None listed
Conditions
Interventions
Group 1 Type of group
Participants received ixabepilone, 40 mg/m^2, given IV over 3 hours every 21 days until unacceptable toxicity or disease progression
Group name:Group 2 Type of group
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.
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Sex/Gender
Female
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Women aged 18 years and older • Histologic or cytologic diagnosis of endometrial carcinoma • Evidence that the cancer is advanced, recurrent, or metastatic and not curable by local measures, such as surgery or radiation. • Karnofsky performance status >=70 • Measurable or nonmeasurable disease that has progressed since last treatment. • All therapy directed at endometrial cancer must be discontinued 21 days prior to start of treatment, except for hormonal therapy which must be discontinued at least 1 week prior to start of study treatment. Concurrent administration of hormone replacement therapy is allowed. • Prior therapy: Participants must have failed 1 prior platinum-based chemotherapeutic regimen for endometrial cancer. May have received 2 prior chemotherapy regimens if 1 regimen was given for stage I or II disease. May have received any number of prior non-cytotoxic regimens such as monoclonal antibodies, cytokines, signal transduction inhibitors, or hormonal therapy. Previous radiation therapy is allowed.
Exclusion criteria
Exclusion criteria: • Carcinosarcoma (malignant mixed mullerian tumor) • Endometrial leiomyosarcoma and endometrial stromal sarcomas • Participants who received no prior chemotherapy for endometrial cancer or ≥2 prior chemotherapy regimens (exceptions defined in protocol) • Known brain metastases • Receipt of prior ixabepilone therapy • Concurrent active infection requiring antibiotics or other therapy • Concurrent unstable disease or other debilitating illness, such as congestive heart failure, unstable angina, myocardial infarction, or other cardiac disease that could jeopardize participation, within the last 6 months • For participants whose prior therapy did not include an anthracycline and therefore may be randomized to doxorubicin, left ventricular ejection fraction 1.5*upper limit of normal (ULN), except for those with Gilbert´s disease • Aspartate aminotransferase or alanine aminotransferase >2.5*ULN • Serum creatinine >1.5*ULN • Grade ≥2 neuropathy (sensory or motor) • No concurrent therapy (chemotherapy, hormonal, or investigational) directed at endometrial cancer during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name: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. Measure:Overall Survival (OS) Timepoints:Date of randomization to date of death or last date censored to up to approximately 26 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name: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. Measure:Progression-free Survival Timepoints: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 ; Outcome name: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. Measure:Best Overall Response Rate Timepoints:Date of randomization and every 6 weeks to end of treatment (9 cycles, or approximately Day 189) ; Outcome name: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. Re | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Czech Republic, Denmark, France, Greece, Hungary, Italy, Mexico, Norway, Russian Federation, Spain, Sweden, United Kindgdom, United States
Contacts
Public Contactursula noto
BRISTOL MYERS SQUIBB PERU S.A.
Outcome results
None listed