A Phase I Study of Carboplatin and Docetaxel for Advanced Non-small Cell Lung Cancer Using the Continual Reassessment Method

Purpose: This phase I study was designed to determine the maximum tolerated dose of carboplatin combined with a fixed dose of docetaxel (60 mg/m2) and the safety and efficacy of this combination chemotherapy in unresectable non-small cell lung cancer. Methods: Patients received a 60 min intravenous...

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Published in:	Japanese journal of clinical oncology Vol. 32; no. 12; pp. 512 - 516
Main Authors:	Kasahara, Kazuo, Myo, Saori, Iwasa, Kei-ichi, Kimura, Hideharu, Shirasaki, Hiroki, Yasuda, Utako, Shibata, Kazuhiko, Shintani, Hiromoto, Nishi, Kohichi, Fujimura, Masaki, Nakao, Shinji
Format:	Journal Article
Language:	English
Published:	England Oxford University Press 01-12-2002 Oxford Publishing Limited (England)
Subjects:	Aged Antineoplastic Combined Chemotherapy Protocols - therapeutic use Carboplatin - administration & dosage Carboplatin - adverse effects Carcinoma, Non-Small-Cell Lung - drug therapy Docetaxel Dose-Response Relationship, Drug Drug Administration Schedule Humans Infusions, Intravenous Key words: docetaxel – carboplatin – non-small cell lung cancer – continual reassessment method Lung Neoplasms - drug therapy Maximum Tolerated Dose Middle Aged Neutropenia - chemically induced Paclitaxel - administration & dosage Paclitaxel - adverse effects Paclitaxel - analogs & derivatives Taxoids Thrombocytopenia - chemically induced
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Summary:	Purpose: This phase I study was designed to determine the maximum tolerated dose of carboplatin combined with a fixed dose of docetaxel (60 mg/m2) and the safety and efficacy of this combination chemotherapy in unresectable non-small cell lung cancer. Methods: Patients received a 60 min intravenous infusion of docetaxel followed by a 90 min infusion of carboplatin with dose escalation using the continual reassessment method. The starting dose of carboplatin was targeted to an area under the plasma concentration curve of 3 using Calvert’s equation and dose escalation was based on course 1 toxicities. Results: From January 1999 to February 2000, 16 patients entered this trial. The major dose-limiting toxicity was neutropenia. Thrombocytopenia was rare and major non-hematological toxicities included fever that was not associated with neutropenia and grade 2 nausea and vomiting. Objective responses were seen in five patients (response rate 31.3%). Conclusions: Based on this phase I clinical trial, the maximum tolerated dose of carboplatin combined with 60 mg/m2 of docetaxel was a target area under the plasma concentration curve (tAUC) of 6 and the recommended tAUC for further trials is 5.5. This combination appeared to be effective for non-small cell lung cancer. A phase II clinical trial is recommended using 60 mg/m2 of docetaxel and carboplatin with a tAUC of 5.5.
Bibliography:	ark:/67375/HXZ-V2D8CGGK-F Received May 7, 2002; accepted September 24, 2002 istex:D10DA0597922C3438C3E00AF5BC782735FF9A278 local:hyf112
ISSN:	0368-2811 1465-3621 1465-3621
DOI:	10.1093/jjco/hyf112