Brief Title
A Study of Ixabepilone as Second-line Therapy for Locally Advanced, Recurrent, or Metastatic Endometrial Cancer
Official 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
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Overall Survival (OS)
Secondary Outcome
Progression-free Survival
Condition
Endometrial Cancer
Intervention
Ixabepilone
Study Arms / Comparison Groups
Ixabepilone, 40 mg/m^2, intravenously (IV)
Description: Participants received ixabepilone, 40 mg/m^2, given IV over 3 hours every 21 days until unacceptable toxicity or disease progression
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
551
Start Date
August 2009
Completion Date
February 2014
Primary Completion Date
June 2012
Eligibility 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.
Key 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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Bristol-Myers Squibb, ,
Location Countries
Argentina
Location Countries
Argentina
Administrative Informations
NCT ID
NCT00883116
Organization ID
CA163-196
Secondary IDs
2008-007167-16
Responsible Party
Sponsor
Study Sponsor
R-Pharm
Study Sponsor
Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb
Verification Date
January 2017