A phase Ib trial of docetaxel, carboplatin and erlotinib in ovarian, fallopian tube and primary peritoneal cancers
Identifieur interne : 008F13 ( Main/Exploration ); précédent : 008F12; suivant : 008F14A phase Ib trial of docetaxel, carboplatin and erlotinib in ovarian, fallopian tube and primary peritoneal cancers
Auteurs : P. A. Vasey [Royaume-Uni, Australie] ; M. Gore [Royaume-Uni] ; R. Wilson [Royaume-Uni] ; G. Rustin [Royaume-Uni] ; H. Gabra [Royaume-Uni] ; J-P. Guastalla [France] ; E. P. Lauraine [France] ; J. Paul [Royaume-Uni] ; K. Carty [Royaume-Uni] ; S. Kaye [Royaume-Uni]Source :
- British journal of cancer [ 0007-0920 ] ; 2008.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
Abstract
The safety and maximum tolerated dose (MTD) of erlotinib with docetaxel/carboplatin were assessed in patients with ovarian cancer. Chemonaive patients received intravenous docetaxel (75 mg m-2) and carboplatin (area under the curve 5) on day I of a 3-week cycle, and oral erlotinib at 50 (cohort 1), 100 (cohort 2a) or 75 mg day-1 (cohort 2b) for up to six cycles. Dose-limiting toxicities were determined in cycle 1. Forty-five patients (median age 59 years) received treatment. Dose-limiting toxicities occurred in 1/5/5 patients (cohorts I /2a/2b). The MTD of erlotinib in this regimen was determined to be 75 mg day-1 (cohort 2b; the erlotinib dose was escalated to 100mg day-1 in I I out of 19 patients from cycle 2 onwards). Neutropaenia was the predominant grade 3/4 haematological toxicity (85/100/95% respectively). Common non-haematological toxicities were diarrhoea, fatigue, nausea and rash. There were five complete and seven partial responses in 23 evaluable patients (52% response rate). Docetaxel/carboplatin had no measurable effect on erlotinib pharmacokinetics. In subsequent single-agent maintenance, erlotinib was given at 100-150 mg day-1, with manageable toxicity, until tumour progression. Further investigation of erlotinib in epithelial ovarian carcinoma may be warranted, particularly as maintenance therapy.
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Vasey</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>CR-UK Clinical Triais Unit, Beatson Oncology Centre, Western Infirmary, Dumbarton Road</s1><s2>Glasgow, Scotland GI 1 6NT</s2><s3>GBR</s3><sZ>1 aut.</sZ><sZ>8 aut.</sZ><sZ>9 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Glasgow, Scotland GI 1 6NT</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Division of Medicine, University of Queensland</s1><s2>Brisbane Q4029</s2><s3>AUS</s3><sZ>1 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Brisbane Q4029</wicri:noRegion></affiliation></author><author><name sortKey="Gore, M" sort="Gore, M" uniqKey="Gore M" first="M." last="Gore">M. 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A." last="Vasey">P. A. Vasey</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>CR-UK Clinical Triais Unit, Beatson Oncology Centre, Western Infirmary, Dumbarton Road</s1><s2>Glasgow, Scotland GI 1 6NT</s2><s3>GBR</s3><sZ>1 aut.</sZ><sZ>8 aut.</sZ><sZ>9 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Glasgow, Scotland GI 1 6NT</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Division of Medicine, University of Queensland</s1><s2>Brisbane Q4029</s2><s3>AUS</s3><sZ>1 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Brisbane Q4029</wicri:noRegion></affiliation></author><author><name sortKey="Gore, M" sort="Gore, M" uniqKey="Gore M" first="M." last="Gore">M. Gore</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Royal Marsden Hospital, Fulham Road</s1><s2>London SW15 3SW</s2><s3>GBR</s3><sZ>2 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>London SW15 3SW</wicri:noRegion></affiliation></author><author><name sortKey="Wilson, R" sort="Wilson, R" uniqKey="Wilson R" first="R." last="Wilson">R. Wilson</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Belfast City Hospital, Lisbum Road</s1><s2>Belfast, Ireland BT9 7AB</s2><s3>GBR</s3><sZ>3 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Belfast, Ireland BT9 7AB</wicri:noRegion></affiliation></author><author><name sortKey="Rustin, G" sort="Rustin, G" uniqKey="Rustin G" first="G." last="Rustin">G. Rustin</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Mount Vernon Hospital, Rickmansworth Road</s1><s2>Northwood, Hertfordshire HA6 2RN</s2><s3>GBR</s3><sZ>4 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Northwood, Hertfordshire HA6 2RN</wicri:noRegion></affiliation></author><author><name sortKey="Gabra, H" sort="Gabra, H" uniqKey="Gabra H" first="H." last="Gabra">H. Gabra</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Western General Hospital, Crewe Road South</s1><s2>Edinburgh, Scotland EH4 2XU</s2><s3>GBR</s3><sZ>5 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Edinburgh, Scotland EH4 2XU</wicri:noRegion></affiliation></author><author><name sortKey="Guastalla, J P" sort="Guastalla, J P" uniqKey="Guastalla J" first="J-P." last="Guastalla">J-P. Guastalla</name><affiliation wicri:level="3"><inist:fA14 i1="07"><s1>Centre Léon-Bérard, rue Laennec</s1><s2>69373, Lyon</s2><s3>FRA</s3><sZ>6 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Auvergne-Rhône-Alpes</region><region type="old region">Rhône-Alpes</region><settlement type="city">Lyon</settlement></placeName></affiliation></author><author><name sortKey="Lauraine, E P" sort="Lauraine, E P" uniqKey="Lauraine E" first="E. P." last="Lauraine">E. P. Lauraine</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Hopital de L'Hotel-Dieu, place du Parvis Notre-Dame</s1><s2>75181 Paris</s2><s3>FRA</s3><sZ>7 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>75181 Paris</wicri:noRegion><placeName><settlement type="city">Paris</settlement><region type="région" nuts="2">Île-de-France</region></placeName></affiliation></author><author><name sortKey="Paul, J" sort="Paul, J" uniqKey="Paul J" first="J." last="Paul">J. Paul</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>CR-UK Clinical Triais Unit, Beatson Oncology Centre, Western Infirmary, Dumbarton Road</s1><s2>Glasgow, Scotland GI 1 6NT</s2><s3>GBR</s3><sZ>1 aut.</sZ><sZ>8 aut.</sZ><sZ>9 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Glasgow, Scotland GI 1 6NT</wicri:noRegion></affiliation></author><author><name sortKey="Carty, K" sort="Carty, K" uniqKey="Carty K" first="K." last="Carty">K. Carty</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>CR-UK Clinical Triais Unit, Beatson Oncology Centre, Western Infirmary, Dumbarton Road</s1><s2>Glasgow, Scotland GI 1 6NT</s2><s3>GBR</s3><sZ>1 aut.</sZ><sZ>8 aut.</sZ><sZ>9 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Glasgow, Scotland GI 1 6NT</wicri:noRegion></affiliation></author><author><name sortKey="Kaye, S" sort="Kaye, S" uniqKey="Kaye S" first="S." last="Kaye">S. Kaye</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Royal Marsden Hospital, Downs Road</s1><s2>Sutton, Surrey SM2 5PT</s2><s3>GBR</s3><sZ>10 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Sutton, Surrey SM2 5PT</wicri:noRegion></affiliation></author></analytic><series><title level="j" type="main">British journal of cancer</title><title level="j" type="abbreviated">Br. J. cancer</title><idno type="ISSN">0007-0920</idno><imprint><date when="2008">2008</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">British journal of cancer</title><title level="j" type="abbreviated">Br. J. cancer</title><idno type="ISSN">0007-0920</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antineoplastic agent</term><term>Cancerology</term><term>Carboplatin</term><term>Clinical trial</term><term>Docetaxel</term><term>Epidermal growth factor receptor</term><term>Erlotinib</term><term>Fallopian tube cancer</term><term>Malignant tumor</term><term>Ovary</term><term>Peritoneum</term><term>Primary</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Docétaxel</term><term>Essai clinique</term><term>Ovaire</term><term>Carboplatine</term><term>Primaire</term><term>Péritoine</term><term>Erlotinib</term><term>Récepteur facteur croissance épiderme</term><term>Cancérologie</term><term>Cancer de la trompe de Fallope</term><term>Tumeur maligne</term><term>Anticancéreux</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The safety and maximum tolerated dose (MTD) of erlotinib with docetaxel/carboplatin were assessed in patients with ovarian cancer. Chemonaive patients received intravenous docetaxel (75 mg m<sup>-2</sup>) and carboplatin (area under the curve 5) on day I of a 3-week cycle, and oral erlotinib at 50 (cohort 1), 100 (cohort 2a) or 75 mg day<sup>-1</sup> (cohort 2b) for up to six cycles. Dose-limiting toxicities were determined in cycle 1. Forty-five patients (median age 59 years) received treatment. Dose-limiting toxicities occurred in 1/5/5 patients (cohorts I /2a/2b). The MTD of erlotinib in this regimen was determined to be 75 mg day<sup>-1</sup> (cohort 2b; the erlotinib dose was escalated to 100mg day<sup>-1</sup> in I I out of 19 patients from cycle 2 onwards). Neutropaenia was the predominant grade 3/4 haematological toxicity (85/100/95% respectively). Common non-haematological toxicities were diarrhoea, fatigue, nausea and rash. There were five complete and seven partial responses in 23 evaluable patients (52% response rate). Docetaxel/carboplatin had no measurable effect on erlotinib pharmacokinetics. In subsequent single-agent maintenance, erlotinib was given at 100-150 mg day<sup>-1</sup>, with manageable toxicity, until tumour progression. Further investigation of erlotinib in epithelial ovarian carcinoma may be warranted, particularly as maintenance therapy.</div></front></TEI><affiliations><list><country><li>Australie</li><li>France</li><li>Royaume-Uni</li></country><region><li>Auvergne-Rhône-Alpes</li><li>Rhône-Alpes</li><li>Île-de-France</li></region><settlement><li>Lyon</li><li>Paris</li></settlement></list><tree><country name="Royaume-Uni"><noRegion><name sortKey="Vasey, P A" sort="Vasey, P A" uniqKey="Vasey P" first="P. A." last="Vasey">P. A. Vasey</name></noRegion><name sortKey="Carty, K" sort="Carty, K" uniqKey="Carty K" first="K." last="Carty">K. Carty</name><name sortKey="Gabra, H" sort="Gabra, H" uniqKey="Gabra H" first="H." last="Gabra">H. Gabra</name><name sortKey="Gore, M" sort="Gore, M" uniqKey="Gore M" first="M." last="Gore">M. Gore</name><name sortKey="Kaye, S" sort="Kaye, S" uniqKey="Kaye S" first="S." last="Kaye">S. Kaye</name><name sortKey="Paul, J" sort="Paul, J" uniqKey="Paul J" first="J." last="Paul">J. Paul</name><name sortKey="Rustin, G" sort="Rustin, G" uniqKey="Rustin G" first="G." last="Rustin">G. Rustin</name><name sortKey="Wilson, R" sort="Wilson, R" uniqKey="Wilson R" first="R." last="Wilson">R. Wilson</name></country><country name="Australie"><noRegion><name sortKey="Vasey, P A" sort="Vasey, P A" uniqKey="Vasey P" first="P. A." last="Vasey">P. A. Vasey</name></noRegion></country><country name="France"><region name="Auvergne-Rhône-Alpes"><name sortKey="Guastalla, J P" sort="Guastalla, J P" uniqKey="Guastalla J" first="J-P." last="Guastalla">J-P. Guastalla</name></region><name sortKey="Lauraine, E P" sort="Lauraine, E P" uniqKey="Lauraine E" first="E. P." last="Lauraine">E. P. Lauraine</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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