A Study of Ixabepilone as Second-line Therapy for Locally Advanced, Recurrent, or Metastatic Endometrial Cancer

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

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