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A Study Comparing Eribulin Mesylate and Ixabepilone in Causing or Exacerbating Neuropathy in Patients With Advanced Breast Cancer

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ClinicalTrials.gov Identifier: NCT00879086
Recruitment Status : Completed
First Posted : April 9, 2009
Last Update Posted : July 23, 2014
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Brief Summary:
The purpose of this study in patients with advanced breast cancer is to compare the incidence and severity of neuropathy adverse events for the two treatment groups (eribulin versus ixabepilone) using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) grading.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: eribulin mesylate Drug: ixabepilone Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Randomized, Open-Label Study Comparing Eribulin Mesylate and Ixabepilone in Causing or Exacerbating Neuropathy in Patients With Advanced Breast Cancer
Study Start Date : March 2009
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: 1 Drug: eribulin mesylate

E7389 (eribulin mesylate) given at a dose of 1.4 mg/m^2 as a 2 - 5 minute intravenous (IV) bolus on Days 1 and 8 of a 21-day cycle.

The Treatment Phase will include six cycles. Patients may enter the Extension Phase for additional cycles following the sixth cycle of treatment.

Other Name: E7389

Active Comparator: 2 Drug: ixabepilone

Ixabepilone given at a starting dose of 32 or 40 mg/m^2 (as per approved labeling) as a 3-hour IV infusion on Day 1 of a 21-day cycle.

The Treatment Phase will include six cycles. Patients may enter the Extension Phase for additional cycles following the sixth cycle of treatment.





Primary Outcome Measures :
  1. Percent of subjects with neuropathy adverse events (AEs) graded according to NCI CTCAE (version 3.0) and coded according to the current version of Medical Dictionary for Regulatory Activities (MedDRA). [ Time Frame: Neuropathy assessments are performed at the start of Cycles 2-6 and subsequently at every third cycle, end-of-treatment visit, and post-treatment follow-up. ]

Secondary Outcome Measures :
  1. Neuropathy assessed by patient neurotoxicity questionnaire and vibration sensibility. [ Time Frame: Assessments are performed at the start of Cycles 2-6 and every third cycle, end-of-treatment visit, and post-treatment follow-up. ]
  2. Incidence of myalgia/arthralgia AEs. [ Time Frame: From the time subject is consented to when she completes the either 21 day or 42 day post-treatment follow-up visit. ]
  3. General safety assessed by monitoring all AEs and serious AEs, laboratory measurements, vital signs, and physical exams. [ Time Frame: Safety is assessed from the time subject is consented to when she completes the either 21 day or 42 day post-treatment follow-up visit. ]
  4. Objective response rate, clinical benefit rate and progression-free survival based on investigator assessments according to Response Evaluation Criteria in Solid Tumors (RECIST). [ Time Frame: At Baseline, at the end of Cycles 2, 4 and 6, subsequently at the end of every third cycle, at the end-of-treatment, and at the post-treatment follow-up. ]


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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

Inclusion criteria:

1. Female subjects with confirmed locally recurrent or metastatic carcinoma of the breast who have received prior taxane therapy and at least one prior cytotoxic chemotherapy regimen for advanced disease.

Exclusion criteria:

  1. Subjects who have received prior ixabepilone therapy.
  2. Subjects with prior participation in an eribulin clinical study, even if not assigned to eribulin treatment.
  3. Subjects with pre-existing neuropathy Grade greater than or equal to 2.
  4. Subjects with a history of diabetes mellitus Type 1 or 2.
  5. Subjects with bilateral mastectomy which included bilateral axillary lymph node dissection.
  6. Subjects with missing digits required for vibration assessment.
  7. Subjects with any other concurrent diseases or conditions that would be expected to interfere with neuropathy assessments, which may include vitamin deficiency, sequelae of cerebrovascular disease, thyroid insufficiency, lumbar or cervical radiculopathy, or alcoholic or inflammatory neuropathy.

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): NCT00879086


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Locations
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United States, Arizona
Northern AZ Hematology and Oncology Associates
Sedona, Arizona, United States, 86336
United States, California
Healing Hands Oncology and Medical Care
Hawthorne, California, United States, 90250
University of Southern California
Los Angeles, California, United States, 90033
Comprehensive Cancer Center
Palm Springs, California, United States, 92262
United States, Florida
Comprehensive Cancer Care Specialist of Boca
Boca Raton, Florida, United States, 33428
Robert R. Carroll, MD, PA
Gainesville, Florida, United States, 32605
Hematology Oncology Associates
Lake Worth, Florida, United States, 33461
Medical Specialists of the Palm Beaches
Lake Worth, Florida, United States, 33467
Ocala Oncology Center
Ocala, Florida, United States, 34471
Hematology Oncology Associates of Treasure Coast
Port St. Lucie, Florida, United States, 34952
Oncology and Hematology Associates of West Broward
Tamarac, Florida, United States, 33321
United States, Illinois
Hematology Oncology Associates of Illinois
Chicago, Illinois, United States, 60611
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
United States, Indiana
Central Indiana Cancer Centers
Indianapolis, Indiana, United States, 46219
United States, Iowa
Heartland Oncology Hematology
Council Bluffs, Iowa, United States, 51503
United States, Louisiana
Hematology and Oncology Specialists
Marrero, Louisiana, United States, 70072
Metairie Institute of Comprehensive Health
Metairie, Louisiana, United States, 70006
Hematology and Oncology Specialists
New Orleans, Louisiana, United States, 70115
United States, Maryland
Maryland Oncology Hematology, PA
Columbia, Maryland, United States, 21044
Washington County Hospital
Hagerstown, Maryland, United States, 21740
United States, Michigan
Josephine Ford Cancer Center
Brownstown, Michigan, United States, 48183
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, United States, 48126
Henry Ford Health Systems
Detroit, Michigan, United States, 48202
Henry Ford Medical Center Farmington
West Bloomfield, Michigan, United States, 48322
United States, New Jersey
Summit Medical Group
Berkeley Heights, New Jersey, United States, 7922
Joan Knechel Cancer Center
Mt. Arlington, New Jersey, United States, 7856
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10461
Queens Cancer Center of Queens Hospital
Jamaica, New York, United States, 11432
Saint Vincent's Comprehensive Cancer Center
New York, New York, United States, 10011
Weil Cornell Breast Center
New York, New York, United States, 10065
United States, North Carolina
Charleston Hematology Oncology Associates PA
Charleston, North Carolina, United States, 29403
Cancer Center of North Carolina
Raleigh, North Carolina, United States, 27607
United States, Oregon
Northwest Cancer Specialists Rose Quarter
Portland, Oregon, United States, 97227
Northwest Cancer Specialists Hoyt
Portland, Oregon, United States
Northwest Cancer Specialists
Tualatin, Oregon, United States, 97062
United States, Texas
Lone Star Oncology
Austin, Texas, United States, 78759
South Texas Institute of Cancer
Corpus Christi, Texas, United States, 78405
Northwest Cancer Center
Corpus Christi, Texas, United States, 78410
Texas Oncology-Sammons Cancer Center
Dallas, Texas, United States, 75246
Texas Cancer Center at Medical City
Dallas, Texas, United States
Texas Oncology, PA
Dallas, Texas, United States
Texas Oncology, PA Bedford
Houston, Texas, United States, 76033
Texas Oncology, PA
Houston, Texas, United States, 77024
North Texas Regional Cancer Center
Plano, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Utah
Northern Utah Associates
Ogden, Utah, United States, 84403
United States, Virginia
Virginia Oncology Associates
Newport News, Virginia, United States, 23606
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
United States, Washington
Northwest Cancer Specialist Vancouver
Vancouver, Washington, United States, 98684
Northwest Cancer Care Specialists, P.C.
Vancouver, Washington, United States, 98686
Sponsors and Collaborators
Eisai Inc.

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Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00879086     History of Changes
Other Study ID Numbers: E7389-G000-209
First Posted: April 9, 2009    Key Record Dates
Last Update Posted: July 23, 2014
Last Verified: July 2014

Keywords provided by Eisai Inc.:
Breast Cancer
Oncology

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Epothilones
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents