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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


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Endometrial Cancer

Thank you

Trial Information

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


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 prior platinum based chemotherapy regimen for advanced endometrial cancer

- Subjects may have received 2 prior chemotherapy (ie. cytotoxic) regimens if 1 regimen
was given for Stage I or II disease

- 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 except
as defined in the Inclusion Criteria

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evidence of improved overall survival (OS) with ixabepilone versus control chemotherapy (paclitaxel or doxorubicin) as reported per Investigator

Outcome Time Frame:

Upon death for each patient

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Study ID:

CA163-196

NCT ID:

NCT00883116

Start Date:

August 2009

Completion Date:

May 2013

Related Keywords:

  • Endometrial Cancer
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

Name

Location

University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Cedars-Sinai Medical Center Los Angeles, California  90048
Florida Gynecologic Oncology Fort Myers, Florida  33901
Virginia Commonwealth University Richmond, Virginia  
University Of Rochester Gynecologic Oncology Rochester, New York  14620