Imatinib Mesylate in Treating Patients With Recurrent or Persistent Uterine Cancer
Condition: Recurrent Uterine Sarcoma; Uterine Carcinosarcoma
MeSH terms: Carcinosarcoma; Mixed Tumor, Mullerian; Recurrence
Intervention: imatinib mesylate; laboratory biomarker analysis
Intervention description: Given PO; Correlative studies
Intervention MeSH terms: Imatinib Mesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: Female
Healthy volunteers: No

Summary:

      This phase II clinical trial studies the side effects and how well imatinib mesylate works in
      treating patients with uterine cancer that has failed to respond to initial chemotherapy or
      has re-grown after therapy. Imatinib mesylate may stop the growth of tumor cells by blocking
      some of the enzymes needed for cell growth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically confirmed uterine carcinosarcoma that is persistent
             or recurrent with documented disease progression after appropriate local therapy;
             acceptable histologic type is defined as carcinosarcoma (malignant mixed Mullerian
             tumor), homologous or heterologous type

          -  All patients must have measurable disease; measurable disease is defined as at least
             one lesion that can be accurately measured in at least one dimension (longest
             dimension to be recorded); each lesion must be >= 20 mm when measured by conventional
             techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic
             resonance imaging (MRI), or >= 10 mm when measured by spiral CT

          -  Patients must have at least one "target lesion" to be used to assess response on this
             protocol as defined by RECIST; tumors within a previously irradiated field will be
             designated as "non-target" lesions

          -  Patients must not be eligible for a higher priority Gynecological Oncology Group (GOG)
             protocol, if one exists; in general, this would refer to any active GOG phase III
             protocol for the same patient population

          -  Patients who have received one prior regimen must have a GOG performance status of 0,
             1, or 2; patients who have received two prior regimens must have a GOG performance
             status of 0 or 1

          -  Recovery from effects of recent surgery, radiotherapy, or chemotherapy

               -  Patients should be free of active infection requiring antibiotics

               -  Any hormonal therapy directed at the malignant tumor must be discontinued at
                  least one week prior to registration; continuation of hormone replacement therapy
                  is permitted

               -  Any other prior therapy directed at the malignant tumor, including 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 high-dose therapy, consolidation, or
             extended therapy administered after surgical or non-surgical assessment

          -  Patients are allowed to receive, but are not required to receive, one additional
             cytotoxic regimen for management of recurrent or persistent disease according to the
             following definition:

               -  Cytotoxic regimens include any agent that targets the genetic and/or mitotic
                  apparatus of dividing cells, resulting in dose-limiting toxicity to the bone
                  marrow and/or gastrointestinal mucosa

               -  Note: Patients on this non-cytotoxic study are allowed to receive one additional
                  cytotoxic chemotherapy regimen for management of recurrent or persistent disease,
                  as defined above; however, due to the novel nature of biologic compounds,
                  patients are encouraged to enroll on second-line non-cytotoxic studies prior to
                  receiving additional cytotoxic therapy

          -  Patients must have NOT received any non-cytotoxic chemotherapy for management of
             recurrent or persistent disease

          -  Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, equivalent to
             CTCAE v3.0 grade 1

          -  Platelets greater than or equal to 100,000/mcl

          -  Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE
             v3.0 grade 1

          -  Bilirubin less than or equal to 1.5 x ULN (CTCAE v3.0 grade 1)

          -  Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 2.5 x ULN (CTCAE
             v3.0 grade 1)

          -  Alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v3.0 grade 1)

          -  Neuropathy (sensory and motor) less than or equal to CTCAE v3.0 grade 1

          -  Patients must have signed an approved informed consent and authorization permitting
             release of personal health information

          -  Patients who have met the pre-entry requirements

          -  Patients of childbearing potential must have a negative serum pregnancy test prior to
             the study entry and be practicing an effective form of contraception, and cannot be
             lactating; since interactions with the metabolism of oral contraceptives cannot be
             excluded, a barrier method of contraception must be used

          -  Patients must have tissue blocks from initial diagnosis available for submission to
             the GOG Tissue Bank

        Exclusion Criteria:

          -  Patients who had previous treatment with Gleevec^TM

          -  Patients with other invasive malignancies, with the exception of non-melanoma skin
             cancer, who had (or have) any evidence of other cancer present within the last 5 years
             or whose previous cancer treatment contraindicates this protocol therapy

          -  Patients with signs or symptoms of bowel dysfunction or obstruction

          -  Patients receiving therapeutic anticoagulation with warfarin

          -  Patients with deep venous or arterial thrombosis (including pulmonary embolism) within
             six weeks of study entry

          -  Patients receiving therapeutic corticosteroids

          -  Patients with active or uncontrolled infection

          -  History of seizures or those patients receiving phenytoin, phenobarbital, or
             carbamazepine

          -  Patients with other severe concurrent disease, which the investigator feels may make
             the patients inappropriate for study entry

          -  Presence of clinically apparent central nervous system metastases, or other
             carcinomatous meningitis

          -  History of myocardial infarction within previous six months or congestive heart
             failure requiring therapy