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IXTEND: A Randomized Phase 2 Study to Evaluate the Combination of Ixabepilone Plus Capecitabine or Capecitabine Plus Docetaxel in the Treatment of Metastatic Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Neoplasms

Thank you

Trial Information

IXTEND: A Randomized Phase 2 Study to Evaluate the Combination of Ixabepilone Plus Capecitabine or Capecitabine Plus Docetaxel in the Treatment of Metastatic Breast Cancer


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

Baseline to 6 weeks (end of Cycle 2)

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA163-131

NCT ID:

NCT00546364

Start Date:

February 2008

Completion Date:

March 2010

Related Keywords:

  • Breast Neoplasms
  • Breast Neoplasms
  • Neoplasms

Name

Location

Sinai Hospital of BaltimoreBaltimore, Maryland  21225
Mary Bird Perkins Cancer CenterBaton Rouge, Louisiana  70809
Akron General Medical CenterAkron, Ohio  44302
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
Midwestern Regional Medical CenterZion, Illinois  60099
DCH Cancer Treatment CenterTuscaloosa, Alabama  35401
Summa Health SystemAkron, Ohio  44312
Center for Cancer Care at Goshen Health SystemGoshen, Indiana  46526
Jackson Oncology Associates, PLLCJackson, Mississippi  39202
Gaston Hematology and OncologyGastonia, North Carolina  28054
Doylestown HospitalDoylestown, Pennsylvania  18901
Scripps Cancer CenterLa Jolla, California  92037
Charleston Cancer CenterCharleston, South Carolina  29406
The Center for Cancer and Hematologic DiseaseCherry Hill, New Jersey  08003
Local InstitutionCincinnati, Ohio  
Georgetown University Medical CenterWashington, District of Columbia  20007
University of KentuckyLexington, Kentucky  40536-0098
Local InstitutionFort Lauderdale, Florida  
Local InstitutionNew Brunswick, New Jersey  
Local InstitutionDuncansville, Pennsylvania  
Cancer Specialists of South TexasCorpus Christi, Texas  78412
Santee Hematology/OncologySumter, South Carolina  29150
Northwestern University Feinberg School of MedicineChicago, Illinois  60611
Peninsula Cancer InstituteNewport News, Virginia  23601
Hematology & Oncology Associates of NEPADunmore, Pennsylvania  18512
Marion L Shepard Cancer CenterWashington, North Carolina  27889
Local InstitutionProvidence, Rhode Island  
The Cancer Center at Hackensack University Medical CenterHackensack, New Jersey  07601
Cancer Center of KansasWichita, Kansas  67214
Hematology/Oncology ClinicBaton Rouge, Louisiana  70808
Howell Office PlazaHowell, New Jersey  07731
Coastal Bend Cancer CenterCorpus Christi, Texas  78404
Local InstitutionHonolulu, Hawaii  
Local InstitutionNewark, Delaware  
Cancer Center of Central ConnecticutSouthington, Connecticut  
Arena Oncology Associates, PCGreat Neck, New York  11021
Lowcountry Hematology & Oncology, PaMt. Pleasant, South Carolina  29464
Hematology Oncology Associates of RocklandNyack, New York  10960
Kingsport Hematology OncologyKingsport, Tennessee  37660
University Medical Center, IncLouisville, Kentucky  40202
Providence Cancer CenterSpokane, Washington  99204
Monroe Medical AssociatesMunster, Indiana  46321
Medical Oncology Associates of Augusta, PCAugusta, Georgia  30901
John W Kugler, MDPeoria, Illinois  61615
Center for Cancer & Blood Disorders, PCBethesda, Maryland  20817
Cooper Hospital, Division of Hematology/OncologyVoorhees, New Jersey  08043
UNM Cancer CenterAlbuquerque, New Mexico  87106
New Mexico Cancer Care Associates (NMCCA)Santa Fe, New Mexico  87505
Mid Ohio Oncology/Hematology, Inc, dba The Mark H Zangmeister CenterColumbus, Ohio  43219
St Mary Medical CenterLanghorne, Pennsylvania  19047
Regional Hematology Oncology, PCLanghorne, Pennsylvania  19047
Sanford Cancer Center Oncology ClinicSioux Falls, South Dakota  57104
The University of Tennessee Medical CenterKnoxville, Tennessee  37920
Austin Cancer CentersAustin, Texas  78759
Edward L Middleman, MDDuncanville, Texas  75137
Section Chief Medical OncologyHouston, Texas  77030
Jose A Figueroa, MDLubbock, Texas  79410
Southlake OncologySouthlake, Texas  76092
Leah L Dietrich, MDLa Crosse, Wisconsin  54601