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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

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Metastases Drug: Ixabepilone + Capecitabine Drug: Capecitabine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 752 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2003
Actual Primary Completion Date : November 2006
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: A 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

Active Comparator: B Drug: Capecitabine
Tablet, Oral, 2500 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00080301


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Sponsors and Collaborators
R-Pharm
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00080301     History of Changes
Other Study ID Numbers: CA163-046
First Posted: March 30, 2004    Key Record Dates
Results First Posted: August 17, 2009
Last Update Posted: March 10, 2016
Last Verified: February 2016
Keywords provided by R-Pharm:
Metastatic Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Epothilones
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators