PHASE I STUDY OF PACLITAXEL AS RADIATION SENSITIZER IN MESOTHELIOMA

紫杉醇作为间皮瘤放射增敏剂的 I 期研究

• 批准号: 2464478
• 负责人: L HERSCHER
• 金额: --
• 依托单位: DIVISION OF CLINICAL SCIENCES - NCI
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/2464478
• 关键词: antineoplastics; biopsy; breast neoplasms; carcinoma; clinical research; clinical trial phase I; colon neoplasms; cytotoxicity; drug screening /evaluation; gastrointestinal neoplasms; human subject; human therapy evaluation; idoxuridine; mesothelioma; metastasis; neoplasm /cancer radiation therapy; neoplasm /cancer radionuclide therapy; nonsmall cell lung cancer; paclitaxel; prostate neoplasms; radiation sensitivity; radiation therapy dosage; radiosensitizer

This is a phase I study of paclitaxel as a radiation sensitizer in the treatment of unresectable mesothelioma and non-small cell lung cancer. The purpose is to determine the maximum tolerated dose of paclitaxel when delivered as a 20-hour continuous infusion every 3 weeks concurrently with thoracic irradiation to include the primary tumor site and appropriate draining lymph nodes for non-small cell lung cancer patients. Hemithorax irradiation will be employed for patients with mesothelioma. Another goal of this protocol is to understand the biology of lung cancer and mesothelioma as well as to assess the effectiveness of paclitaxel against these tumors. To achieve this goal, we will examine, among other studies, the labeling index of tumor specimens with the use of the in vivo iododeoxyuridine (IUdR) labeling technique. Studies of in vivo IUdR labeling at other centers include breast, lung, prostate, gastric, and colon carcinomas. There are very limited data from IUdR labeling of mesothelioma. We have accrued 30 patients on the protocol. The maximum tolerated dose has been determined to be 105mg/m2 infused over five days. The dose limiting toxicity at 120mg/m2 was hematologic (neutropenia) and GI (nausea and vomiting). Local control was 77% with predominant mode of failure distant metastases. One of five patients biopsied was found to have a small G2/M block characteristic of paclitaxel.

这是紫杉醇作为放射增敏剂在 治疗不可切除的间皮瘤和非小细胞肺癌。的 目的是确定紫杉醇的最大耐受剂量， 每3周持续输注20小时，同时 胸部照射，包括原发肿瘤部位和适当的 非小细胞肺癌患者的引流淋巴结。 半胸 间皮瘤患者将采用放射治疗。 另一个目标 是为了了解肺癌的生物学， 间皮瘤，以及评估紫杉醇对 这些肿瘤。 为了实现这一目标，我们将审查，除其他研究外， 肿瘤标本的标记指数与使用的体内 碘脱氧尿苷（IUdR）标记技术。 宫内节育器的体内研究 其他中心的标记包括乳腺、肺、前列腺、胃和 结肠癌 来自IUdR标记的数据非常有限， 间皮瘤 我们已经有30个病人参加了这个方案。 最大耐受剂量 已确定为在5天内输注105 mg/m2。 剂量 120 mg/m2的限制性毒性为血液学（中性粒细胞减少）和GI（恶心 呕吐）。 局部控制率为77%，主要失效模式为 远处转移 五个病人中有一个活组织检查发现有一个 紫杉醇特征性小G2/M阻滞。