Clinical trial NCT00593827: Phase II Trial of Weekly or Every 3-week Ixabepilone for Patients With Metastatic Breast Cancer
Official title: Phase II Randomized Trial of Weekly and Every 3-week Ixabepilone in Metastatic Breast Cancer (MBC) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Lead sponsor: R-Pharm
Sponsor class: INDUSTRY
Collaborators: name: US Oncology Research
First posted: 2008-01-15
Enrollment: 176
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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression-Free Survival (PFS) at 6 Months (6-month PFS Rate): Proportion of Participants Progression Free at 6 Months
timeFrame: From the date of randomization to 6-months on study
Secondary outcomes:
measure: Median Progression Free Survival
timeFrame: From the date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 25.7 months)
measure: Overall Response Rate (ORR) Based on Response Criteria in Solid Tumors [RECIST]
timeFrame: Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months)
measure: Best Response as Assessed With RECIST
timeFrame: Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months)
measure: Overall Survival (OS)
timeFrame: From the date of randomization to date of death (maximum participant OS of 26.3 months)
measure: Time to Response
timeFrame: From the date of first dose to date of first PR or CR assessment ( maximum participant time to response of 8.3 months)
measure: Duration of Response
timeFrame: 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)
measure: Incidence of All Grades of Peripheral Neuropathy
timeFrame: 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 outcomes:
measure: 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
timeFrame: 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).
Locations:
city: Birmingham
country: United States
facility: Birmingham Hematology & Oncology Associates Llc
state: Alabama
city: Phoenix
country: United States
facility: Hematology Oncology Associates
state: Arizona
city: Sedona
country: United States
facility: Northern Arizona Hematology & Oncology Associates
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates D.B.A. Hematology Oncology
state: Arizona
city: Murrieta
country: United States
facility: Southwest Cancer Care
state: California
city: Hudson
country: United States
facility: Florida Cancer Institute
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Ocoee
country: United States
facility: Cancer Centers Of Florida, P.A
state: Florida
city: Niles
country: United States
facility: Cancer Care & Hematology Specialists Of Chicagoland
state: Illinois
city: Carmel
country: United States
facility: Central Indiana Cancer Centers
state: Indiana
city: Terre Haute
country: United States
facility: Hope Center
state: Indiana
city: Columbia
country: United States
facility: Maryland Oncology Hematology, P.A.
state: Maryland
city: Westminster
country: United States
facility: Alliance Hematology Oncology, Pa
state: Maryland
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Columbia
country: United States
facility: Missouri Cancer Associates
state: Missouri
city: Kansas City
country: United States
facility: Kansas City Cancer Center, Llc
state: Missouri
city: St. Louis
country: United States
facility: Arch Medical Services, Inc.
state: Missouri
city: Henderson
country: United States
facility: Comprehensive Cancer Center Of Nevada
state: Nevada
city: Morristown
country: United States
facility: Hematology-Oncology Assoc. Of Northern Nj, Pa
state: New Jersey
city: Santa Fe
country: United States
facility: New Mexico Cancer Care Associates
state: New Mexico
city: Amsterdam
country: United States
facility: New York Oncology Hematology, P.C.
state: New York
city: Rochester
country: United States
facility: Interlakes Oncology & Hematology, P.C.
state: New York
city: Durham
country: United States
facility: Regional Cancer Care
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Hematology Oncology Associates
state: North Carolina
city: Greenville
country: United States
facility: Cancer Centers Of The Carolinas
state: South Carolina
city: Arlington
country: United States
facility: Texas Cancer Center
state: Texas
city: Austin
country: United States
facility: Texas Oncology-Central Austin Cancer Center
state: Texas
city: Beaumont
country: United States
facility: Mamie Mcfaddin Ward Cancer Center Texas Oncology
state: Texas
city: Bedord
country: United States
facility: Texas Oncology
state: Texas
city: Dallas
country: United States
facility: Texas Cancer Center At Medical City
state: Texas
city: Dallas
country: United States
facility: Texas Oncology
state: Texas
city: Dallas
country: United States
facility: Texas Oncology/Methodist Charlton Cancer Ctr
state: Texas
city: Dallas
country: United States
facility: Baylor Sammons Cancer Ctr
state: Texas
city: Dallas
country: United States
facility: Texas Oncology Sammons Cancer Center
state: Texas
city: Denton
country: United States
facility: Texas Cancer Center
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology
state: Texas
city: Garland
country: United States
facility: Texas Oncology
state: Texas
city: Houston
country: United States
facility: Texas Oncology
state: Texas
city: Lewisville
country: United States
facility: Texas Oncology - Lake Vista Cancer Center
state: Texas
city: Longview
country: United States
facility: Longview Cancer Center
state: Texas
city: Mcallen
country: United States
facility: South Texas Cancer Center
state: Texas
city: Mesquite
country: United States
facility: Texas Cancer Center Of Mesquite
state: Texas
city: Midland
country: United States
facility: Texas Oncology, Pa
state: Texas
city: Odessa
country: United States
facility: Texas Oncology - Odessa
state: Texas
city: Paris
country: United States
facility: Paris Regional Cancer Center Lab
state: Texas
city: Sherman
country: United States
facility: Texas Cancer Center - Sherman
state: Texas
city: Sugar Land
country: United States
facility: Texas Oncology Cancer Center - Sugar Land
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Waco
country: United States
facility: Texas Oncology Cancer Care And Research Center
state: Texas
city: Webster
country: United States
facility: Deke Slayton Cancer Center
state: Texas
city: Salem
country: United States
facility: Oncology & Hematology Associates Of Southwest Virginia, Inc.
state: Virginia
city: Edmonds
country: United States
facility: Puget Sound Cancer Centers
state: Washington
city: Seattle
country: United States
facility: Puget Sound Cancer Centers
state: Washington
city: Spokane
country: United States
facility: Cancer Care Northwest
state: Washington
city: Spokane
country: United States
facility: Evergreen Hematology And Oncology
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists, Pc
state: Washington
city: Yakima
country: United States
facility: Yakima Valley Memorial Hospital/North Star Lodge
state: Washington
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: