phase I/II trial of docetaxel and oxaliplatin in patients with advanced gastric cancer

Purpose We designed this phase I/II study of docetaxel-oxaliplatin combination chemotherapy to determine the dose-limiting toxicity (DLT), maximum tolerated dose and efficacy as a first-line treatment in patients with advanced gastric cancer. Methods Patients with histologically proven, chemo-naive...

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Veröffentlicht in:Cancer chemotherapy and pharmacology 2009-07, Vol.64 (2), p.347-353
Hauptverfasser: Kim, Kyoung Ha, Park, Young Suk, Chang, Myung Hee, Kim, Hyo Song, Jun, Hyun Jung, Uhm, Jieun, Yi, Seong Yoon, Lim, Do Hyoung, Ji, Sang Hoon, Park, Min Jae, Lee, Jeeyun, Park, Se Hoon, Park, Joon Oh, Lim, Ho Yeong, Kang, Won Ki
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container_end_page 353
container_issue 2
container_start_page 347
container_title Cancer chemotherapy and pharmacology
container_volume 64
creator Kim, Kyoung Ha
Park, Young Suk
Chang, Myung Hee
Kim, Hyo Song
Jun, Hyun Jung
Uhm, Jieun
Yi, Seong Yoon
Lim, Do Hyoung
Ji, Sang Hoon
Park, Min Jae
Lee, Jeeyun
Park, Se Hoon
Park, Joon Oh
Lim, Ho Yeong
Kang, Won Ki
description Purpose We designed this phase I/II study of docetaxel-oxaliplatin combination chemotherapy to determine the dose-limiting toxicity (DLT), maximum tolerated dose and efficacy as a first-line treatment in patients with advanced gastric cancer. Methods Patients with histologically proven, chemo-naive gastric adenocarcinoma were eligible. For the phase I part, three dose levels of oxaliplatin and docetaxel every 3 weeks were tested in a cohort of three patients for each level (respectively, 100 and 60 mg/m², 100 and 75 mg/m², 130 and 75 mg/m²). Patients were treated up to a maximum of nine cycles of oxaliplatin and docetaxel unless there was documented disease progression, an unacceptable adverse event, or withdrawal of consent. Results No DLT was observed at any of the three levels tested in the phase I portion. Therefore, oxaliplatin 130 mg/m² and docetaxel 75 mg/m² were recommended for the phase II study. All 47 patients were evaluable for toxicity and treatment response. The overall response rate was 55.3% (95% CI, 40.6-70.1%) and median duration of response was 4.2 months (range 0.9-9.5 months). After a median follow-up duration of 13.3 months, median overall survival was 12.7 months (95% CI: 10.4-14.9). The median time to progression was 5.0 months (95% CI, 3.4-6.5 months). The main toxicities (grade 3 or 4) were febrile neutropenia (14.9%), neutropenia (23.4%), diarrhea (10.6%) and neurotoxicity (8.5%). Conclusion The combination of docetaxel and oxaliplatin was feasible with favorable toxicity profile and showed a promising anti-tumor activity in unresectable, metastatic gastric cancer patients.
doi_str_mv 10.1007/s00280-008-0878-4
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Methods Patients with histologically proven, chemo-naive gastric adenocarcinoma were eligible. For the phase I part, three dose levels of oxaliplatin and docetaxel every 3 weeks were tested in a cohort of three patients for each level (respectively, 100 and 60 mg/m², 100 and 75 mg/m², 130 and 75 mg/m²). Patients were treated up to a maximum of nine cycles of oxaliplatin and docetaxel unless there was documented disease progression, an unacceptable adverse event, or withdrawal of consent. Results No DLT was observed at any of the three levels tested in the phase I portion. Therefore, oxaliplatin 130 mg/m² and docetaxel 75 mg/m² were recommended for the phase II study. All 47 patients were evaluable for toxicity and treatment response. The overall response rate was 55.3% (95% CI, 40.6-70.1%) and median duration of response was 4.2 months (range 0.9-9.5 months). After a median follow-up duration of 13.3 months, median overall survival was 12.7 months (95% CI: 10.4-14.9). The median time to progression was 5.0 months (95% CI, 3.4-6.5 months). The main toxicities (grade 3 or 4) were febrile neutropenia (14.9%), neutropenia (23.4%), diarrhea (10.6%) and neurotoxicity (8.5%). Conclusion The combination of docetaxel and oxaliplatin was feasible with favorable toxicity profile and showed a promising anti-tumor activity in unresectable, metastatic gastric cancer patients.</description><identifier>ISSN: 0344-5704</identifier><identifier>EISSN: 1432-0843</identifier><identifier>DOI: 10.1007/s00280-008-0878-4</identifier><identifier>PMID: 19066894</identifier><identifier>CODEN: CCPHDZ</identifier><language>eng</language><publisher>Berlin/Heidelberg: Berlin/Heidelberg : Springer-Verlag</publisher><subject>Adenocarcinoma - drug therapy ; Adenocarcinoma - secondary ; Adult ; Aged ; Antineoplastic agents ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biological and medical sciences ; Cancer Research ; Feasibility Studies ; Female ; Gastroenterology. Liver. Pancreas. Abdomen ; Humans ; Lymphatic Metastasis ; Male ; Maximum Tolerated Dose ; Medical sciences ; Medicine ; Medicine &amp; Public Health ; Middle Aged ; Neoplasm Staging ; Oncology ; Organoplatinum Compounds - administration &amp; dosage ; Original Article ; Pharmacology. Drug treatments ; Pharmacology/Toxicology ; Prognosis ; Stomach Neoplasms - drug therapy ; Stomach Neoplasms - pathology ; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus ; Survival Rate ; Taxoids - administration &amp; dosage ; Treatment Outcome ; Tumors</subject><ispartof>Cancer chemotherapy and pharmacology, 2009-07, Vol.64 (2), p.347-353</ispartof><rights>Springer-Verlag 2008</rights><rights>2009 INIST-CNRS</rights><rights>Springer-Verlag 2009</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c454t-8eab4dc829c19a1573e4138fa32273c8fdb6ad9356c871c7247a7cee6335a5b33</citedby><cites>FETCH-LOGICAL-c454t-8eab4dc829c19a1573e4138fa32273c8fdb6ad9356c871c7247a7cee6335a5b33</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00280-008-0878-4$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00280-008-0878-4$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&amp;idt=21550127$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19066894$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kim, Kyoung Ha</creatorcontrib><creatorcontrib>Park, Young Suk</creatorcontrib><creatorcontrib>Chang, Myung Hee</creatorcontrib><creatorcontrib>Kim, Hyo Song</creatorcontrib><creatorcontrib>Jun, Hyun Jung</creatorcontrib><creatorcontrib>Uhm, Jieun</creatorcontrib><creatorcontrib>Yi, Seong Yoon</creatorcontrib><creatorcontrib>Lim, Do Hyoung</creatorcontrib><creatorcontrib>Ji, Sang Hoon</creatorcontrib><creatorcontrib>Park, Min Jae</creatorcontrib><creatorcontrib>Lee, Jeeyun</creatorcontrib><creatorcontrib>Park, Se Hoon</creatorcontrib><creatorcontrib>Park, Joon Oh</creatorcontrib><creatorcontrib>Lim, Ho Yeong</creatorcontrib><creatorcontrib>Kang, Won Ki</creatorcontrib><title>phase I/II trial of docetaxel and oxaliplatin in patients with advanced gastric cancer</title><title>Cancer chemotherapy and pharmacology</title><addtitle>Cancer Chemother Pharmacol</addtitle><addtitle>Cancer Chemother Pharmacol</addtitle><description>Purpose We designed this phase I/II study of docetaxel-oxaliplatin combination chemotherapy to determine the dose-limiting toxicity (DLT), maximum tolerated dose and efficacy as a first-line treatment in patients with advanced gastric cancer. Methods Patients with histologically proven, chemo-naive gastric adenocarcinoma were eligible. For the phase I part, three dose levels of oxaliplatin and docetaxel every 3 weeks were tested in a cohort of three patients for each level (respectively, 100 and 60 mg/m², 100 and 75 mg/m², 130 and 75 mg/m²). Patients were treated up to a maximum of nine cycles of oxaliplatin and docetaxel unless there was documented disease progression, an unacceptable adverse event, or withdrawal of consent. Results No DLT was observed at any of the three levels tested in the phase I portion. Therefore, oxaliplatin 130 mg/m² and docetaxel 75 mg/m² were recommended for the phase II study. All 47 patients were evaluable for toxicity and treatment response. The overall response rate was 55.3% (95% CI, 40.6-70.1%) and median duration of response was 4.2 months (range 0.9-9.5 months). After a median follow-up duration of 13.3 months, median overall survival was 12.7 months (95% CI: 10.4-14.9). The median time to progression was 5.0 months (95% CI, 3.4-6.5 months). The main toxicities (grade 3 or 4) were febrile neutropenia (14.9%), neutropenia (23.4%), diarrhea (10.6%) and neurotoxicity (8.5%). Conclusion The combination of docetaxel and oxaliplatin was feasible with favorable toxicity profile and showed a promising anti-tumor activity in unresectable, metastatic gastric cancer patients.</description><subject>Adenocarcinoma - drug therapy</subject><subject>Adenocarcinoma - secondary</subject><subject>Adult</subject><subject>Aged</subject><subject>Antineoplastic agents</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Cancer Research</subject><subject>Feasibility Studies</subject><subject>Female</subject><subject>Gastroenterology. Liver. Pancreas. Abdomen</subject><subject>Humans</subject><subject>Lymphatic Metastasis</subject><subject>Male</subject><subject>Maximum Tolerated Dose</subject><subject>Medical sciences</subject><subject>Medicine</subject><subject>Medicine &amp; Public Health</subject><subject>Middle Aged</subject><subject>Neoplasm Staging</subject><subject>Oncology</subject><subject>Organoplatinum Compounds - administration &amp; dosage</subject><subject>Original Article</subject><subject>Pharmacology. Drug treatments</subject><subject>Pharmacology/Toxicology</subject><subject>Prognosis</subject><subject>Stomach Neoplasms - drug therapy</subject><subject>Stomach Neoplasms - pathology</subject><subject>Stomach. Duodenum. Small intestine. Colon. Rectum. Anus</subject><subject>Survival Rate</subject><subject>Taxoids - administration &amp; dosage</subject><subject>Treatment Outcome</subject><subject>Tumors</subject><issn>0344-5704</issn><issn>1432-0843</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp9kEFr3DAQhUVJaTbb_oBeElFIbm5GGsmSjyE0yUKghza9illZ3jh4bUfytum_rxYvDfRQEEiDvvf09Bj7KOCzADCXCUBaKABsAdbYQr1hC6FQ5knhEVsAKlVoA-qYnaT0BABKIL5jx6KCsrSVWrAf4yOlwFeXqxWfYksdHxpeDz5M9BI6Tn3Nhxfq2rGjqe15XmM-hH5K_Fc7PXKqf1LvQ803lLLec78f43v2tqEuhQ-Hfckebr58v74r7r_erq6v7guvtJoKG2itam9l5UVFQhsMOaFtCKU06G1Tr0uqK9Slt0Z4I5Uh40MoETXpNeKSXcy-YxyedyFNbtsmH7qO-jDskpNCqlJLmcFP_4BPwy72OVtmUIOqrM2QmCEfh5RiaNwY2y3F306A2zfu5sZdbtztG3cqa04Pxrv1NtSvikPFGTg_AJQ8dU3MBbXpLyeF1iDyb5dMzlzKV_0mxNeE_3v9bBY1NDjaxGz88E2CQBAlVqqs8A-vPKBp</recordid><startdate>20090701</startdate><enddate>20090701</enddate><creator>Kim, Kyoung Ha</creator><creator>Park, Young Suk</creator><creator>Chang, Myung Hee</creator><creator>Kim, Hyo Song</creator><creator>Jun, Hyun Jung</creator><creator>Uhm, Jieun</creator><creator>Yi, Seong Yoon</creator><creator>Lim, Do Hyoung</creator><creator>Ji, Sang Hoon</creator><creator>Park, Min Jae</creator><creator>Lee, Jeeyun</creator><creator>Park, Se Hoon</creator><creator>Park, Joon Oh</creator><creator>Lim, Ho Yeong</creator><creator>Kang, Won Ki</creator><general>Berlin/Heidelberg : Springer-Verlag</general><general>Springer-Verlag</general><general>Springer</general><general>Springer Nature B.V</general><scope>FBQ</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7TO</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7U7</scope><scope>C1K</scope></search><sort><creationdate>20090701</creationdate><title>phase I/II trial of docetaxel and oxaliplatin in patients with advanced gastric cancer</title><author>Kim, Kyoung Ha ; Park, Young Suk ; Chang, Myung Hee ; Kim, Hyo Song ; Jun, Hyun Jung ; Uhm, Jieun ; Yi, Seong Yoon ; Lim, Do Hyoung ; Ji, Sang Hoon ; Park, Min Jae ; Lee, Jeeyun ; Park, Se Hoon ; Park, Joon Oh ; Lim, Ho Yeong ; Kang, Won Ki</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c454t-8eab4dc829c19a1573e4138fa32273c8fdb6ad9356c871c7247a7cee6335a5b33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Adenocarcinoma - drug therapy</topic><topic>Adenocarcinoma - secondary</topic><topic>Adult</topic><topic>Aged</topic><topic>Antineoplastic agents</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Cancer Research</topic><topic>Feasibility Studies</topic><topic>Female</topic><topic>Gastroenterology. Liver. Pancreas. Abdomen</topic><topic>Humans</topic><topic>Lymphatic Metastasis</topic><topic>Male</topic><topic>Maximum Tolerated Dose</topic><topic>Medical sciences</topic><topic>Medicine</topic><topic>Medicine &amp; Public Health</topic><topic>Middle Aged</topic><topic>Neoplasm Staging</topic><topic>Oncology</topic><topic>Organoplatinum Compounds - administration &amp; dosage</topic><topic>Original Article</topic><topic>Pharmacology. Drug treatments</topic><topic>Pharmacology/Toxicology</topic><topic>Prognosis</topic><topic>Stomach Neoplasms - drug therapy</topic><topic>Stomach Neoplasms - pathology</topic><topic>Stomach. Duodenum. Small intestine. Colon. Rectum. Anus</topic><topic>Survival Rate</topic><topic>Taxoids - administration &amp; dosage</topic><topic>Treatment Outcome</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kim, Kyoung Ha</creatorcontrib><creatorcontrib>Park, Young Suk</creatorcontrib><creatorcontrib>Chang, Myung Hee</creatorcontrib><creatorcontrib>Kim, Hyo Song</creatorcontrib><creatorcontrib>Jun, Hyun Jung</creatorcontrib><creatorcontrib>Uhm, Jieun</creatorcontrib><creatorcontrib>Yi, Seong Yoon</creatorcontrib><creatorcontrib>Lim, Do Hyoung</creatorcontrib><creatorcontrib>Ji, Sang Hoon</creatorcontrib><creatorcontrib>Park, Min Jae</creatorcontrib><creatorcontrib>Lee, Jeeyun</creatorcontrib><creatorcontrib>Park, Se Hoon</creatorcontrib><creatorcontrib>Park, Joon Oh</creatorcontrib><creatorcontrib>Lim, Ho Yeong</creatorcontrib><creatorcontrib>Kang, Won Ki</creatorcontrib><collection>AGRIS</collection><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><collection>ProQuest Central (Corporate)</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Health &amp; Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>Health &amp; Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><jtitle>Cancer chemotherapy and pharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kim, Kyoung Ha</au><au>Park, Young Suk</au><au>Chang, Myung Hee</au><au>Kim, Hyo Song</au><au>Jun, Hyun Jung</au><au>Uhm, Jieun</au><au>Yi, Seong Yoon</au><au>Lim, Do Hyoung</au><au>Ji, Sang Hoon</au><au>Park, Min Jae</au><au>Lee, Jeeyun</au><au>Park, Se Hoon</au><au>Park, Joon Oh</au><au>Lim, Ho Yeong</au><au>Kang, Won Ki</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>phase I/II trial of docetaxel and oxaliplatin in patients with advanced gastric cancer</atitle><jtitle>Cancer chemotherapy and pharmacology</jtitle><stitle>Cancer Chemother Pharmacol</stitle><addtitle>Cancer Chemother Pharmacol</addtitle><date>2009-07-01</date><risdate>2009</risdate><volume>64</volume><issue>2</issue><spage>347</spage><epage>353</epage><pages>347-353</pages><issn>0344-5704</issn><eissn>1432-0843</eissn><coden>CCPHDZ</coden><abstract>Purpose We designed this phase I/II study of docetaxel-oxaliplatin combination chemotherapy to determine the dose-limiting toxicity (DLT), maximum tolerated dose and efficacy as a first-line treatment in patients with advanced gastric cancer. Methods Patients with histologically proven, chemo-naive gastric adenocarcinoma were eligible. For the phase I part, three dose levels of oxaliplatin and docetaxel every 3 weeks were tested in a cohort of three patients for each level (respectively, 100 and 60 mg/m², 100 and 75 mg/m², 130 and 75 mg/m²). Patients were treated up to a maximum of nine cycles of oxaliplatin and docetaxel unless there was documented disease progression, an unacceptable adverse event, or withdrawal of consent. Results No DLT was observed at any of the three levels tested in the phase I portion. Therefore, oxaliplatin 130 mg/m² and docetaxel 75 mg/m² were recommended for the phase II study. All 47 patients were evaluable for toxicity and treatment response. The overall response rate was 55.3% (95% CI, 40.6-70.1%) and median duration of response was 4.2 months (range 0.9-9.5 months). After a median follow-up duration of 13.3 months, median overall survival was 12.7 months (95% CI: 10.4-14.9). The median time to progression was 5.0 months (95% CI, 3.4-6.5 months). The main toxicities (grade 3 or 4) were febrile neutropenia (14.9%), neutropenia (23.4%), diarrhea (10.6%) and neurotoxicity (8.5%). Conclusion The combination of docetaxel and oxaliplatin was feasible with favorable toxicity profile and showed a promising anti-tumor activity in unresectable, metastatic gastric cancer patients.</abstract><cop>Berlin/Heidelberg</cop><pub>Berlin/Heidelberg : Springer-Verlag</pub><pmid>19066894</pmid><doi>10.1007/s00280-008-0878-4</doi><tpages>7</tpages></addata></record>
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subjects Adenocarcinoma - drug therapy
Adenocarcinoma - secondary
Adult
Aged
Antineoplastic agents
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Biological and medical sciences
Cancer Research
Feasibility Studies
Female
Gastroenterology. Liver. Pancreas. Abdomen
Humans
Lymphatic Metastasis
Male
Maximum Tolerated Dose
Medical sciences
Medicine
Medicine & Public Health
Middle Aged
Neoplasm Staging
Oncology
Organoplatinum Compounds - administration & dosage
Original Article
Pharmacology. Drug treatments
Pharmacology/Toxicology
Prognosis
Stomach Neoplasms - drug therapy
Stomach Neoplasms - pathology
Stomach. Duodenum. Small intestine. Colon. Rectum. Anus
Survival Rate
Taxoids - administration & dosage
Treatment Outcome
Tumors
title phase I/II trial of docetaxel and oxaliplatin in patients with advanced gastric cancer
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