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Phase II Trial of Weekly or Every 3-week Ixabepilone for Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00593827
First Posted: January 15, 2008
Last Update Posted: March 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
US Oncology Research
Information provided by (Responsible Party):
R-Pharm
January 4, 2008
January 15, 2008
March 14, 2012
May 25, 2012
March 10, 2016
May 2008
August 2010   (Final data collection date for primary outcome measure)
Progression-Free Survival (PFS) at 6 Months (6-month PFS Rate): Proportion of Participants Progression Free at 6 Months [ Time Frame: From the date of randomization to 6-months on study ]
PFS at 6 months was defined as proportion of participants who neither progressed nor died before 6 months. Computed using Kaplan-Meier estimates.
Determine the proportion of patients who are progression free [ Time Frame: at 6 months ]
Complete list of historical versions of study NCT00593827 on ClinicalTrials.gov Archive Site
  • Median Progression Free Survival [ Time Frame: From the date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 25.7 months) ]
    PFS is defined as time interval from the date of randomization to the date of (first) progression or date of death. Participants who progressed or died were counted as events. Participants lost to follow-up were censored as of the last date of contact. Participants who started a new treatment before they progressed were censored as of the date of start of the new treatment. Participants who had not progressed or died were censored at the date of last follow-up. PFS (months) = (End date - date of randomization + 1)/30.4375.
  • Overall Response Rate (ORR) Based on Response Criteria in Solid Tumors [RECIST] [ Time Frame: Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months) ]

    ORR is defined as the proportion of responders (complete response [CR] + partial response [PR] in participants with measurable disease) in that arm among all randomized participants.

    CR: Disappearance of all evidence of target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions.

    Measurable disease: Lesions that can be accurately measured in at least one dimension (LD to be recorded) as ≥20 mm with conventional techniques (computed tomography [CT], magnetic resonance imaging [MRI], X-ray) or as ≥10 mm with spiral CT scan.

  • Best Response as Assessed With RECIST [ Time Frame: Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months) ]
    Determined based on the sequence of disease status with corresponding best response. PD=At least a 20% increase in the sum of LD of target lesions in reference to the smallest sum LD recorded or the appearance of 1 or more new lesions; SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD in reference to the smallest sum LD. NE=Participants who discontinued treatment secondary to toxicity or died (either before completion of 1 treatment cycle). Please refer outcome measure 3 for explanation of CR and PR. CR+PR+SD=overall disease control.
  • Overall Survival (OS) [ Time Frame: From the date of randomization to date of death (maximum participant OS of 26.3 months) ]

    Survival was measured as the date of randomization to the date of death. Participants who were alive at the time of the database lock or lost to follow-up were censored at the last known alive date. The distribution of overall survival was analyzed via the Kaplan Meier method in each arm.

    Survival time (months) = (End date - date of randomization + 1)/30.4375

  • Time to Response [ Time Frame: From the date of first dose to date of first PR or CR assessment ( maximum participant time to response of 8.3 months) ]

    Time to response is defined as the time from the start of treatment until the first (confirmed) CR or PR was recorded. Time to response was computed only for participants whose best response was PR or CR.

    CR: Disappearance of all target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions with reference to the baseline sum LD.

  • Duration of Response [ Time Frame: From the date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 17.4 months) ]
    Duration of overall response was defined as the period from the time first PR or CR was recorded until the first date of documented PD or death. Duration of response was computed for participants whose best response was either PR or CR. Participants who neither relapsed nor died were censored on the date of their last tumor assessment. Kaplan-Meier method was used to estimate the duration of response. Refer to outcome measures 3 and 4 for CR, PR, and PD.
  • Incidence of All Grades of Peripheral Neuropathy [ Time Frame: Assessed from the date of first study dose until at least 30 days after the last dose of study drug. Median time on study therapy was 12 weeks (range: 4-60 weeks for 16 mg/m^2 arm; 3-87 weeks for 40 mg/m^2 arm). ]
    All events of peripheral neuropathy were assessed and graded per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3. CTC Grade (GR) 1=Mild; GR2=Moderate; GR3=Severe or medically significant, not immediately life-threatening; and GR4=Life-threatening. All treatment-related and not related Neuropathy and Peripheral Neuropathy were included; serious adverse events (SAEs) were not included.
  • Median progression free survival [ Time Frame: at the end of the study ]
  • Overall response rate in patients with measurable disease [ Time Frame: at the end of the study ]
  • Clinical benefit rate (CR + PR + [SD > 6 months]) [ Time Frame: at the end of the study ]
  • Overall survival [ Time Frame: determined after patients have been followed for one-year post treatment ]
  • Incidence of All Grades of Peripheral Neuropathy [ Time Frame: as assessed throughout study as well as at the end of the study ]
Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia [ Time Frame: Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on study therapy was 12 weeks (range: 4-60 weeks for 16 mg/m^2 arm; 3-87 weeks for 40 mg/m^2 arm). ]
An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency or abuse; is life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization; or prolongs existing hospitalization. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment. GR=Grade.
Not Provided
 
Phase II Trial of Weekly or Every 3-week Ixabepilone for Patients With Metastatic Breast Cancer
Phase II Randomized Trial of Weekly and Every 3-week Ixabepilone in Metastatic Breast Cancer (MBC) Patients
The purpose of this study was to determine the effects of the weekly regimen of ixabepilone dosing compared to the once every 3 week dosing regimen in participants with metastatic breast cancer.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic Breast Cancer
  • Drug: Ixabepilone
    Injection, IV, Until progressive disease or intolerable toxicity Ixabepilone 16 mg/m^2 was administered as a 1-hour IV continuous infusion on Days 1, 8, and 15 in a 28-day cycle until progressive disease or intolerable toxicity.
    Other Names:
    • IXEMPRA
    • BMS-247550
  • Drug: Ixabepilone
    Injection, IV, Until progressive disease or intolerable toxicity Ixabepilone 40 mg/m^2 was administered as a 3-hour IV infusion on Day 1 of each 21-day cycle provided the subject met the retreatment criteria.
    Other Names:
    • IXEMPRA
    • BMS-247550
  • Active Comparator: Arm 1
    ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
    Intervention: Drug: Ixabepilone
  • Active Comparator: Arm 2
    ixabepilone 40 mg/m^2 every 3 weeks
    Intervention: Drug: Ixabepilone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
176
August 2010
August 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Has MBC that is measurable by RECIST or has nonmeasurable disease with serum CA27.29 (or CA15.3) ≥ 50
  • Has Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer
  • Prior chemotherapy is permitted with no limit on the number of prior regimens
  • Two weeks or more have elapsed since last chemotherapy or radiation treatment
  • Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2
  • Is female, ≥ 18 yrs of age
  • Protocol defined appropriate laboratory values
  • Negative pregnancy test within 7 calendar days prior to registration
  • Has signed a patient informed consent

Exclusion Criteria:

  • Had prior treatment with ixabepilone or other epothilones
  • Has HER2+ disease
  • Has a known, prior, severe (National Cancer Institute Common Terminology Criteria Adverse Events [NCI CTCAE] Grade 3-4) history of hypersensitivity reaction to a drug formulated in Cremophor ® EL (polyoxyethylated castor oil)
  • Is receiving concurrent immunotherapy, hormonal therapy or radiation therapy
  • Is receiving concurrent investigational therapy or has received such therapy within the past 30 days
  • Has peripheral neuropathy > Grade 1
  • Has evidence of central nervous system (CNS) involvement requiring radiation or steroid treatment. Participants with stable brain metastases who are off steroids at least 2 weeks are eligible
  • Is pregnant or breast feeding
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00593827
CA163-132
USOR 06-106
No
Not Provided
Not Provided
R-Pharm
R-Pharm
US Oncology Research
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
R-Pharm
February 2016

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