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 |
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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. |
doi_str_mv | 10.1007/BF00877242 |
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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.</description><identifier>ISSN: 0167-6997</identifier><identifier>EISSN: 1573-0646</identifier><identifier>DOI: 10.1007/BF00877242</identifier><identifier>PMID: 1330970</identifier><identifier>CODEN: INNDDK</identifier><language>eng</language><publisher>Dordrecht: Kluwer</publisher><subject>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</subject><ispartof>Investigational new drugs, 1992-08, Vol.10 (3), p.171-175</ispartof><rights>1993 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c352t-ce2b46526bae3458ce1738454768dd04b7f62066ba2c24b1db11bbd7773ccfa33</citedby><cites>FETCH-LOGICAL-c352t-ce2b46526bae3458ce1738454768dd04b7f62066ba2c24b1db11bbd7773ccfa33</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=4591190$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/1330970$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>ROSELL, R</creatorcontrib><creatorcontrib>CARLES, J</creatorcontrib><creatorcontrib>ABAD, A</creatorcontrib><creatorcontrib>RIBELLES, N</creatorcontrib><creatorcontrib>BARNADAS, A</creatorcontrib><creatorcontrib>BENAVIDES, A</creatorcontrib><creatorcontrib>MARTIN, M</creatorcontrib><title>Phase I study of mitonafide in 120 hour continuous infusion in non-small cell lung cancer</title><title>Investigational new drugs</title><addtitle>Invest New Drugs</addtitle><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.</description><subject>Aged</subject><subject>Antineoplastic agents</subject><subject>Antineoplastic Agents - administration & dosage</subject><subject>Antineoplastic Agents - adverse effects</subject><subject>Antineoplastic Agents - blood</subject><subject>Biological and medical sciences</subject><subject>Carcinoma, Non-Small-Cell Lung - drug therapy</subject><subject>Chemotherapy</subject><subject>Female</subject><subject>Humans</subject><subject>Imides</subject><subject>Infusion Pumps</subject><subject>Isoquinolines - administration & dosage</subject><subject>Isoquinolines - adverse effects</subject><subject>Isoquinolines - blood</subject><subject>Leukopenia - chemically induced</subject><subject>Lung Neoplasms - drug therapy</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Naphthalimides</subject><subject>Pharmacology. 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Drug treatments</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>ROSELL, R</creatorcontrib><creatorcontrib>CARLES, J</creatorcontrib><creatorcontrib>ABAD, A</creatorcontrib><creatorcontrib>RIBELLES, N</creatorcontrib><creatorcontrib>BARNADAS, A</creatorcontrib><creatorcontrib>BENAVIDES, A</creatorcontrib><creatorcontrib>MARTIN, M</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><jtitle>Investigational new drugs</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>ROSELL, R</au><au>CARLES, J</au><au>ABAD, A</au><au>RIBELLES, N</au><au>BARNADAS, A</au><au>BENAVIDES, A</au><au>MARTIN, M</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase I study of mitonafide in 120 hour continuous infusion in non-small cell lung cancer</atitle><jtitle>Investigational new drugs</jtitle><addtitle>Invest New Drugs</addtitle><date>1992-08-01</date><risdate>1992</risdate><volume>10</volume><issue>3</issue><spage>171</spage><epage>175</epage><pages>171-175</pages><issn>0167-6997</issn><eissn>1573-0646</eissn><coden>INNDDK</coden><abstract>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.</abstract><cop>Dordrecht</cop><pub>Kluwer</pub><pmid>1330970</pmid><doi>10.1007/BF00877242</doi><tpages>5</tpages></addata></record> |
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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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