Phase II Trial of Weekly or Every 3-week Ixabepilone for Patients With Metastatic Breast Cancer
- Registration Number
- NCT00593827
- Lead Sponsor
- R-Pharm
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 176
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Ixabepilone ixabepilone 16 mg/m\^2 weekly for 3 weeks followed by 1 week rest Arm 2 Ixabepilone ixabepilone 40 mg/m\^2 every 3 weeks
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) at 6 Months (6-month PFS Rate): Proportion of Participants Progression Free at 6 Months 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.
- Secondary Outcome Measures
Name Time Method Best Response as Assessed With RECIST 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.
Time to Response 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.Incidence of All Grades of Peripheral Neuropathy 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.
Duration of Response 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.
Median Progression Free Survival 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] 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.Overall Survival (OS) 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
Trial Locations
- Locations (51)
Texas Oncology Sammons Cancer Center
🇺🇸Dallas, Texas, United States
Central Indiana Cancer Centers
🇺🇸Carmel, Indiana, United States
Minnesota Oncology Hematology, P.A.
🇺🇸Minneapolis, Minnesota, United States
Comprehensive Cancer Center Of Nevada
🇺🇸Henderson, Nevada, United States
New Mexico Cancer Care Associates
🇺🇸Santa Fe, New Mexico, United States
Texas Oncology
🇺🇸Houston, Texas, United States
Tyler Cancer Center
🇺🇸Tyler, Texas, United States
Birmingham Hematology & Oncology Associates Llc
🇺🇸Birmingham, Alabama, United States
Southwest Cancer Care
🇺🇸Murrieta, California, United States
Missouri Cancer Associates
🇺🇸Columbia, Missouri, United States
Arch Medical Services, Inc.
🇺🇸St. Louis, Missouri, United States
Cancer Care & Hematology Specialists Of Chicagoland
🇺🇸Niles, Illinois, United States
Hope Center
🇺🇸Terre Haute, Indiana, United States
Kansas City Cancer Center, Llc
🇺🇸Kansas City, Missouri, United States
New York Oncology Hematology, P.C.
🇺🇸Amsterdam, New York, United States
Raleigh Hematology Oncology Associates
🇺🇸Raleigh, North Carolina, United States
Interlakes Oncology & Hematology, P.C.
🇺🇸Rochester, New York, United States
Regional Cancer Care
🇺🇸Durham, North Carolina, United States
Texas Cancer Center
🇺🇸Denton, Texas, United States
Texas Oncology-Central Austin Cancer Center
🇺🇸Austin, Texas, United States
Texas Cancer Center At Medical City
🇺🇸Dallas, Texas, United States
Texas Oncology/Methodist Charlton Cancer Ctr
🇺🇸Dallas, Texas, United States
Mamie Mcfaddin Ward Cancer Center Texas Oncology
🇺🇸Beaumont, Texas, United States
Baylor Sammons Cancer Ctr
🇺🇸Dallas, Texas, United States
Texas Oncology - Lake Vista Cancer Center
🇺🇸Lewisville, Texas, United States
Longview Cancer Center
🇺🇸Longview, Texas, United States
South Texas Cancer Center
🇺🇸Mcallen, Texas, United States
Texas Cancer Center Of Mesquite
🇺🇸Mesquite, Texas, United States
Paris Regional Cancer Center Lab
🇺🇸Paris, Texas, United States
Texas Oncology - Odessa
🇺🇸Odessa, Texas, United States
Texas Cancer Center - Sherman
🇺🇸Sherman, Texas, United States
Texas Oncology Cancer Center - Sugar Land
🇺🇸Sugar Land, Texas, United States
Texas Oncology Cancer Care And Research Center
🇺🇸Waco, Texas, United States
Deke Slayton Cancer Center
🇺🇸Webster, Texas, United States
Puget Sound Cancer Centers
🇺🇸Seattle, Washington, United States
Oncology & Hematology Associates Of Southwest Virginia, Inc.
🇺🇸Salem, Virginia, United States
Cancer Care Northwest
🇺🇸Spokane, Washington, United States
Evergreen Hematology And Oncology
🇺🇸Spokane, Washington, United States
Northwest Cancer Specialists, Pc
🇺🇸Vancouver, Washington, United States
Yakima Valley Memorial Hospital/North Star Lodge
🇺🇸Yakima, Washington, United States
Maryland Oncology Hematology, P.A.
🇺🇸Columbia, Maryland, United States
Hematology Oncology Associates
🇺🇸Phoenix, Arizona, United States
Ocala Oncology Center
🇺🇸Ocala, Florida, United States
Cancer Centers Of Florida, P.A
🇺🇸Ocoee, Florida, United States
Hematology-Oncology Assoc. Of Northern Nj, Pa
🇺🇸Morristown, New Jersey, United States
Arizona Oncology Associates D.B.A. Hematology Oncology
🇺🇸Tucson, Arizona, United States
Cancer Centers Of The Carolinas
🇺🇸Greenville, South Carolina, United States
Northern Arizona Hematology & Oncology Associates
🇺🇸Sedona, Arizona, United States
Florida Cancer Institute
🇺🇸Hudson, Florida, United States
Alliance Hematology Oncology, Pa
🇺🇸Westminster, Maryland, United States
Texas Oncology, Pa
🇺🇸Midland, Texas, United States