, Washington, 99204, United States

Location

Leah L Dietrich, MD

La Crosse, Wisconsin, 54601, United States

Location

Related Links

• Investigator Inquiry form

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ixabepilone; Capecitabine; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: BMS Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2007
• First Posted: October 18, 2007
• Study Start: February 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: March 10, 2016
• Results First Posted: June 1, 2011

Record last verified: 2016-02

Locations

US (60)