Clinical trial NCT00879086: A Study Comparing Eribulin Mesylate and Ixabepilone in Causing or Exacerbating Neuropathy in Participants With Advanced Breast Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Breast Cancer
Oncology
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2009-04-09
Enrollment: 104
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants With Treatment-Emergent Neuropathy Adverse Events (AEs)
timeFrame: From administration of first dose up to approximately 5 years
Secondary outcomes:
measure: Percentage of Participants With an Incidence of Treatment-emergent Myalgia/Arthralgia
timeFrame: From administration of first dose up to approximately 5 years
measure: Change From Baseline in Vibration Perception Threshold (VPT)
timeFrame: Baseline, Treatment Phase: Cycles 2 to 6 (Day 1); Extension Phase: Cycle 9 Day 1, Cycle 12 Day 1, Cycle 15 Day 1 (Each Cycle length=21 days), End of Treatment, Post-treatment Follow-up, Worst Post-baseline result (Up to approximately 5 years)
measure: Number of Participants With Shift From Baseline to Worst Post-baseline Participant Neurotoxicity Questionnaire (PNQ) Score for Item 1 (Sensory)
timeFrame: Baseline up to approximately 5 years
measure: Number of Participants With Shift From Baseline to Worst Post-baseline Participant Neurotoxicity Questionnaire (PNQ) Score for Item 2 (Motor)
timeFrame: Baseline up to approximately 5 years
measure: Number of Participants With Shift From Baseline to Worst Post-baseline Participant Neurotoxicity Questionnaire (PNQ) Composite Score
timeFrame: Baseline up to approximately 5 years
measure: Objective Response Rate (ORR)
timeFrame: From date of treatment start until disease progression (PD) (Up to approximately 5 years)
measure: Progression-Free Survival (PFS)
timeFrame: From date of treatment start until the date of PD or death from any cause (Up to approximately 5 years)
measure: Clinical Benefit Rate (CBR)
timeFrame: From date of treatment start until PD or death from any cause, whichever occurred first (Up to approximately 5 years)
measure: Duration of Response (DoR)
timeFrame: From date of first CR or PR until the first documentation of PD or date of death (Up to approximately 5 years)
measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Eribulin and Ixabepilone
timeFrame: For each participant, from the first dose till 42 days after the last dose of study treatment (Up to approximately 5 years)
Other outcomes:
Locations:
city: Sedona
country: United States
facility: Northern AZ Hematology and Oncology Associates
state: Arizona
city: Hawthorne
country: United States
facility: Healing Hands Oncology and Medical Care
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Palm Springs
country: United States
facility: Comprehensive Cancer Center
state: California
city: Boca Raton
country: United States
facility: Comprehensive Cancer Care Specialist of Boca
state: Florida
city: Gainesville
country: United States
facility: Robert R. Carroll, MD, PA
state: Florida
city: Lake Worth
country: United States
facility: Hematology Oncology Associates
state: Florida
city: Lake Worth
country: United States
facility: Medical Specialists of the Palm Beaches
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Port Saint Lucie
country: United States
facility: Hematology Oncology Associates of Treasure Coast
state: Florida
city: Tamarac
country: United States
facility: Oncology and Hematology Associates of West Broward
state: Florida
city: Chicago
country: United States
facility: Hematology Oncology Associates of Illinois
state: Illinois
city: Decatur
country: United States
facility: Decatur Memorial Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Central Indiana Cancer Centers
state: Indiana
city: Council Bluffs
country: United States
facility: Heartland Oncology Hematology
state: Iowa
city: Marrero
country: United States
facility: Hematology and Oncology Specialists
state: Louisiana
city: Metairie
country: United States
facility: Metairie Institute of Comprehensive Health
state: Louisiana
city: New Orleans
country: United States
facility: Hematology and Oncology Specialists
state: Louisiana
city: Columbia
country: United States
facility: Maryland Oncology Hematology, PA
state: Maryland
city: Hagerstown
country: United States
facility: Washington County Hospital
state: Maryland
city: Brownstown
country: United States
facility: Josephine Ford Cancer Center
state: Michigan
city: Dearborn
country: United States
facility: Henry Ford Medical Center-Fairlane
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health Systems
state: Michigan
city: West Bloomfield
country: United States
facility: Henry Ford Medical Center Farmington
state: Michigan
city: Berkeley Heights
country: United States
facility: Summit Medical Group
state: New Jersey
city: Mount Arlington
country: United States
facility: Joan Knechel Cancer Center
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Jamaica
country: United States
facility: Queens Cancer Center of Queens Hospital
state: New York
city: New York
country: United States
facility: Saint Vincent's Comprehensive Cancer Center
state: New York
city: New York
country: United States
facility: Weil Cornell Breast Center
state: New York
city: Charleston
country: United States
facility: Charleston Hematology Oncology Associates PA
state: North Carolina
city: Raleigh
country: United States
facility: Cancer Center of North Carolina
state: North Carolina
city: Portland
country: United States
facility: Northwest Cancer Specialists Rose Quarter
state: Oregon
city: Portland
country: United States
facility: Northwest Cancer Specialists Hoyt
state: Oregon
city: Tualatin
country: United States
facility: Northwest Cancer Specialists
state: Oregon
city: Austin
country: United States
facility: Lone Star Oncology
state: Texas
city: Corpus Christi
country: United States
facility: South Texas Institute of Cancer
state: Texas
city: Corpus Christi
country: United States
facility: Northwest Cancer Center
state: Texas
city: Dallas
country: United States
facility: Texas Oncology-Sammons Cancer Center
state: Texas
city: Dallas
country: United States
facility: Texas Cancer Center at Medical City
state: Texas
city: Dallas
country: United States
facility: Texas Oncology, PA
state: Texas
city: Houston
country: United States
facility: Texas Oncology, PA Bedford
state: Texas
city: Houston
country: United States
facility: Texas Oncology, PA
state: Texas
city: Plano
country: United States
facility: North Texas Regional Cancer Center
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Ogden
country: United States
facility: Northern Utah Associates
state: Utah
city: Newport News
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Vancouver
country: United States
facility: Northwest Cancer Specialist Vancouver
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Care Specialists, P.C.
state: Washington
Study officials:
References: