title: Phase I/II trial of weekly paclitaxel in patients with advanced lung cancer.
abstract: During previous phase I experience of weekly paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) used as a radiation sensitizer, decreased hematologic toxicity was noted. Therefore, an extended phase I/II trial of weekly paclitaxel in patients with chemotherapy-naive, metastatic non-small cell lung cancer was conducted to determine the maximum tolerated dose and activity of this alternative schedule. Twenty-six patients entered this study through six dose levels of paclitaxel (100, 125, 135, 150, 175, and 200 mg/m2/wk) administered weekly for 6 of 8 weeks. Doses were escalated if more than 80% of the intended dose was administered in the preceding cohort without evidence of grade 3 nonhematologic toxicity. All patients had a performance status of 0 to 2 and a median age of 63 years. Sites of disease included the lung, bone, liver, soft tissue, and brain. Twenty-four patients completed the first 8-week cycle and are evaluable for toxicity and response. Dose-limiting toxicity occurred at 200 mg/m2/wk and consisted primarily of neutropenia. Only one evaluable patient required hospitalization for febrile neutropenia. Other toxicities included rash, pulmonary infiltrate, myalgia, neuropathy, and alopecia. Nine of 24 patients (38%) demonstrated objective responses. We conclude that the maximum tolerated dose of weekly paclitaxel administered for 6 weeks in an 8-week cycle is 175 mg/m2/wk. The response rate is encouraging and this schedule merits further investigation.
authors.affiliation: Rhode Island Hospital and the Clinical Oncology Group of Rhode Island, Brown University School of Medicine, Providence 02903, USA.
authors.forename: W
authors.initials: W
authors.lastname: Akerley
mesh_terms: D000505:Alopecia / Q000139:chemically induced; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000633:toxicity; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D004334:Drug Administration Schedule; D003875:Drug Eruptions / Q000209:etiology; D004361:Drug Tolerance; D006801:Humans; D008171:Lung Diseases / Q000139:chemically induced; D008175:Lung Neoplasms / Q000188:drug therapy*; D009135:Muscular Diseases / Q000139:chemically induced; D009362:Neoplasm Metastasis; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000008:administration & dosage* / Q000633:toxicity; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel