A Phase II Evaluation of Gleevec(TM) (NCI-Supplied Agent: STI571 [Imatinib Mesylate], NSC# 716051) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus

Date de début de l'étude : 1 janvier 2004

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