A phase Ib trial of docetaxel, carboplatin and erlotinib in ovarian, fallopian tube and primary peritoneal cancers
Identifieur interne : 008E92 ( Main/Merge ); précédent : 008E91; suivant : 008E93A 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.
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 1 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 1/2a/2b). The MTD of erlotinib in this regimen was determined to be 75 mg day−1 (cohort 2b; the erlotinib dose was escalated to 100 mg day−1 in 11 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.
Url:
DOI: 10.1038/sj.bjc.6604371
PubMed: 18506181
PubMed Central: 2410113
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Gabra</name><affiliation wicri:level="1"><nlm:aff id="aff5"><institution>Western General Hospital</institution> Crewe Road South, Edinburgh, Scotland EH4 2XU,<country>UK</country></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></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="1"><nlm:aff id="aff6"><institution>Centre Léon-Bérard</institution> rue Laennec, 69373, Lyon, Cedex 08,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></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"><nlm:aff id="aff7"><institution>Hopital de L'Hotel-Dieu, place du Parvis Notre-Dame</institution> 75181 Paris Cedex 4,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Paul, J" sort="Paul, J" uniqKey="Paul J" first="J" last="Paul">J. Paul</name><affiliation wicri:level="1"><nlm:aff id="aff1"><institution>CR-UK Clinical Trials Unit, Beatson Oncology Centre, Western Infirmary</institution> Dumbarton Road, Glasgow, Scotland G11 6NT,<country>UK</country></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Carty, K" sort="Carty, K" uniqKey="Carty K" first="K" last="Carty">K. Carty</name><affiliation wicri:level="1"><nlm:aff id="aff1"><institution>CR-UK Clinical Trials Unit, Beatson Oncology Centre, Western Infirmary</institution> Dumbarton Road, Glasgow, Scotland G11 6NT,<country>UK</country></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kaye, S" sort="Kaye, S" uniqKey="Kaye S" first="S" last="Kaye">S. Kaye</name><affiliation wicri:level="1"><nlm:aff id="aff8"><institution>Royal Marsden Hospital</institution> Downs Road, Sutton, Surrey SM2 5PT,<country>UK</country></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></analytic><series><title level="j">British Journal of Cancer</title><idno type="ISSN">0007-0920</idno><idno type="eISSN">1532-1827</idno><imprint><date when="2008">2008</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>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 1 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 1/2a/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 100 mg day<sup>−1</sup> in 11 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.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI></record>Pour manipuler ce document sous Unix (Dilib)
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