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: 6163424
• 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/6163424
• 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

"DISCONTINUED 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. This protocol is now closed to new accrual. It remains open for follow up only. Results were presented at ASTRO meeting and manuscript has been accepted for publication in Journal of Clinical Oncology."

“已终止 这是一项 I 期研究 紫杉醇作为放射增敏剂治疗不可切除的癌症 间皮瘤和非小细胞肺癌。目的是 确定给药时紫杉醇的最大耐受剂量 每 3 周连续输注 20 小时，同时 胸部照射包括原发肿瘤部位和 非小细胞肺癌的适当引流淋巴结 患者。患有以下疾病的患者将采用半胸照射 间皮瘤。该协议的另一个目标是了解 肺癌和间皮瘤的生物学以及评估 紫杉醇对抗这些肿瘤的有效性。为了实现这一目标 目标，我们将在其他研究中检查标签指数 使用体内碘脱氧尿苷的肿瘤标本 (IUdR) 标记技术。其他体内 IUdR 标记的研究 中心包括乳腺、肺、前列腺、胃和结肠 癌。 IUdR 标签的数据非常有限 间皮瘤。我们已经招募了 30 名接受该方案的患者。这 最大耐受剂量确定为105mg/m2 输注超过五天。 120mg/m2 的剂量限制毒性为 血液学（中性粒细胞减少症）和胃肠道（恶心和呕吐）。当地的 控制率为 77%，主要故障模式较远 转移。接受活组织检查的五名患者中的一名被发现有一个小 紫杉醇的 G2/M 阻滞特征。该协议现已关闭 到新的应计。它仍然开放，仅供后续跟进。结果是 在 ASTRO 会议上提交，手稿已被接受 发表在《临床肿瘤学杂志》上。”