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A Study of Ixabepilone as Second Line Therapy for Locally Advanced, Recurrent or Metastatic Endometrial Cancer
Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase III | Treatment | Approved-not yet active | 18 and over | CA163-196
2008-007167-16, NCT00883116 |
Trial Description
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. Eligibility Criteria 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
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
- 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
Trial Contact Information
Trial Lead Organizations/Sponsors Bristol-Myers Squibb Company - New York | Bristol-Myers Squibb | | Study Director |
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00883116
Information obtained from ClinicalTrials.gov on April 17, 2009 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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