Phase I trial of carboplatin and weekly paclitaxel in patients with advanced non-small-cell lung cancer.
OBJECTIVE
This study was designed to determine the maximum tolerated dose of paclitaxel administered weekly in combination with carboplatin and to assess its dose limiting toxicity and preliminary activity in patients with previously untreated, advanced non-small-cell lung cancer.


METHODS
Carboplatin was administered at a fixed dose that maintained an area under the curve of 6. Paclitaxel was given over 1 h once a week for 3 weeks starting at 60 mg/m(2) and escalated in 10 mg/m(2) increments.


RESULTS
Twenty-one patients were treated with six dose levels (60, 70, 80, 90, 100, 110 mg/m(2)) of paclitaxel. The dose limiting toxicity was infection and the maximum tolerated dose was 110 mg/m(2). Nine of 21 (42.9%) patients demonstrated a therapeutic response.


CONCLUSIONS
Weekly paclitaxel and carboplatin were well tolerated. Based on our results, 100 mg/m(2) of paclitaxel for 3 weeks of a 4-week cycle, in combination with carboplatin, was recommended for a phase II study.
Kikuchi
Junko
J
First Department of Medicine, Hokkaido University School of Medicine, Sapporo 060-8638, Japan.
Yamazaki
Koichi
K
Kinoshita
Ichiro
I
Asahina
Hajime
H
Imura
Mikado
M
Kikuchi
Eiki
E
Konishi
Jun
J
Shinagawa
Naofumi
N
Oki
Hiromitsu
H
Dosaka-Akita
Hirotoshi
H
Nishimura
Masaharu
M
D000230:Adenocarcinoma / Q000188:drug therapy; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage
D016190:Carboplatin; D017239:Paclitaxel