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



Status:Terminated
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:February 2008
End Date:March 2010

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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

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.


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
We found this trial at
60
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303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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1 Akron General Ave
Akron, Ohio 44307
(330) 344-6000
Akron General Medical Center It
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Akron, Ohio 44304
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Albuquerque, New Mexico 87106
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Austin, Texas 78759
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2401 W Belvedere Ave
Baltimore, Maryland 21215
(410) 601-9000
Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
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Baton Rouge, Louisiana 70809
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Baton Rouge, Louisiana 70809
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6410 Rockledge Dr #660
Bethesda, Maryland 20817
(301) 571-0019
Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
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Canton, Ohio 44178
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Charleston, South Carolina
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Cherry Hill, New Jersey 08003
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Corpus Christi, Texas 78412
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Corpus Christi, Texas 78463
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Doylestown, Pennsylvania 18901
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Duncanville, Texas 75137
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Dunmore, Pennsylvania 18512
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Gastonia, North Carolina 28054
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Honolulu, Hawaii 96813
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Houston, Texas 77030
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Howell, New Jersey 07731
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Jackson, Mississippi 39202
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Jacksonville, Florida 32256
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Kingsport, Tennessee 37660
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Knoxville, Tennessee 37920
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La Crosse, Wisconsin 54601
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La Jolla, California 92037
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Lake Success, New York 11042
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Langhorne, Pennsylvania 19047
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Langhorne, Pennsylvania 19047
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Lexington, Kentucky
859) 257-9000
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Louisville, Kentucky 40202
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Lubbock, Texas 79410
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Miami, Florida 33136
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Mt Pleasant, South Carolina 29464
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Munster, Indiana 46321
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Newark, Delaware 19713
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Newark, New Jersey 07102
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Newport News, Virginia 23601
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Peoria, Illinois 61615
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Philadelphia, Pennsylvania 19102
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Philadelphia, Pennsylvania 19141
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Santa Fe, New Mexico 87505
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1309 W 17th Street
Sioux Falls, South Dakota 57104
(605) 328-8000
Sanford Cancer Center-Oncology Clinic Sanford Health is an integrated health system headquartered in the Dakotas...
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Southington, Connecticut 06489
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Southlake, Texas 76092
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Spokane, Washington 99204
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Sumter, South Carolina 29150
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Tuscaloosa, Alabama
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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Washington, North Carolina 27889
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818 N. Emporia, #403
Wichita, Kansas 67214
(316) 262-4467
Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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Woonsocket, Rhode Island 02895
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Zion, Illinois 60099
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