Ixabepilone in Treating Patients With Recurrent or Persistent Endometrial Cancer
Condition: Endometrial Adenocarcinoma; Recurrent Endometrial Carcinoma; Stage IV Endometrial Carcinoma
MeSH terms: Carcinoma; Endometrial Neoplasms; Recurrence
Intervention: ixabepilone
Intervention description: Given IV
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: 52.0
Sex: Female
Healthy volunteers: No

Summary:

      Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells
      from dividing so they stop growing or die. This phase II trial is studying how well
      ixabepilone works in treating patients with recurrent or persistent endometrial cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed endometrial adenocarcinoma

               -  Recurrent or persistent disease

                    -  Histologic confirmation of the original primary tumor is required

               -  Not amenable to management with any of the following:

                    -  Surgery

                    -  Radiotherapy

                    -  Higher priority or standard chemotherapy

          -  Measurable disease

               -  At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques
                  (e.g., palpation, plain x-ray, CT scan, or MRI) OR ≥ 10 mm by spiral CT scan

          -  At least 1 target lesion

               -  Tumors within a previously irradiated field are designated as non-target lesions

               -  Disease in an irradiated field as the only site of measurable disease is
                  acceptable as a target lesion only if there has been clear progression of the
                  lesion at least 90 days after completion of radiotherapy

          -  Received 1, and only 1, prior chemotherapy regimen (e.g., high-dose therapy,
             consolidation, or extended therapy administered after surgery or non-surgical
             assessment) for management of endometrial adenocarcinoma

          -  Ineligible for a higher priority Gynecologic Oncology Group (GOG) protocol (e.g., any
             active GOG phase III study for the same patient population)

          -  Performance status - GOG 0-2

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  AST (aspartate aminotransferase) ≤ 2.5 times ULN

          -  Alkaline phosphatase ≤ 2.5 times ULN

          -  Creatinine ≤ 1.5 times ULN

          -  Sensory or motor neuropathy ≤ grade 1

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No active infection requiring antibiotics

          -  No other invasive malignancies within the past 5 years except non-melanoma skin cancer

          -  At least 3 weeks since prior biologic or immunologic agents directed at the malignant
             tumor

          -  One prior non-cytotoxic* (biologic or cytostatic) regimen for management of recurrent
             or persistent disease allowed

          -  See Disease Characteristics

          -  Prior paclitaxel or docetaxel allowed

          -  Recovered from prior chemotherapy

          -  No more than 1 prior cytotoxic chemotherapy regimen (either single or combination drug
             therapy)

          -  No prior ixabepilone

          -  At least 1 week since prior hormonal therapy directed at the malignant tumor

               -  Continuation of hormone replacement therapy allowed

          -  See Disease Characteristics

          -  Recovered from prior radiotherapy

          -  Recovered from prior surgery

          -  At least 3 weeks since other prior therapy directed at the malignant tumor

          -  No prior cancer treatment that contraindicates study therapy