Clinical trial NCT00546364: Randomized Study Evaluating Ixabepilone Plus Capecitabine or Docetaxel Plus Capecitabine in Metastatic Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Neoplasms
Lead sponsor: R-Pharm
Sponsor class: INDUSTRY
First posted: 2007-10-18
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: Baseline to 6 weeks (end of Cycle 2)
measure: Percentage of Participants With Best Response to Treatment of Complete or Partial
timeFrame: Baseline to 6 weeks (end of Cycle 2)
Secondary outcomes:
measure: Percentage of Triple-negative (TN) Participants With Best Response to Treatment of Complete or Partial
timeFrame: Baseline to 6 weeks (end of Cycle 2)
measure: Percentage of Nontriple-negative (NTN) Participants With Best Response to Treatment of Complete or Partial Per Cohort
timeFrame: Baseline to 6 weeks (end of Cycle 2)
measure: 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
timeFrame: Baseline to end of Cycle 1 (21 days), continuously
measure: Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade
timeFrame: Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cycle
measure: Number of Participants With Abnormalities in Serum Chemistry Laboratory Results
timeFrame: Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cycle
measure: Time to Progression
timeFrame: Baseline to date progressive disease reported
measure: Duration of Response
timeFrame: Baseline (date of randomization) to date CR or PR criteria first met
measure: Median Number of Treatment Cycles
timeFrame: Day 1 to end of Cycle 18, maximum (54 weeks)
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Dch Cancer Treatment Center
state: Alabama
city: La Jolla
country: United States
facility: Scripps Cancer Center
state: California
city: Southington
country: United States
facility: Cancer Center of Central Connecticut
state: Connecticut
city: Newark
country: United States
facility: Local Institution
state: Delaware
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Jacksonville
country: United States
facility: Local Institution
state: Florida
city: Miami
country: United States
facility: Local Institution
state: Florida
city: Augusta
country: United States
facility: Medical Oncology Associates of Augusta, PC
state: Georgia
city: Honolulu
country: United States
facility: Local Institution
state: Hawaii
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Peoria
country: United States
facility: John W Kugler, MD
state: Illinois
city: Zion
country: United States
facility: Midwestern Regional Medical Center
state: Illinois
city: Goshen
country: United States
facility: Center for Cancer Care at Goshen Health System
state: Indiana
city: Munster
country: United States
facility: Monroe Medical Associates
state: Indiana
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: University Medical Center, Inc
state: Kentucky
city: Baton Rouge
country: United States
facility: Hematology/Oncology Clinic
state: Louisiana
city: Baton Rouge
country: United States
facility: Mary Bird Perkins Cancer Center
state: Louisiana
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Bethesda
country: United States
facility: Center for Cancer & Blood Disorders, PC
state: Maryland
city: Jackson
country: United States
facility: Jackson Oncology Associates, Pllc
state: Mississippi
city: Cherry Hill
country: United States
facility: The Center for Cancer and Hematologic Disease
state: New Jersey
city: Hackensack
country: United States
facility: The Cancer Center at Hackensack University Medical Center
state: New Jersey
city: Howell
country: United States
facility: Howell Office Plaza
state: New Jersey
city: Newark
country: United States
facility: Local Institution
state: New Jersey
city: Voorhees
country: United States
facility: Cooper Hospital, Division of Hematology/Oncology
state: New Jersey
city: Albuquerque
country: United States
facility: UNM Cancer Center
state: New Mexico
city: Santa Fe
country: United States
facility: New Mexico Cancer Care Associates (NMCCA)
state: New Mexico
city: Lake Success
country: United States
facility: Arena Oncology Associates, PC
state: New York
city: Nyack
country: United States
facility: Hematology Oncology Associates of Rockland
state: New York
city: Gastonia
country: United States
facility: Gaston Hematology and Oncology
state: North Carolina
city: Washington
country: United States
facility: Marion L Shepard Cancer Center
state: North Carolina
city: Akron
country: United States
facility: Akron General Medical Center
state: Ohio
city: Akron
country: United States
facility: Summa Health System
state: Ohio
city: Canton
country: United States
facility: Local Institution
state: Ohio
city: Columbus
country: United States
facility: Mid Ohio Oncology/Hematology, Inc, dba The Mark H Zangmeister Center
state: Ohio
city: Doylestown
country: United States
facility: Doylestown Hospital
state: Pennsylvania
city: Dunmore
country: United States
facility: Hematology & Oncology Associates of Nepa
state: Pennsylvania
city: Langhorne
country: United States
facility: Regional Hematology Oncology, PC
state: Pennsylvania
city: Langhorne
country: United States
facility: St Mary Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Local Institution
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Cancer Center
state: Pennsylvania
city: Woonsocket
country: United States
facility: Local Institution
state: Rhode Island
city: Charleston
country: United States
facility: Charleston Cancer Center
state: South Carolina
city: Mt Pleasant
country: United States
facility: Lowcountry Hematology & Oncology, PA
state: South Carolina
city: Sumter
country: United States
facility: Santee Hematology/Oncology
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Cancer Center Oncology Clinic
state: South Dakota
city: Kingsport
country: United States
facility: Kingsport Hematology Oncology
state: Tennessee
city: Knoxville
country: United States
facility: The University of Tennessee Medical Center
state: Tennessee
city: Austin
country: United States
facility: Austin Cancer Centers
state: Texas
city: Corpus Christi
country: United States
facility: Cancer Specialists of South Texas
state: Texas
city: Corpus Christi
country: United States
facility: Coastal Bend Cancer Center
state: Texas
city: Duncanville
country: United States
facility: Edward L Middleman, MD
state: Texas
city: Houston
country: United States
facility: Section Chief Medical Oncology
state: Texas
city: Lubbock
country: United States
facility: Jose A Figueroa, MD
state: Texas
city: Southlake
country: United States
facility: Southlake Oncology
state: Texas
city: Newport News
country: United States
facility: Peninsula Cancer Institute
state: Virginia
city: Spokane
country: United States
facility: Providence Cancer Center
state: Washington
city: La Crosse
country: United States
facility: Leah L Dietrich, MD
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: