Clinical trial NCT00075400 (phase 2, status: completed)
Conditions: recurrent uterine sarcoma, uterine carcinosarcoma
ICD codes: G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2
Drugs: imatinib mesylate
SMILES: CN1CCN(CC2=CC=C(C=C2)C(=O)NC2=CC(NC3=NC=CC(=N3)C3=CN=CC=C3)=C(C)C=C2)CC1
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