A Study of Ixabepilone as Second-line Therapy for Locally Advanced, Recurrent, or Metastatic Endometrial Cancer
- Conditions
- Endometrial Cancer
- Interventions
- Registration Number
- NCT00883116
- Lead Sponsor
- R-Pharm
- Brief Summary
The primary purpose of this study is to investigate whether administration of ixabepilone results in superior outcome as assessed by overall survival compared with that achieved with standard chemotherapy (paclitaxel or doxorubicin) in women with advanced endometrial cancer that has progressed following first-line chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 551
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ixabepilone, 40 mg/m^2, intravenously (IV) Ixabepilone Participants received ixabepilone, 40 mg/m\^2, given IV over 3 hours every 21 days until unacceptable toxicity or disease progression Control chemotherapy (Paclitaxel or Doxorubicin) Paclitaxel Participants received either paclitaxel, 175 mg/m\^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m\^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m\^2. Control chemotherapy (Paclitaxel or Doxorubicin) Doxorubicin Participants received either paclitaxel, 175 mg/m\^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m\^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m\^2.
- Primary Outcome Measures
Name Time Method Overall Survival (OS) Date of randomization to date of death or last date censored to up to approximately 26 months Survival was defined as the time from the date of randomization until the date of death. If the patient did not die, OS was censored on the last date he or she was known to be alive.
- Secondary Outcome Measures
Name Time Method Progression-free Survival Date of randomization to date of disease progression or death (or date of last tumor assessment for those who did not die or progress) up to approximately 22 months Progression-free survival was defined as the time from randomization to the date of documented disease progression. Patients who died without a reported prior progression were considered to have progressed on the date of their death. Those who did not progress or die were censored on the date of their last tumor assessment. Participants who did not have any on-study tumor assessments were censored on the date they were randomized. Measurable disease was present if the patient had 1 or more measurable lesions.
Best Overall Response Rate Date of randomization and every 6 weeks to end of treatment (9 cycles, or approximately Day 189) Best overall response rate was defined as the number of participants whose best response was either partial response (PR) or complete response (CR) divided by the number of participants in the treatment group. Overall tumor response was based on an integration of the evaluation of target, nontarget, and new lesions. CR=Disappearance of all clinical and radiologic evidence of target lesions. PR=At least 30% reduction in the sum of diameters of all target lesions; taking as reference the baseline study measurement. Changes in tumor measurements need not be confirmed by repeat measurements performed after the criteria for response were first met.
Number of Participants With a Serious Adverse Event (SAE), an SAE Related to Study Drug, Death as Outcome, a Peripheral Neuropathy Adverse Event (AE), a Grade 3 or Higher AE, and an AE Related to Study Drug From Day 1 (first dose) to 30 days past last dose (up to Day 219); 9 cycles, or 189 days + 30 days AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related to study drug=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
Trial Locations
- Locations (29)
Pennsylvania Oncology Hematology Associates
🇺🇸Philadelphia, Pennsylvania, United States
University Of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Sparrow Regional Cancer Center
🇺🇸Lansing, Michigan, United States
Sudarshan K. Sharma, Md
🇺🇸Hinsdale, Illinois, United States
Sarasota Memorial Health Care System
🇺🇸Sarasota, Florida, United States
Blumenthal Cancer Center
🇺🇸Charlotte, North Carolina, United States
Women'S Health Specialists
🇺🇸Rockville, Maryland, United States
University Of Virginia
🇺🇸Charlottesville, Virginia, United States
Hematology Oncology, P.C.
🇺🇸Stamford, Connecticut, United States
Women & Infants Hospital Of Ri
🇺🇸Providence, Rhode Island, United States
Gynecologic Oncology Assoc.,Inc
🇺🇸Hollywood, Florida, United States
Cancer Centers Of The Carolinas
🇺🇸Greenville, South Carolina, United States
Rocky Mountain Gynecologic Oncology
🇺🇸Englewood, Colorado, United States
Peggy And Charles Stephenson Oklahoma Cancer Center
🇺🇸Oklahoma City, Oklahoma, United States
Georgia Health Science University
🇺🇸Augusta, Georgia, United States
Local Institution
🇬🇧Leeds, Yorkshire, United Kingdom
Tennessee Gynecologic Oncology Group, Llc
🇺🇸Chattanooga, Tennessee, United States
St. Vincent Hospital And Health Care Center, Inc.
🇺🇸Indianapolis, Indiana, United States
University Of South Alabama
🇺🇸Mobile, Alabama, United States
Central Dupage Hospital Cancer Center
🇺🇸Warrenville, Illinois, United States
Hematology And Oncology Specialists, Llc
🇺🇸Marrero, Louisiana, United States
Magee-Womens Hospital Of Upmc Laboratory
🇺🇸Pittsburgh, Pennsylvania, United States
Tulsa Cancer Institute
🇺🇸Tulsa, Oklahoma, United States
Saint Dominic's Gynecologic Oncology
🇺🇸Jackson, Mississippi, United States
Matthew A Powell, Md
🇺🇸Saint Louis, Missouri, United States
Peter E. Schwartz, Md
🇺🇸New Haven, Connecticut, United States
Florida Hospital Cancer Institute
🇺🇸Orlando, Florida, United States
H. Lee Moffitt Cancer Center
🇺🇸Tampa, Florida, United States