FILGRASTIM SD/01 PTS W/ NON SMALL CELL LUNG CANCER OR THORACIC TUMORS

FILGRASTIM SD/01 PTS 治疗非小细胞肺癌或胸部肿瘤

• 批准号: 6264156
• 负责人: CHANDRA BELANI
• 金额: $ 0.3万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6264156
• 关键词: cis platinum compound; clinical research; clinical trial phase I; colony stimulating factor; drug interactions; drug screening /evaluation; hematopoietic stem cells; human subject; human therapy evaluation; neoplasm /cancer chemotherapy; neoplasm /cancer immunotherapy; neutrophil; nonsmall cell lung cancer; paclitaxel; pharmacokinetics; thorax neoplasm; cis platinum compound; clinical research; clinical trial phase I; colony stimulating factor; drug interactions; drug screening /evaluation; hematopoietic stem cells; human subject; human therapy evaluation; neoplasm /cancer chemotherapy; neoplasm /cancer immunotherapy; neutrophil; nonsmall cell lung cancer; paclitaxel; pharmacokinetics; thorax neoplasm

The specific aims of this study are to compare the safety of Filgrastim-SD/01 to Filgrastim administered to non-small cell lung cancer patients in hematologic steady state; and to compare the pharmacokinetics (PK) of Filgrastim-SD/01 to Filgrastim pre-chemotherapy; and to compare the pharmacodynamic (PD) responses to Filgrastim-SD/01 to Filgrastim as measured by changes in absolute neutrophil count (ANC), and hematopoietic progenitor cell levels in the peripheral blood. This is a phase I open label, dose escalation study of filgrastim SD/01 in non-small cell lung cancer patients (NSCLC) and patients with other thoracic tumors treated with carboplatin and paclitaxel (Taxol).

这项研究的具体目的是将Filgrastim-SD/01的安全性与对血液学稳态以非小细胞肺癌患者的施用的Filgrastim进行比较；并将Filgrastim-SD/01的药代动力学（PK）与Filgrastim预化学疗法进行比较；并比较通过绝对中性粒细胞计数（ANC）的变化（ANC）和外周血中的造血祖细胞水平来比较Filgrastim-SD/01对Filgrastim的反应。 这是一项I期开放标签，非小细胞肺癌患者（NSCLC）中Filgrastim SD/01的剂量升级研究，以及其他用卡泊蛋白和紫杉醇（紫杉醇）治疗的其他胸部肿瘤患者。