GOG 203C: EVALUATION OF GLEEVEC IN TREATMENT OF CARCINOSARCOMA OF THE UTERUS

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Primary Objectives: 1) To determine the activity of Gleevec TM as measured by progression-free survival at six months. 2) To determine the frequency and severity of adverse effects of Gleevec TM in this cohort of patients as assessed by the Common Terminology Criteria of Adverse Events. Secondary Objectives: #) To determine the distribution of progression-free survival. 4) To estimate the objective response rate (partial and complete response rate (partial and complete response as defined under RECIST). 5) To determine effects of prognostic factors such as initial performance status and histological grade. Exploratory Objective: 6) To determine the levels of expression of c-KIT, PDGFR, AKT2, and p-AKT2 in archived, formalin-fixed, paraffin-embedded primary tumors collected prior to the initiation of first-line chemotherapy. This is a Phase II open-labeled study evaluating progression-free survival in patients treated with Gleevec TM who have recurrent or persistent carcinosarcoma of the uterus with documented disease progression after appropriate local therapy. All patients must have measurable disease in at least one dimension. Uterine sarcomas represent 2-6% of all uterine malignancies treated. In a review of British tumor registries, carcinosarcomas (CS) and leimyosarcomas (LMS) made up 90% of all uterine sarcomas registered over a 15-year period. The overall five year survival was 31% in this series. Studies have confirmed recurrence rates of 53-56%, the majority of which include an extra pelvic component. Although there was no prescribed postoperative therapy regimen in any of these studies, they highlight the lack of an efficacious adjuvant therapy. As discussed above, advanced and recurrent uterine carcinosarcomas carry a poor prognosis overall and the vast majority of studies have failed to demonstrate an improvement in overall survival with adjuvant radiation therapy or chemotherapy. As such, additional studies investigating novel agents need to be considered and implemented. This study proposes to evaluate Gleevec TM in the setting of recurrent or persistent uterine sarco