A Study of Ixabepilone as Second-line Therapy for Locally Advanced, Recurrent, or Metastatic Endometrial Cancer
Overview[ - collapse ][ - ]
Purpose | 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. |
---|---|
Condition | Endometrial Cancer |
Intervention | Drug: Ixabepilone Drug: Doxorubicin Drug: Paclitaxel |
Phase | Phase 3 |
Sponsor | Bristol-Myers Squibb |
Responsible Party | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier | NCT00883116 |
First Received | April 16, 2009 |
Last Updated | February 12, 2014 |
Last verified | February 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | April 16, 2009 |
---|---|
Last Updated Date | February 12, 2014 |
Start Date | August 2009 |
Estimated Primary Completion Date | December 2013 |
Current Primary Outcome Measures | Overall Survival (OS) [Time Frame: Date of randomization to date of death or last date censored to up to approximately 26 months] [Designated as safety issue: No]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. |
Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
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. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Endometrial Cancer |
Intervention | Drug: Ixabepilone Other Names:
Other Names:
Other Names:
|
Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
---|---|
Estimated Enrollment | 500 |
Estimated Completion Date | December 2013 |
Estimated 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 |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States, Argentina, Australia, Belgium, Brazil, Canada, Czech Republic, Denmark, France, Greece, Hungary, Italy, Mexico, Norway, Peru, Russian Federation, Spain, Sweden, United Kingdom |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00883116 |
---|---|
Other Study ID Numbers | CA163-196 |
Has Data Monitoring Committee | Yes |
Information Provided By | Bristol-Myers Squibb |
Study Sponsor | Bristol-Myers Squibb |
Collaborators | Not Provided |
Investigators | Study Director: Bristol-Myers Squibb Bristol-Myers Squibb |
Verification Date | February 2014 |
Locations[ + expand ][ + ]
University Of South Alabama | Mobile, Alabama, United States, 36604 |
---|---|
Rocky Mountain Gynecologic Oncology | Englewood, Colorado, United States, 80113 |
Peter E. Schwartz, Md | New Haven, Connecticut, United States, 06510-3206 |
Hematology Oncology, P.C. | Stamford, Connecticut, United States, 06902 |
Gynecologic Oncology Assoc.,Inc | Hollywood, Florida, United States, 33021 |
Florida Hospital Cancer Institute | Orlando, Florida, United States, 32804 |
Sarasota Memorial Health Care System | Sarasota, Florida, United States, 34239 |
H. Lee Moffitt Cancer Center | Tampa, Florida, United States, 33612 |
Georgia Health Science University | Augusta, Georgia, United States, 30912-3335 |
Sudarshan K. Sharma, Md | Hinsdale, Illinois, United States, 60521 |
Central Dupage Hospital Cancer Center | Warrenville, Illinois, United States, 60555 |
St. Vincent Hospital And Health Care Center, Inc. | Indianapolis, Indiana, United States, 46260 |
Hematology And Oncology Specialists, Llc | Marrero, Louisiana, United States, 70072 |
Women'S Health Specialists | Rockville, Maryland, United States, 20852 |
Sparrow Regional Cancer Center | Lansing, Michigan, United States, 48912 |
University Of Minnesota | Minneapolis, Minnesota, United States, 55455-0374 |
Saint Dominic's Gynecologic Oncology | Jackson, Mississippi, United States, 39216 |
Matthew A Powell, Md | Saint Louis, Missouri, United States, 63110 |
Blumenthal Cancer Center | Charlotte, North Carolina, United States, 28204 |
Duke University Medical Center | Durham, North Carolina, United States, 27710 |
Peggy And Charles Stephenson Oklahoma Cancer Center | Oklahoma City, Oklahoma, United States, 73104 |
Tulsa Cancer Institute | Tulsa, Oklahoma, United States, 74136 |
Pennsylvania Oncology Hematology Associates | Philadelphia, Pennsylvania, United States, 19106 |
Magee-Womens Hospital Of Upmc Laboratory | Pittsburgh, Pennsylvania, United States, 15213 |
Women & Infants Hospital Of Ri | Providence, Rhode Island, United States, 02908 |
Cancer Centers Of The Carolinas | Greenville, South Carolina, United States, 29615 |
Tennessee Gynecologic Oncology Group, Llc | Chattanooga, Tennessee, United States, 37403 |
University Of Virginia | Charlottesville, Virginia, United States, 22908 |
Local Institution | Rosario, Santa Fe, Argentina, S2000DSK |
Local Institution | La Rioja, Argentina, 5300 |
Local Institution | Salta, Argentina, A4406CLA |
Local Institution | Milton, Queensland, Australia, 4064 |
Local Institution | East Bentleigh, Victoria, Australia, 3165 |
Local Institution | Gent, Belgium, 9000 |
Local Institution | Leuven, Belgium, B-3000 |
Local Institution | Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000 |
Local Institution | Barretos, Sao Paulo, Brazil, 14784-400 |
Local Institution | Jau, Sao Paulo, Brazil, 17210-120 |
Local Institution | Sao Paulo, Brazil, 01246-000 |
Local Institution | Calgary, Alberta, Canada, T2N 4N2 |
Local Institution | Surrey, British Columbia, Canada, V3V 1Z2 |
Local Institution | Vancouver, British Columbia, Canada, V5Z 4E6 |
Local Institution | Halifax, Nova Scotia, Canada, B3H 1V7 |
Local Institution | Toronto, Ontario, Canada, M5G 2M9 |
Local Institution | Fleurimont, Quebec, Canada, J1H 5N4 |
Local Institution | Montreal, Quebec, Canada, H2L 4M1 |
Local Institution | Brno, Czech Republic, 656 53 |
Local Institution | Hradec Kralove, Czech Republic, 500 05 |
Local Institution | Copenhagen, Denmark, 2100 |
Local Institution | Herlev, Denmark, 2730 |
Local Institution | Odense C, Denmark, 5000 |
Local Institution | Paris, France, 75004 |
Local Institution | Poitiers, France, 86000 |
Local Institution | Saint Herblain Cedex, France, 44805 |
Local Institution | Villejuif Cedex, France, 94800 |
Local Institution | Athens, Greece, 11528 |
Local Institution | Budapest, Hungary, 1122 |
Local Institution | Miskolc, Hungary, H-3526 |
Local Institution | Brescia, Italy, 25123 |
Local Institution | Campobasso, Italy, 86100 |
Local Institution | Meldola (fc), Italy, 47014 |
Local Institution | Milano, Italy, 20141 |
Local Institution | Monza, Italy, 20052 |
Local Institution | Roma, Italy, 00168 |
Local Institution | Df, Distrito Federal, Mexico, 06720 |
Local Institution | Mexico, Distrito Federal, Mexico, 07760 |
Local Institution | Mexico City, Distrito Federal, Mexico, 06726 |
Local Institution | Monterrey, Distrito Federal, Mexico, 64320 |
Local Institution | Tlalpan, Distrito Federal, Mexico, 14080 |
Local Institution | Guadalajara, Jalisco, Mexico, 44340 |
Local Institution | Bergen, Norway, 5021 |
Local Institution | Oslo, Norway, 0310 |
Local Institution | Lima, Peru, LIMA 13 |
Local Institution | Lima, Peru, Lima 11 |
Local Institution | Lima, Peru, 34 |
Local Institution | Ivanovo, Russian Federation, 153013 |
Local Institution | Moscow, Russian Federation, 117997 |
Local Institution | Moscow, Russian Federation, 115 478 |
Local Institution | Obninsk, Russian Federation, 249036 |
Local Institution | St Pertersburg, Russian Federation, 198255 |
Local Institution | St Petersburg, Russian Federation, 197758 |
Local Institution | Barcelona, Spain, 08035 |
Local Institution | Madrid, Spain, 28040 |
Local Institution | Valencia, Spain, 46009 |
Local Institution | Goteborg, Sweden, 413 45 |
Local Institution | Linkoping, Sweden, 581 85 |
Local Institution | Stockholm, Sweden, 171 76 |
Local Institution | Umea, Sweden, 901 85 |
Local Institution | Uppsala, Sweden, 751 85 |
Local Institution | Bristol, Avon, United Kingdom, BS2 8ED |
Local Institution | Glasgow, Dumfries & Galloway, United Kingdom, G12 0YN |
Local Institution | Nottingham, Nottinghamshire, United Kingdom, NG5 1PB |
Local Institution | Leeds, Yorkshire, United Kingdom, LS9 7TF |