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.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Local Institution, La Rioja 5300, Argentina
Local Institution, Salta A4406CLA, Argentina
Local Institution, Gent 9000, Belgium
Local Institution, Leuven B-3000, Belgium
Local Institution, Sao Paulo 01246-000, Brazil
Local Institution, Brno 656 53, Czech Republic
Local Institution, Hradec Kralove 500 05, Czech Republic
Local Institution, Copenhagen 2100, Denmark
Local Institution, Herlev 2730, Denmark
Local Institution, Odense C 5000, Denmark
Local Institution, Paris 75004, France
Local Institution, Poitiers 86000, France
Local Institution, Saint Herblain Cedex 44805, France
Local Institution, Villejuif Cedex 94800, France
Local Institution, Athens 11528, Greece
Local Institution, Budapest 1122, Hungary
Local Institution, Miskolc H-3526, Hungary
Local Institution, Brescia 25123, Italy
Local Institution, Campobasso 86100, Italy
Local Institution, Meldola (fc) 47014, Italy
Local Institution, Milano 20141, Italy
Local Institution, Monza 20052, Italy
Local Institution, Roma 00168, Italy
Local Institution, Bergen 5021, Norway
Local Institution, Oslo 0310, Norway
Local Institution, Lima Lima 11, Peru
Local Institution, Lima LIMA 13, Peru
Local Institution, Lima 34, Peru
Local Institution, Ivanovo 153013, Russian Federation
Local Institution, Moscow 115 478, Russian Federation
Local Institution, Moscow 117997, Russian Federation
Local Institution, Obninsk 249036, Russian Federation
Local Institution, St Pertersburg 198255, Russian Federation
Local Institution, St Petersburg 197758, Russian Federation
Local Institution, Barcelona 08035, Spain
Local Institution, Madrid 28040, Spain
Local Institution, Valencia 46009, Spain
Local Institution, Goteborg 413 45, Sweden
Local Institution, Linkoping 581 85, Sweden
Local Institution, Stockholm 171 76, Sweden
Local Institution, Umea 901 85, Sweden
Local Institution, Uppsala 751 85, Sweden
University Of South Alabama, Mobile, Alabama 36604, United States
Local Institution, Calgary, Alberta T2N 4N2, Canada
Local Institution, Bristol, Avon BS2 8ED, United Kingdom
Local Institution, Surrey, British Columbia V3V 1Z2, Canada
Local Institution, Vancouver, British Columbia V5Z 4E6, Canada
Rocky Mountain Gynecologic Oncology, Englewood, Colorado 80113, United States
Peter E. Schwartz, Md, New Haven, Connecticut 06510-3206, United States
Hematology Oncology, P.C., Stamford, Connecticut 06902, United States
Local Institution, Df, Distrito Federal 06720, Mexico
Local Institution, Mexico City, Distrito Federal 06726, Mexico
Local Institution, Mexico, Distrito Federal 07760, Mexico
Local Institution, Monterrey, Distrito Federal 64320, Mexico
Local Institution, Tlalpan, Distrito Federal 14080, Mexico
Local Institution, Glasgow, Dumfries & Galloway G12 0YN, United Kingdom
Gynecologic Oncology Assoc.,Inc, Hollywood, Florida 33021, United States
Florida Hospital Cancer Institute, Orlando, Florida 32804, United States
Sarasota Memorial Health Care System, Sarasota, Florida 34239, United States
H. Lee Moffitt Cancer Center, Tampa, Florida 33612, United States
Georgia Health Science University, Augusta, Georgia 30912-3335, United States
Sudarshan K. Sharma, Md, Hinsdale, Illinois 60521, United States
Central Dupage Hospital Cancer Center, Warrenville, Illinois 60555, United States
St. Vincent Hospital And Health Care Center, Inc., Indianapolis, Indiana 46260, United States
Local Institution, Guadalajara, Jalisco 44340, Mexico
Hematology And Oncology Specialists, Llc, Marrero, Louisiana 70072, United States
Women'S Health Specialists, Rockville, Maryland 20852, United States
Sparrow Regional Cancer Center, Lansing, Michigan 48912, United States
University Of Minnesota, Minneapolis, Minnesota 55455-0374, United States
Saint Dominic's Gynecologic Oncology, Jackson, Mississippi 39216, United States
Matthew A Powell, Md, Saint Louis, Missouri 63110, United States
Blumenthal Cancer Center, Charlotte, North Carolina 28204, United States
Duke University Medical Center, Durham, North Carolina 27710, United States
Local Institution, Nottingham, Nottinghamshire NG5 1PB, United Kingdom
Local Institution, Halifax, Nova Scotia B3H 1V7, Canada
Peggy And Charles Stephenson Oklahoma Cancer Center, Oklahoma City, Oklahoma 73104, United States
Tulsa Cancer Institute, Tulsa, Oklahoma 74136, United States
Local Institution, Toronto, Ontario M5G 2M9, Canada
Pennsylvania Oncology Hematology Associates, Philadelphia, Pennsylvania 19106, United States
Magee-Womens Hospital Of Upmc Laboratory, Pittsburgh, Pennsylvania 15213, United States
Local Institution, Fleurimont, Quebec J1H 5N4, Canada
Local Institution, Montreal, Quebec H2L 4M1, Canada
Local Institution, Milton, Queensland 4064, Australia
Women & Infants Hospital Of Ri, Providence, Rhode Island 02908, United States
Local Institution, Porto Alegre, Rio Grande Do Sul 90610-000, Brazil
Local Institution, Rosario, Santa Fe S2000DSK, Argentina
Local Institution, Barretos, Sao Paulo 14784-400, Brazil
Local Institution, Jau, Sao Paulo 17210-120, Brazil
Cancer Centers Of The Carolinas, Greenville, South Carolina 29615, United States
Tennessee Gynecologic Oncology Group, Llc, Chattanooga, Tennessee 37403, United States
Local Institution, East Bentleigh, Victoria 3165, Australia
University Of Virginia, Charlottesville, Virginia 22908, United States
Local Institution, Leeds, Yorkshire LS9 7TF, United Kingdom