A phase Ib trial of docetaxel, carboplatin and erlotinib in ovarian, fallopian tube and primary peritoneal cancers
Identifieur interne : 002B90 ( PascalFrancis/Curation ); précédent : 002B89; suivant : 002B91A 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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<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>
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<term>Péritoine</term>
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<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>
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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>
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<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG"><s0>Ovary</s0>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA"><s0>Ovario</s0>
<s5>03</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE"><s0>Carboplatine</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>04</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG"><s0>Carboplatin</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>04</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA"><s0>Carboplatino</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>04</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE"><s0>Primaire</s0>
<s5>05</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG"><s0>Primary</s0>
<s5>05</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA"><s0>Primario</s0>
<s5>05</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE"><s0>Péritoine</s0>
<s5>06</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG"><s0>Peritoneum</s0>
<s5>06</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Peritoneo</s0>
<s5>06</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Erlotinib</s0>
<s2>FR</s2>
<s5>07</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Erlotinib</s0>
<s2>FR</s2>
<s5>07</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Erlotinib</s0>
<s2>FR</s2>
<s5>07</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE"><s0>Récepteur facteur croissance épiderme</s0>
<s5>08</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG"><s0>Epidermal growth factor receptor</s0>
<s5>08</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA"><s0>Receptor del factor de crecimiento epidérmico</s0>
<s5>08</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE"><s0>Cancérologie</s0>
<s5>09</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG"><s0>Cancerology</s0>
<s5>09</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA"><s0>Cancerología</s0>
<s5>09</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE"><s0>Cancer de la trompe de Fallope</s0>
<s2>NM</s2>
<s5>10</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG"><s0>Fallopian tube cancer</s0>
<s2>NM</s2>
<s5>10</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA"><s0>Cáncer de falopio del tubo</s0>
<s2>NM</s2>
<s5>10</s5>
</fC03>
<fC03 i1="11" i2="X" l="FRE"><s0>Tumeur maligne</s0>
<s2>NM</s2>
<s5>13</s5>
</fC03>
<fC03 i1="11" i2="X" l="ENG"><s0>Malignant tumor</s0>
<s2>NM</s2>
<s5>13</s5>
</fC03>
<fC03 i1="11" i2="X" l="SPA"><s0>Tumor maligno</s0>
<s2>NM</s2>
<s5>13</s5>
</fC03>
<fC03 i1="12" i2="X" l="FRE"><s0>Anticancéreux</s0>
<s5>25</s5>
</fC03>
<fC03 i1="12" i2="X" l="ENG"><s0>Antineoplastic agent</s0>
<s5>25</s5>
</fC03>
<fC03 i1="12" i2="X" l="SPA"><s0>Anticanceroso</s0>
<s5>25</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Cancer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Cancer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Cáncer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="02" i2="X" l="FRE"><s0>Antimitotique</s0>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG"><s0>Antimitotic</s0>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Antimitótico</s0>
<s5>37</s5>
</fC07>
<fC07 i1="03" i2="X" l="FRE"><s0>Dérivé du taxane</s0>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="ENG"><s0>Taxane derivatives</s0>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="SPA"><s0>Taxane derivado</s0>
<s5>38</s5>
</fC07>
<fC07 i1="04" i2="X" l="FRE"><s0>Platine II Complexe</s0>
<s2>NC</s2>
<s2>NA</s2>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="ENG"><s0>Platinum II Complexes</s0>
<s2>NC</s2>
<s2>NA</s2>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="SPA"><s0>Platino II Complejo</s0>
<s2>NC</s2>
<s2>NA</s2>
<s5>39</s5>
</fC07>
<fC07 i1="05" i2="X" l="FRE"><s0>Inhibiteur enzyme</s0>
<s5>40</s5>
</fC07>
<fC07 i1="05" i2="X" l="ENG"><s0>Enzyme inhibitor</s0>
<s5>40</s5>
</fC07>
<fC07 i1="05" i2="X" l="SPA"><s0>Inhibidor enzima</s0>
<s5>40</s5>
</fC07>
<fC07 i1="06" i2="X" l="FRE"><s0>Dérivé de la quinazoline</s0>
<s2>FR</s2>
<s5>41</s5>
</fC07>
<fC07 i1="06" i2="X" l="ENG"><s0>Quinazoline derivatives</s0>
<s2>FR</s2>
<s5>41</s5>
</fC07>
<fC07 i1="07" i2="X" l="FRE"><s0>Protein-tyrosine kinase</s0>
<s2>FE</s2>
<s5>42</s5>
</fC07>
<fC07 i1="07" i2="X" l="ENG"><s0>Protein-tyrosine kinase</s0>
<s2>FE</s2>
<s5>42</s5>
</fC07>
<fC07 i1="07" i2="X" l="SPA"><s0>Protein-tyrosine kinase</s0>
<s2>FE</s2>
<s5>42</s5>
</fC07>
<fC07 i1="08" i2="X" l="FRE"><s0>Transferases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="08" i2="X" l="ENG"><s0>Transferases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="08" i2="X" l="SPA"><s0>Transferases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="09" i2="X" l="FRE"><s0>Enzyme</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="09" i2="X" l="ENG"><s0>Enzyme</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="09" i2="X" l="SPA"><s0>Enzima</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="10" i2="X" l="FRE"><s0>Inhibiteur de la tyrosine kinase</s0>
<s5>43</s5>
</fC07>
<fC07 i1="10" i2="X" l="ENG"><s0>Tyrosine kinase inhibitor</s0>
<s5>43</s5>
</fC07>
<fC07 i1="10" i2="X" l="SPA"><s0>Inhibidor tyrosine kinase</s0>
<s5>43</s5>
</fC07>
<fC07 i1="11" i2="X" l="FRE"><s0>Appareil génital femelle</s0>
<s5>45</s5>
</fC07>
<fC07 i1="11" i2="X" l="ENG"><s0>Female genital system</s0>
<s5>45</s5>
</fC07>
<fC07 i1="11" i2="X" l="SPA"><s0>Aparato genital hembra</s0>
<s5>45</s5>
</fC07>
<fC07 i1="12" i2="X" l="FRE"><s0>Pathologie de l'appareil génital femelle</s0>
<s5>46</s5>
</fC07>
<fC07 i1="12" i2="X" l="ENG"><s0>Female genital diseases</s0>
<s5>46</s5>
</fC07>
<fC07 i1="12" i2="X" l="SPA"><s0>Aparato genital hembra patología</s0>
<s5>46</s5>
</fC07>
<fC07 i1="13" i2="X" l="FRE"><s0>Pathologie de la trompe de Fallope</s0>
<s5>47</s5>
</fC07>
<fC07 i1="13" i2="X" l="ENG"><s0>Fallopian tube pathology</s0>
<s5>47</s5>
</fC07>
<fC07 i1="13" i2="X" l="SPA"><s0>Trompa Falopio patología</s0>
<s5>47</s5>
</fC07>
<fN21><s1>196</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
</fN82>
</pA>
</standard>
</inist>
</record>
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