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

GOG 203C：格列卫治疗子宫癌肉瘤的评估

• 批准号: 7376342
• 负责人: PUI CHUN CHENG
• 金额: $ 0.1万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376342
• 关键词: GOG; 203C; EVALUATION; GLEEVEC; TREATMENT

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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。主要目标：1)通过6个月无进展生存期来确定格列卫TM的活性。2)根据不良事件通用术语标准评估格列卫TM在该队列患者中不良反应的发生频率和严重程度。次要目标：#)确定无进展生存期的分布。4)估计客观反应率(部分和完全反应率（根据RECIST定义的部分和完全反应）。5)确定预后因素如初始表现状态和组织学分级的影响。探索目的：6)测定一线化疗开始前收集的存档、福尔马林固定、石蜡包埋的原发性肿瘤中c-KIT、PDGFR、AKT2和p-AKT2的表达水平。这是一项II期开放标签研究，评估接受格列卫TM治疗的复发性或持续性子宫癌肉瘤患者在适当局部治疗后疾病进展的无进展生存期。所有患者必须至少在一个方面有可测量的疾病。子宫肉瘤占所有治疗的子宫恶性肿瘤的2-6%。在对英国肿瘤登记的回顾中，癌性肉瘤（CS）和直肌肉瘤（LMS）占15年来登记的所有子宫肉瘤的90%。在这个系列中，总5年生存率为31%。研究证实复发率为53-56%，其中大多数包括骨盆外部分。虽然在这些研究中没有规定术后治疗方案，但他们强调缺乏有效的辅助治疗。如上所述，晚期和复发性子宫癌肉瘤总体预后较差，绝大多数研究未能证明辅助放疗或化疗能改善总生存率。因此，需要考虑和实施对新型药物的进一步研究。本研究旨在评估格列卫TM在复发性或持续性子宫肉瘤中的应用价值