Phase I study of mitonafide in 120 hour continuous infusion in non-small cell lung cancer

Mitonafide is the lead compound of a new series of antitumor drugs, the 3-Nitronaphthalimides, which have shown antineoplastic activity in vitro as well as in vivo. This phase I Mitonafide study in non-small cell lung cancer using a 120-hour continuous infusion (120 h. C.I.) schedule of administrati...

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Veröffentlicht in:Investigational new drugs 1992-08, Vol.10 (3), p.171-175
Hauptverfasser: ROSELL, R, CARLES, J, ABAD, A, RIBELLES, N, BARNADAS, A, BENAVIDES, A, MARTIN, M
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container_end_page 175
container_issue 3
container_start_page 171
container_title Investigational new drugs
container_volume 10
creator ROSELL, R
CARLES, J
ABAD, A
RIBELLES, N
BARNADAS, A
BENAVIDES, A
MARTIN, M
description Mitonafide is the lead compound of a new series of antitumor drugs, the 3-Nitronaphthalimides, which have shown antineoplastic activity in vitro as well as in vivo. This phase I Mitonafide study in non-small cell lung cancer using a 120-hour continuous infusion (120 h. C.I.) schedule of administration was designed to deliver the maximum amount of drug while avoiding the risk of central nervous system (CNS) toxicity, previously observed in studies with daily short (1 hour) administration schedules. Twenty patients were treated at doses ranging from 107-200 mg/m2 x 120 h. C.I. Dose-limiting toxicity with this schedule of administration was leukopenia. Other toxicities were mild or not relevant. No CNS toxicity was observed. The recommended dose for phase II C.I. Mitonafide studies is 170 mg/m2 x 120 h. C.I. in previously untreated patients. Plasma level monitoring is recommended.
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subjects Aged
Antineoplastic agents
Antineoplastic Agents - administration & dosage
Antineoplastic Agents - adverse effects
Antineoplastic Agents - blood
Biological and medical sciences
Carcinoma, Non-Small-Cell Lung - drug therapy
Chemotherapy
Female
Humans
Imides
Infusion Pumps
Isoquinolines - administration & dosage
Isoquinolines - adverse effects
Isoquinolines - blood
Leukopenia - chemically induced
Lung Neoplasms - drug therapy
Male
Medical sciences
Middle Aged
Naphthalimides
Pharmacology. Drug treatments
title Phase I study of mitonafide in 120 hour continuous infusion in non-small cell lung cancer
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