A Study of Ixabepilone as Second Line Therapy for Locally Advanced, Recurrent or Metastatic Endometrial Cancer (IXAMPLE2)


Tracking Information

Start Date  ICMJEAugust 2009
Estimated Primary Completion DateJuly 2012   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2009)		Evidence of improved progression-free survival (PFS) with ixabepilone versus control chemotherapy (paclitaxel or doxorubicin) as confirmed by an Independent Radiologic Review Committee (IRRC) [ Time Frame: 34 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00883116 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: April 16, 2009)
  • Comparison of overall survival (OS) between ixabepilone and control chemotherapy [ Time Frame: 53 months ] [ Designated as safety issue: No ]
  • Comparison of Objective response rate (ORR) between ixabepilone and control chemotherapy [ Time Frame: 53 months ] [ Designated as safety issue: No ]
  • Compare PFS in all randomized subjects between ixabepilone and control chemotherapy [ Time Frame: 53 months ] [ Designated as safety issue: No ]
  • Compare duration of response and time to response of ixabepilone versus control chemotherapy, in responding subjects with measurable disease [ Time Frame: 53 months ] [ Designated as safety issue: No ]
  • Evaluate the toxicity profiles of ixabepilone and control chemotherapy [ Time Frame: 53 months ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Study of Ixabepilone as Second Line Therapy for Locally Advanced, Recurrent or Metastatic Endometrial Cancer
Official Title  ICMJEA 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 measured by progression free survival (PFS) compared to standard chemotherapy (Paclitaxel or Doxorubicin) in women with advanced endometrial cancer that progressed after first line chemotherapy.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEEndometrial Cancer
Intervention  ICMJE
  • Drug: Ixabepilone
    Injection, IV, 40 mg/m², Once every 21 days, Until progression or unacceptable toxicity
    Other Names:
    • Ixempra
    • BMS-247550
  • Drug: Doxorubicin
    Injection, IV injection, 60 mg/m², Once every 21 days, Until progression, unacceptable toxicity or cumulative dose of 500 mg/m²
    Other Names:
    • Adriamycin PFS/RDF
    • Adriacin
    • Adriblastina
    • Adriablastine
    • Adrimedac
    • DOXO-CELL
    • Doxolem
    • Doxorubin
    • Farmiblastina
    • Rubex
  • Drug: Paclitaxel
    Injection, IV, 175 mg/m², Once every 21 days, Until progression or unacceptable toxicity
    Other Names:
    • Taxol
    • Anzatax
    • Asotax
    • Bristaxol Praxel
    • Taxol Konzentrat
    • F1-106
Study Arms / Comparison Groups
  • Ixabepilone: Experimental
    Intervention: Drug: Ixabepilone
  • Control Chemotherapy: Active Comparator
    Doxorubicin or Paclitaxel
    Interventions:
    • Drug: Doxorubicin
    • Drug: Paclitaxel

Recruitment Information

Estimated Enrollment  ICMJE370
Estimated Completion DateMarch 2014
Estimated Primary Completion DateJuly 2012   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed endometrial cancer, locally advanced, recurrent or metastatic
  • Karnofsky performance status (KPS) ≥ 70
  • Measurable or non-measurable disease that has progressed since last treatment
  • Receipt of only one prior chemotherapy, as first-line therapy for advanced endometrial cancer
  • Women, ages 18 to older

Exclusion Criteria:

  • Carcinosarcoma (malignant mixed mullerian tumor), endometrial leiomyosarcoma and endometrial stromal sarcomas
  • No prior first-line chemotherapy or receipt of ≥ 2 prior chemotherapy regimens for locally advanced, recurrent or metastatic endometrial cancer
  • Known brain metastases
  • Prior ixabepilone therapy
  • Concurrent active infection requiring antibiotics or other therapy
  • Concurrent unstable disease or illness that could jeopardize participation in study
  • Impaired cardiac function with LVEF of < 50% as measured by MUGA or ECHO
  • Malignancy within last 5 years except non-melanoma skin cancer, carcinoma in situ of the cervix, or of the breast not treated with chemotherapy
  • Grade ≥ 2 neuropathy (sensory or motor)
  • Inadequate hematologic, renal and hepatic function
GenderFemale
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.
Location Countries  ICMJEUnited States,   Argentina,   Australia,   Belgium,   Brazil,   Canada,   Czech Republic,   Denmark,   Finland,   France,   Greece,   Hungary,   Italy,   Mexico,   Norway,   Peru,   Poland,   Russian Federation,   Spain,   Sweden,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00883116
Responsible PartyStudy Director, Bristol-Myers Squibb
Study ID Numbers  ICMJECA163-196, 2008-007167-16
Study Sponsor  ICMJEBristol-Myers Squibb
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Bristol-Myers SquibbBristol-Myers Squibb
Information Provided ByBristol-Myers Squibb