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

February 9, 2016 updated by: R-Pharm

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.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

176

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Birmingham Hematology & Oncology Associates Llc
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Hematology Oncology Associates
      • Sedona, Arizona, United States, 86336
        • Northern Arizona Hematology & Oncology Associates
      • Tucson, Arizona, United States, 85704
        • Arizona Oncology Associates D.B.A. Hematology Oncology
    • California
      • Murrieta, California, United States, 92562
        • Southwest Cancer Care
    • Florida
      • Hudson, Florida, United States, 34667
        • Florida Cancer Institute
      • Ocala, Florida, United States, 34471
        • Ocala Oncology Center
      • Ocoee, Florida, United States, 34761
        • Cancer Centers Of Florida, P.A
    • Illinois
      • Niles, Illinois, United States, 60714
        • Cancer Care & Hematology Specialists of Chicagoland
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Central Indiana Cancer Centers
      • Terre Haute, Indiana, United States, 47802
        • Hope Center
    • Maryland
      • Columbia, Maryland, United States, 21044
        • Maryland Oncology Hematology, P.A.
      • Westminster, Maryland, United States, 21157
        • Alliance Hematology Oncology, PA
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Minnesota Oncology Hematology, P.A.
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Missouri Cancer Associates
      • Kansas City, Missouri, United States, 64131
        • Kansas City Cancer Center, LLC
      • St. Louis, Missouri, United States, 63141
        • Arch Medical Services, INC.
    • Nevada
      • Henderson, Nevada, United States, 89074
        • Comprehensive Cancer Center of Nevada
    • New Jersey
      • Morristown, New Jersey, United States, NJ
        • Hematology-Oncology Assoc. Of Northern Nj, Pa
    • New Mexico
      • Santa Fe, New Mexico, United States, 87505
        • New Mexico Cancer Care Associates
    • New York
      • Amsterdam, New York, United States, 12010
        • New York Oncology Hematology, P.C.
      • Rochester, New York, United States, 14623
        • Interlakes Oncology & Hematology, P.C.
    • North Carolina
      • Durham, North Carolina, United States, 27704
        • Regional Cancer Care
      • Raleigh, North Carolina, United States, 27607
        • Raleigh Hematology Oncology Associates
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Cancer Centers of the Carolinas
    • Texas
      • Arlington, Texas, United States, 76014
        • Texas Cancer Center
      • Austin, Texas, United States, 78731
        • Texas Oncology-Central Austin Cancer Center
      • Beaumont, Texas, United States, 77702
        • Mamie Mcfaddin Ward Cancer Center Texas Oncology
      • Bedord, Texas, United States, 76022
        • Texas Oncology
      • Dallas, Texas, United States, 75230
        • Texas Cancer Center at Medical City
      • Dallas, Texas, United States, 75231
        • Texas Oncology
      • Dallas, Texas, United States, 75237
        • Texas Oncology/Methodist Charlton Cancer Ctr
      • Dallas, Texas, United States, 75246
        • Baylor Sammons Cancer Ctr
      • Dallas, Texas, United States, 75246
        • Texas Oncology Sammons Cancer Center
      • Denton, Texas, United States, 76210
        • Texas Cancer Center
      • Fort Worth, Texas, United States, 76104
        • Texas Oncology
      • Garland, Texas, United States, 75942
        • Texas Oncology
      • Houston, Texas, United States, 77024
        • Texas Oncology
      • Lewisville, Texas, United States, 75067
        • Texas Oncology - Lake Vista Cancer Center
      • Longview, Texas, United States, 75601
        • Longview Cancer Center
      • Mcallen, Texas, United States, 78503
        • South Texas Cancer Center
      • Mesquite, Texas, United States, 75150
        • Texas Cancer Center of Mesquite
      • Midland, Texas, United States, 78701
        • Texas Oncology, PA
      • Odessa, Texas, United States, 79761
        • Texas Oncology - Odessa
      • Paris, Texas, United States, 75460
        • Paris Regional Cancer Center Lab
      • Sherman, Texas, United States, 75090
        • Texas Cancer Center - Sherman
      • Sugar Land, Texas, United States, 77479
        • Texas Oncology Cancer Center - Sugar Land
      • Tyler, Texas, United States, 75702
        • Tyler Cancer Center
      • Waco, Texas, United States, 76712
        • Texas Oncology Cancer Care and Research Center
      • Webster, Texas, United States, 77598
        • Deke Slayton Cancer Center
    • Virginia
      • Salem, Virginia, United States, 24153
        • Oncology & Hematology Associates Of Southwest Virginia, Inc.
    • Washington
      • Edmonds, Washington, United States, 98026
        • Puget Sound Cancer Centers
      • Seattle, Washington, United States, 98133
        • Puget Sound Cancer Centers
      • Spokane, Washington, United States, 99218
        • Evergreen Hematology and Oncology
      • Spokane, Washington, United States, 99202
        • Cancer Care Northwest
      • Vancouver, Washington, United States, 98684
        • Northwest Cancer Specialists, PC
      • Yakima, Washington, United States, 98902
        • Yakima Valley Memorial Hospital/North Star Lodge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1
ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
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:
  • BMS-247550
  • IXEMPRA
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:
  • BMS-247550
  • IXEMPRA
Active Comparator: Arm 2
ixabepilone 40 mg/m^2 every 3 weeks
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:
  • BMS-247550
  • IXEMPRA
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:
  • BMS-247550
  • IXEMPRA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the date of randomization to 6-months on study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 25.7 months)
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.

Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months)
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.
Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months)
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

From the date of randomization to date of death (maximum participant OS of 26.3 months)
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.

From the date of first dose to date of first PR or CR assessment ( maximum participant time to response of 8.3 months)
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.
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)
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.
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).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

January 4, 2008

First Submitted That Met QC Criteria

January 4, 2008

First Posted (Estimate)

January 15, 2008

Study Record Updates

Last Update Posted (Estimate)

March 10, 2016

Last Update Submitted That Met QC Criteria

February 9, 2016

Last Verified

February 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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