Phase I/II clinical trial of weekly administration of docetaxel plus cisplatin for advanced non-small cell lung cancer

• Published in: Zhōnghuá zhŏngliú zázhì Vol. 28; no. 4; p. 309
• Main Authors: Li, Jun-ling, Zhang, Xiang-ru, Liu, Ji-wei, Chen, Zhong-yuan, Lin, Ying-cheng, Wang, Yuan-dong, Chen, Qiang, Nan, Ke-jun, Song, Shu-ping, Han, Fu-cai, Zhu, Yun-zhong, Li, Long-yun, Zheng, Yu-hong, Chu, Da-Tong
• Format: Journal Article
• Language: Chinese
• Published: China 01.04.2006
• Subjects: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Area Under Curve; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - pathology; Cisplatin - administration & dosage; Cisplatin - adverse effects; Drug Administration Schedule; Female; Humans; Lung Neoplasms - drug therapy; Lung Neoplasms - pathology; Male; Middle Aged; Neoplasm Staging; Neutropenia - chemically induced; Remission Induction; Survival Rate; Taxoids - administration & dosage; Taxoids - adverse effects; Vomiting - chemically induced
• ISSN: 0253-3766

The purpose of this phase I/II study is to investigate the safety/toxicity profile of weekly administration of docetaxel in combination with cisplatin for the chemo-naive patients with advanced non-small cell lung cancer (NSCLC), and to evaluate the efficacy of this regime. In phase I trial, 15 patients were included. IV infusion of escalating doses of docetaxel consisting of four levels from 25 to 40 mg/m2 (25, 30, 35, 40 mg/m2) on D1, 8, 15 and cisplatin of 75 mg/m2 on D1 was administered. The regime was repeated every 4 weeks. Blood samples were obtained on D1, 15 in the first cycle to measure the PK. Dose limiting toxicity (DLT) was determined in cycle 1 and defined as any grade 3 non-hematologic toxicity which could not be reverted into grade less than grade 2 within 4 days or any grade 4 hematologic toxicity. Eighty-three patients completed their phase II study with administration of docetaxel at a dose of 35 mg/m2 based on the data of phase I trial. In the phase I trial, grade 3/4 neutropenia was mainl