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A Phase II Evaluation of Ixabepilone (IND #59699, NSC #710428) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus

Phase 2
18 Years
Open (Enrolling)
Recurrent Uterine Sarcoma, Uterine Carcinosarcoma

Thank you

Trial Information

A Phase II Evaluation of Ixabepilone (IND #59699, NSC #710428) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus


I. To determine the response rate of patients with persistent or recurrent carcinosarcoma of
the uterus treated with ixabepilone.

II. To determine the nature and degree of toxicity of this regimen in these patients.


I. To determine the duration of progression-free survival and overall survival of patients
treated with this regimen.


I. To examine the expression of class III beta-tubulin in carcinosarcoma of the uterus.

II. To explore the association between class III beta-tubulin expression with response,
progression-free survival, and overall survival in these patients.

OUTLINE: This is a multicenter study.

Patients receive ixabepilone IV over 3 hours on day 1. Treatment repeats every 21 days in
the absence of disease progression or unacceptable toxicity.

Tumor tissue samples from prior surgery may be collected for class III beta-tubulin analysis
by IHC.

After completion of study therapy, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.

Inclusion Criteria:

- Histologically confirmed uterine carcinosarcoma

- Persistent or recurrent disease refractory to curative or established treatments

- Malignant mixed müllerian tumor

- Homologous or heterologous type

- Progressive disease after local therapy

- Measurable disease defined as ≥ 1 lesion that can be accurately measured in ≥ 1
dimension (longest diameter to be recorded)

- Each lesion must be ≥ 10 mm by CT scan, MRI, or caliper measurement by clinical
exam OR ≥ 20 mm by chest X-ray

- Lymph nodes must be ≥ 15 mm in short axis by CT scan or MRI

- Patient must have ≥ 1 "target lesion" to assess response

- Tumors within a previously irradiated field will be designated as "non-target"
lesions unless progression is documented or a biopsy is obtained to confirm
persistence ≥ 90 days after completion of radiotherapy

- Patient must have had 1 prior chemotherapeutic regimen for management of
carcinosarcoma that may have included chemotherapy, chemotherapy and radiotherapy,
and/or consolidation/maintenance therapy

- Chemotherapy administered in conjunction with primary radiation as a
radio-sensitizer is counted as a systemic chemotherapy regimen

- Patients who have not received a prior taxane therapy (e.g., paclitaxel or
docetaxel) must receive a second regimen that includes a taxane

- Patients must not be eligible for a higher priority GOG or Rare Tumor protocol, if
one exists

- ECOG performance status 0-2

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Creatinine ≤ 1.5 times upper limit of normal (ULN)

- Bilirubin ≤ 1.5 times ULN

- AST and ALT ≤ 3.0 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Peripheral neuropathy (sensory and motor) ≤ grade 1

- No active infection requiring antibiotics except uncomplicated urinary tract

- No history of severe grade 3-4 hypersensitivity reaction to agents containing
Cremophor® EL or its derivatives (e.g., polyoxyethylated castor oil)

- More than 3 years since other invasive malignancy except non-melanoma skin cancer

- No concurrent amifostine or other protective reagents

- Recovered from recent surgery, radiotherapy, or chemotherapy

- At least 1 week since prior hormonal therapy

- At least 3 weeks since any prior therapy directed at the malignant tumor, including
biological and immunological agents

- One prior non-cytotoxic (biologic or cytostatic) regimen for management of recurrent
or persistent disease that includes, but is not limited to, any of the following

- Monoclonal antibodies

- Cytokines

- Small-molecule inhibitors of signal transduction

- More than 3 years since prior radiotherapy to any portion of the abdominal cavity or
pelvis other than for uterine carcinosarcoma

- Prior radiation for localized cancer of the breast, head and neck, or skin
allowed provided the patient remains free of recurrent or metastatic disease

- No prior chemotherapy for any abdominal or pelvic tumor, other than for uterine
carcinosarcoma, within the past 3 years

- More than 3 years since prior adjuvant chemotherapy for localized breast cancer
allowed provided patient has remained free of recurrent or metastatic disease

- No prior ixabepilone

- No prior cancer therapy that contraindicates study treatment

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency of patients with objective tumor response

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Carolyn McCourt

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

September 2010

Completion Date:

Related Keywords:

  • Recurrent Uterine Sarcoma
  • Uterine Carcinosarcoma
  • Carcinosarcoma
  • Mixed Tumor, Mullerian
  • Uterine Neoplasms
  • Sarcoma



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