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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00883116
Registration number
NCT00883116
Ethics application status
Date submitted
16/04/2009
Date registered
17/04/2009
Date last updated
9/03/2017
Titles & IDs
Public title
A Study of Ixabepilone as Second-line Therapy for Locally Advanced, Recurrent, or Metastatic Endometrial Cancer
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Scientific title
A Phase III, Open Label, Randomized, 2 Arm Study of Ixabepilone Administered Every 21 Days Versus Paclitaxel or Doxorubicin Administered Every 21 Days in Women With Advanced Endometrial Cancer Who Have Previously Been Treated With Chemotherapy
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Secondary ID [1]
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2008-007167-16
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Secondary ID [2]
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CA163-196
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Universal Trial Number (UTN)
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Trial acronym
IXAMPLE2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Endometrial Cancer
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Condition category
Condition code
Cancer
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Womb (Uterine or endometrial cancer)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Experimental: Ixabepilone, 40 mg/m^2, intravenously (IV) - Participants received ixabepilone, 40 mg/m\^2, given IV over 3 hours every 21 days until unacceptable toxicity or disease progression
Active comparator: Control chemotherapy (Paclitaxel or 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.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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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.
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Timepoint [1]
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Date of randomization to date of death or last date censored to up to approximately 26 months
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Secondary outcome [1]
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Progression-free Survival
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Assessment method [1]
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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.
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Timepoint [1]
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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
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Secondary outcome [2]
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Best Overall Response Rate
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Assessment method [2]
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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.
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Timepoint [2]
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Date of randomization and every 6 weeks to end of treatment (9 cycles, or approximately Day 189)
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Secondary outcome [3]
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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
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Assessment method [3]
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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.
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Timepoint [3]
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From Day 1 (first dose) to 30 days past last dose (up to Day 219); 9 cycles, or 189 days + 30 days
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Eligibility
Key inclusion criteria
Key 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.
* If only disease is confined to a solitary lesion, its neoplastic nature must be confirmed by histology or cytology.
* Disease in a previously irradiated field is acceptable as the only site of measurable disease only if there has been clear progression since completion of radiotherapy.
* 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.
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Minimum age
18
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key 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 <50% as measured by multigated radionuclide angiography or echocardiography
* History of malignancy, except nonmelanoma skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of the breast, within the last 5 years that has not been treated with chemotherapy
* Known human immunodeficiency viral infection
* Psychiatric disorders or other conditions rendering the participant incapable of complying with protocol requirements
* Absolute neutrophil count <1500/mm^3
* Platelets <100,000/mm^3
* Hemoglobin <9 g/dL
* Total bilirubin >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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Intervention assignment
Parallel
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Phase
Phase 3
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2009
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Date of last participant enrolment
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Date of last data collection
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Actual
1/02/2014
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Sample size
Target
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Accrual to date
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Final
551
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Local Institution - Milton
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Local Institution - East Bentleigh
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4064 - Milton
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Recruitment postcode(s) [2]
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3165 - East Bentleigh
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00883116
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Trial related presentations / publications
McMeekin S, Dizon D, Barter J, Scambia G, Manzyuk L, Lisyanskaya A, Oaknin A, Ringuette S, Mukhopadhyay P, Rosenberg J, Vergote I. Phase III randomized trial of second-line ixabepilone versus paclitaxel or doxorubicin in women with advanced endometrial cancer. Gynecol Oncol. 2015 Jul;138(1):18-23. doi: 10.1016/j.ygyno.2015.04.026. Epub 2015 Apr 26.
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00883116
Download to PDF