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Novel Epothilone Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer

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ClinicalTrials.gov Identifier: NCT00080301
Recruitment Status : Completed
First Posted : March 30, 2004
Results First Posted : August 17, 2009
Last Update Posted : March 10, 2016
Sponsor:
Information provided by:
R-Pharm

Tracking Information
First Submitted Date  ICMJE March 26, 2004
First Posted Date  ICMJE March 30, 2004
Results First Submitted Date  ICMJE May 1, 2009
Results First Posted Date  ICMJE August 17, 2009
Last Update Posted Date March 10, 2016
Study Start Date  ICMJE September 2003
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2010)
Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRRC) [ Time Frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity ]
PFS defined as the time in months from randomization to date of progression. Patients who died without a reported prior progression were considered to have progressed on date of death; those who didn't progress or die were censored on date of last tumor assessment. Median PFS time with 95% CI estimated using the Kaplan Meier product limit method.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00080301 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2010)
  • Overall Response Rate (ORR) Per IRRC [ Time Frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity ]
    Participants with best response of "Complete" or "Partial" according to Response Evaluation Criteria in Solid Tumors (RECIST) a 4-item scale wherein complete response=disappearance of all target lesions and partial response=30% decrease in the sum of the longest diameter of target lesions
  • Duration of Response Per IRRC [ Time Frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity ]
    Computed for all patients with a best response of "Partial" or "Complete" per RECIST (a 4-item scale as described in previous outcome measure), calculated from the time when these criteria were first met until the first date of documented progression or death.
  • Time to Response Per IRRC [ Time Frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity ]
    Time to response was summarized using descriptive statistics and was defined as the time from first dose of study treatment until measurement criteria were first met for Partial Response or Complete Response.
  • Overall Survival (OS) [ Time Frame: from date of randomization until death ]
    OS was defined as the time from randomization to death. Participants who did not die at the time of the analysis were censored at the latest follow-up date. Median OS with 95% CI was estimated using the Kaplan Meier product limit method.
  • Treatment-related Safety Summary [ Time Frame: safety was assessed on a continual basis every cycle while on-treatment and every 4 weeks post treatment until toxicities resolved or were deemed irreversible. ]
    Laboratory values, adverse events, and other symptoms were graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTC) Version 3.0
  • Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI) [ Time Frame: Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment. ]
    Quality of life, as measured by the FBSI, an 8-item, participant-reported instrument to measure symptoms. Each item has 5 possible responses ranging from 0 (not at all) to 4 (very much). The scoring was conducted according to the Functional Assessment of Chronic Illness Therapy manual, Version 4; higher scores reflect fewer symptoms.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Novel Epothilone Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer
Official Title  ICMJE A Phase III Trial of Novel Epothilone BMS-247550 Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With or Resistant to an Anthracycline and Who Are Taxane Resistant
Brief Summary The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine is better than capecitabine alone in shrinking or slowing the growth of the cancer in women with metastatic breast cancer who are resistant to taxane and received anthracycline chemotherapy. The safety of this treatment will also be studied.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Metastases
Intervention  ICMJE
  • Drug: Ixabepilone + Capecitabine

    Ixabepilone - Intravenous Solution, IV 40mg/m², Day 1 every 21 days, Until progression/unacceptable toxicity

    Capecitabine (Active Comparator) - Tablet, Oral, 2000 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity

    Other Names:
    • BMS-247550
    • IXEMPRA
    • Epothilone
  • Drug: Capecitabine
    Tablet, Oral, 2500 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: Ixabepilone + Capecitabine
  • Active Comparator: B
    Intervention: Drug: Capecitabine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2008)
752
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • Patients must have received either 2 or 3 prior chemotherapy regimens including adjuvant or neoadjuvant therapy.
  • Prior treatment must have included both an anthracycline (i.e., doxorubicin or epirubicin) and a taxane (i.e., paclitaxel or docetaxel).
  • Patients must have received a minimum cumulative dose of anthracycline or must be resistant to an anthracycline.
  • Patients must be resistant to taxane therapy.
  • Patients may not have any history of brain and/or leptomeningeal metastases.
  • Patients may not have CTC Grade 2 or greater neuropathy (motor or sensory).
  • Patients may have not have had prior treatment with an epothilone and/or capecitabine (i.e., Xeloda)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico,   Argentina,   Belgium,   Brazil,   Canada,   China,   France,   Germany,   Greece,   Hungary,   Italy,   Korea, Republic of,   Malaysia,   Peru,   Philippines,   Poland,   Spain,   Sweden,   Taiwan,   Thailand,   United Kingdom,   United States
Removed Location Countries Netherlands,   Puerto Rico
 
Administrative Information
NCT Number  ICMJE NCT00080301
Other Study ID Numbers  ICMJE CA163-046
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Study Director, Bristol-Myers Squibb
Study Sponsor  ICMJE R-Pharm
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account R-Pharm
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP