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

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.

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

Conditions

• Endometrial cancer

Study Type

Interventional

Study Design

Treatment, Randomised, Open Label, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary outcome measures

• 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 ]

Secondary outcome measures

• 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 randomised 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 ]

Study arms and assigned interventions

1. Ixabepilone: Experimental:
   • Drug: Ixabepilone Injection, IV, 40 mg/m², Once every 21 days, Until progression or unacceptable toxicity
2. Control Chemotherapy: Active Comparator Doxorubicin or Paclitaxel:
   • Drug: Doxorubicin Injection, IV injection, 60 mg/m², Once every 21 days, Until progression, unacceptable toxicity or cumulative dose of 500 mg/m²
   • Drug: Paclitaxel Injection, IV, 175 mg/m², Once every 21 days, Until progression or unacceptable toxicity

Study Start

August 2009 – February 2014

Eligibility & Criteria

• Ages eligible for study: 18 years and older
• Genders eligible for study: Female
• Accepts healthy volunteers: No

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.

Total Enrolment

370

Contact Details