Ixabepilone in Treating Patients With Recurrent or Persistent Uterine Cancer
Condition: Recurrent Uterine Corpus Sarcoma; Uterine Carcinosarcoma
MeSH terms: Carcinosarcoma; Mixed Tumor, Mullerian; Recurrence
Intervention: Ixabepilone; Laboratory Biomarker Analysis
Intervention description: Given IV; Correlative studies
Intervention MeSH terms: Epothilones; Epothilone B
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying the side effects and how well ixabepilone works in treating
      patients with persistent or recurrent uterine cancer. Drugs used in chemotherapy, such as
      ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the
      cells of by stopping them from dividing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically confirmed uterine carcinosarcoma which is persistent
             or recurrent with documented disease progression after appropriate local therapy;
             acceptable histologic type is defined as carcinosarcoma (malignant mixed muellerian
             tumor), homologous or heterologous type

          -  All patients must have measurable disease; measurable disease is defined by Response
             Evaluation Criteria In Solid Tumors (RECIST) (version 1.1); measurable disease is
             defined as at least one lesion that can be accurately measured in at least one
             dimension (longest diameter to be recorded); each lesion must be >= 10 mm when
             measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper
             measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes
             must be >= 15 mm in short axis when measured by CT or MRI

          -  Patients must have at least one ?target lesion? to be used to assess response on this
             protocol as defined by RECIST version 1.1; 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 at least 90 days following completion of
             radiation therapy

          -  Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG)
             protocol, if one exists; in general, this would refer to any active GOG Phase III or
             Rare Tumor protocol for the same patient population

          -  Patients must have a GOG Performance Status of 0, 1, or 2

          -  Recovery from effects of recent surgery, radiotherapy, or chemotherapy

               -  Patients should be free of active infection requiring antibiotics (with the
                  exception of uncomplicated urinary tract infection [UTI])

               -  Any hormonal therapy directed at the malignant tumor must be discontinued at
                  least one week prior to registration

               -  Any other prior therapy directed at the malignant tumor, including biological and
                  immunologic agents, must be discontinued at least three weeks prior to
                  registration

          -  Patients must have had one prior chemotherapeutic regimen for management of
             carcinosarcoma; initial treatment may include chemotherapy, chemotherapy and radiation
             therapy, and/or consolidation/maintenance therapy; chemotherapy administered in
             conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic
             chemotherapy regimen

          -  Patients who have NOT received prior therapy with a taxane (such as paclitaxel or
             docetaxel) MUST receive a second regimen that includes a taxane

          -  Patients must have NOT received any additional cytotoxic chemotherapy except as noted
             above

          -  Patients are allowed to receive, but are not required to receive, one additional
             non-cytotoxic regimen for management of recurrent or persistent disease according to
             the following definition:

               -  Non-cytotoxic (biologic or cytostatic) agents include (but are not limited to)
                  monoclonal antibodies, cytokines, and small-molecule inhibitors of signal
                  transduction

          -  Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl

          -  Platelets greater than or equal to 100,000/mcl

          -  Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)

          -  Bilirubin less than or equal to 1.5 x ULN

          -  Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and
             serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) less
             than or equal to 3 x ULN

          -  Alkaline phosphatase less than or equal to 2.5 x ULN

          -  Patients must have signed an approved informed consent and authorization permitting
             release of personal health information

        Exclusion Criteria:

          -  Neuropathy (sensory and motor) less than or equal to grade 1

          -  Patients who have met the pre-entry requirements

          -  Patients of childbearing potential must have a negative serum pregnancy test 72 hours
             prior to the study entry and be practicing an effective form of contraception

          -  Patients who have received prior therapy with Ixabepilone

          -  Patients with a known history of severe (Common Terminology Criteria for Adverse
             Events [CTCAE] version [v]4.0) grade 3 or 4 hypersensitivity reaction to agents
             containing Cremophor? EL or its derivatives (eg, polyoxyethylated castor oil)

          -  Patients with other invasive malignancies, with the exception of non-melanoma skin
             cancer, and other specific malignancies, are excluded if there is any evidence of
             other malignancy being present within the last three years; patients are also excluded
             if their previous cancer treatment contraindicates this protocol therapy

          -  Patients who have received prior radiotherapy to any portion of the abdominal cavity
             or pelvis OTHER THAN for the treatment of uterine carcinosarcoma within the last three
             years are excluded; prior radiation for localized cancer of the breast, head and neck,
             or skin is permitted, provided that it was completed more than three years prior to
             registration, and the patient remains free of recurrent or metastatic disease

          -  Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER
             THAN for the treatment of uterine carcinosarcoma within the last three years are
             excluded; patients may have received prior adjuvant chemotherapy for localized breast
             cancer, provided that it was completed more than three years prior to registration,
             and that the patient remains free of recurrent or metastatic disease

          -  Patients who are pregnant or nursing