A Phase I/II Study of Carboplatin and Paclitaxel in Patients with Epithelial Ovarian Cancer
Background: This study was conducted to investigate the recommended dose of paclitaxel for use in combination with a fixed dose of carboplatin and to evaluate the toxicity and efficacy of carboplatin–paclitaxel combination chemotherapy in patients with epithelial ovarian cancer. Methods: One hundred...
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| Veröffentlicht in: | Japanese journal of clinical oncology 2002-04, Vol.32 (4), p.128-134 |
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| creator | Yamamoto, Ritsu Minobe, Shinichiro Kaneuchi, Masanori Sakuragi, Noriaki Fujimoto, Seiichiro Ishizaki, Yoshiaki Domon, Hiroka Hareyama, Hitoshi Sato, Chikara Fujino, Takahumi Kawaguchi, Isao Yamaguchi, Tatsumi Fujimoto, Toshio Yoshiaki, Ken |
| description | Background: This study was conducted to investigate the recommended dose of paclitaxel for use in combination with a fixed dose of carboplatin and to evaluate the toxicity and efficacy of carboplatin–paclitaxel combination chemotherapy in patients with epithelial ovarian cancer. Methods: One hundred and ten patients were enrolled in the Phase I/II study and 97 patients were evaluated for further analysis, excluding 13 ineligible patients or patients with infringement of protocol: 15 patients for the Phase I and 82 for the Phase II study. In the Phase I trial, we studied dose escalation using a carboplatin dose of AUC 5 and paclitaxel levels of 150, 175 and 200 mg/m2. The grades of toxicity of the regimen of all patients enrolled in the Phase II study (n = 82), the progression-free survival time (PFS) of optimal-debulked patients and complete responders (n = 62) and the response rate of suboptimal-debulked patients (n = 39) were investigated. Results: After observing grade 4 neutropenia in four of six patients in the paclitaxel 200 mg/m2 administration group, we chose 175 mg/m2 as the recommended dose of paclitaxel in this regimen. At this dose, the median of PFS and response rate were 432 days (range, 19–907 days) and 66.7%, respectively. Conclusion: Combination chemotherapy using paclitaxel 175 mg/m2 and carboplatin AUC 5 is very well tolerated and highly effective for the treatment of ovarian cancer. |
| doi_str_mv | 10.1093/jjco/hyf029 |
| format | Article |
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Methods: One hundred and ten patients were enrolled in the Phase I/II study and 97 patients were evaluated for further analysis, excluding 13 ineligible patients or patients with infringement of protocol: 15 patients for the Phase I and 82 for the Phase II study. In the Phase I trial, we studied dose escalation using a carboplatin dose of AUC 5 and paclitaxel levels of 150, 175 and 200 mg/m2. The grades of toxicity of the regimen of all patients enrolled in the Phase II study (n = 82), the progression-free survival time (PFS) of optimal-debulked patients and complete responders (n = 62) and the response rate of suboptimal-debulked patients (n = 39) were investigated. Results: After observing grade 4 neutropenia in four of six patients in the paclitaxel 200 mg/m2 administration group, we chose 175 mg/m2 as the recommended dose of paclitaxel in this regimen. At this dose, the median of PFS and response rate were 432 days (range, 19–907 days) and 66.7%, respectively. Conclusion: Combination chemotherapy using paclitaxel 175 mg/m2 and carboplatin AUC 5 is very well tolerated and highly effective for the treatment of ovarian cancer.</description><identifier>ISSN: 0368-2811</identifier><identifier>ISSN: 1465-3621</identifier><identifier>EISSN: 1465-3621</identifier><identifier>DOI: 10.1093/jjco/hyf029</identifier><identifier>PMID: 12072422</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Carboplatin - administration & dosage ; Carcinoma - drug therapy ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Female ; Hematologic Diseases - chemically induced ; Humans ; Key words: carboplatin – ovarian cancer – paclitaxel ; Middle Aged ; Ovarian cancer ; Ovarian Neoplasms - drug therapy ; Paclitaxel - administration & dosage</subject><ispartof>Japanese journal of clinical oncology, 2002-04, Vol.32 (4), p.128-134</ispartof><rights>Copyright Oxford University Press(England) Apr 1, 2002</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c413t-5dc97898930961d603d33d5666655477c74c4c595336102639950ac280ccbe003</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27903,27904</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/12072422$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Yamamoto, Ritsu</creatorcontrib><creatorcontrib>Minobe, Shinichiro</creatorcontrib><creatorcontrib>Kaneuchi, Masanori</creatorcontrib><creatorcontrib>Sakuragi, Noriaki</creatorcontrib><creatorcontrib>Fujimoto, Seiichiro</creatorcontrib><creatorcontrib>Ishizaki, Yoshiaki</creatorcontrib><creatorcontrib>Domon, Hiroka</creatorcontrib><creatorcontrib>Hareyama, Hitoshi</creatorcontrib><creatorcontrib>Sato, Chikara</creatorcontrib><creatorcontrib>Fujino, Takahumi</creatorcontrib><creatorcontrib>Kawaguchi, Isao</creatorcontrib><creatorcontrib>Yamaguchi, Tatsumi</creatorcontrib><creatorcontrib>Fujimoto, Toshio</creatorcontrib><creatorcontrib>Yoshiaki, Ken</creatorcontrib><title>A Phase I/II Study of Carboplatin and Paclitaxel in Patients with Epithelial Ovarian Cancer</title><title>Japanese journal of clinical oncology</title><addtitle>JJCO</addtitle><description>Background: This study was conducted to investigate the recommended dose of paclitaxel for use in combination with a fixed dose of carboplatin and to evaluate the toxicity and efficacy of carboplatin–paclitaxel combination chemotherapy in patients with epithelial ovarian cancer. Methods: One hundred and ten patients were enrolled in the Phase I/II study and 97 patients were evaluated for further analysis, excluding 13 ineligible patients or patients with infringement of protocol: 15 patients for the Phase I and 82 for the Phase II study. In the Phase I trial, we studied dose escalation using a carboplatin dose of AUC 5 and paclitaxel levels of 150, 175 and 200 mg/m2. The grades of toxicity of the regimen of all patients enrolled in the Phase II study (n = 82), the progression-free survival time (PFS) of optimal-debulked patients and complete responders (n = 62) and the response rate of suboptimal-debulked patients (n = 39) were investigated. Results: After observing grade 4 neutropenia in four of six patients in the paclitaxel 200 mg/m2 administration group, we chose 175 mg/m2 as the recommended dose of paclitaxel in this regimen. At this dose, the median of PFS and response rate were 432 days (range, 19–907 days) and 66.7%, respectively. Conclusion: Combination chemotherapy using paclitaxel 175 mg/m2 and carboplatin AUC 5 is very well tolerated and highly effective for the treatment of ovarian cancer.</description><subject>Adult</subject><subject>Aged</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Carboplatin - administration & dosage</subject><subject>Carcinoma - drug therapy</subject><subject>Dose-Response Relationship, Drug</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Hematologic Diseases - chemically induced</subject><subject>Humans</subject><subject>Key words: carboplatin – ovarian cancer – paclitaxel</subject><subject>Middle Aged</subject><subject>Ovarian cancer</subject><subject>Ovarian Neoplasms - drug therapy</subject><subject>Paclitaxel - administration & dosage</subject><issn>0368-2811</issn><issn>1465-3621</issn><issn>1465-3621</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2002</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkM1LAzEQxYMotlZP3iV4lbX52CSbY6n9WChYqErRQ0izKd263a3JVtv_3pQtOocZePObN_AAuMXoESNJu-u1qbqrwxIReQbaOOYsopzgc9BGlCcRSTBugSvv1wghlsTiErQwQYLEhLTBRw9OV9pbmHbTFM7qXXaA1RL2tVtU20LXeQl1mcGpNkVe670tYFCmQbdl7eFPXq_gYBu6LXJdwOdv7XJdhvPSWHcNLpa68PbmNDvgdTh46Y-jyfMo7fcmkYkxrSOWGSkSmUiKJMcZRzSjNGM8FGOxEEbEJjZMMko5RoRTKRnShiTImIVFiHbAfeO7ddXXzvparaudK8NLRbDAGCdCBuihgYyrvHd2qbYu32h3UBipY47qmKNqcgz03clyt9jY7J89BReAqAFyX9v93167T8UFFUyN5-_qaYTfhmw2VHP6C37Ce4o</recordid><startdate>20020401</startdate><enddate>20020401</enddate><creator>Yamamoto, Ritsu</creator><creator>Minobe, Shinichiro</creator><creator>Kaneuchi, Masanori</creator><creator>Sakuragi, Noriaki</creator><creator>Fujimoto, Seiichiro</creator><creator>Ishizaki, Yoshiaki</creator><creator>Domon, Hiroka</creator><creator>Hareyama, Hitoshi</creator><creator>Sato, Chikara</creator><creator>Fujino, Takahumi</creator><creator>Kawaguchi, Isao</creator><creator>Yamaguchi, Tatsumi</creator><creator>Fujimoto, Toshio</creator><creator>Yoshiaki, Ken</creator><general>Oxford University Press</general><general>Oxford Publishing Limited (England)</general><scope>BSCLL</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>7T5</scope><scope>7T7</scope><scope>7TM</scope><scope>7TO</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>P64</scope></search><sort><creationdate>20020401</creationdate><title>A Phase I/II Study of Carboplatin and Paclitaxel in Patients with Epithelial Ovarian Cancer</title><author>Yamamoto, Ritsu ; Minobe, Shinichiro ; Kaneuchi, Masanori ; Sakuragi, Noriaki ; Fujimoto, Seiichiro ; Ishizaki, Yoshiaki ; Domon, Hiroka ; Hareyama, Hitoshi ; Sato, Chikara ; Fujino, Takahumi ; Kawaguchi, Isao ; Yamaguchi, Tatsumi ; Fujimoto, Toshio ; Yoshiaki, Ken</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c413t-5dc97898930961d603d33d5666655477c74c4c595336102639950ac280ccbe003</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2002</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Carboplatin - administration & dosage</topic><topic>Carcinoma - drug therapy</topic><topic>Dose-Response Relationship, Drug</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>Hematologic Diseases - chemically induced</topic><topic>Humans</topic><topic>Key words: carboplatin – ovarian cancer – paclitaxel</topic><topic>Middle Aged</topic><topic>Ovarian cancer</topic><topic>Ovarian Neoplasms - drug therapy</topic><topic>Paclitaxel - administration & dosage</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Yamamoto, Ritsu</creatorcontrib><creatorcontrib>Minobe, Shinichiro</creatorcontrib><creatorcontrib>Kaneuchi, Masanori</creatorcontrib><creatorcontrib>Sakuragi, Noriaki</creatorcontrib><creatorcontrib>Fujimoto, Seiichiro</creatorcontrib><creatorcontrib>Ishizaki, Yoshiaki</creatorcontrib><creatorcontrib>Domon, Hiroka</creatorcontrib><creatorcontrib>Hareyama, Hitoshi</creatorcontrib><creatorcontrib>Sato, Chikara</creatorcontrib><creatorcontrib>Fujino, Takahumi</creatorcontrib><creatorcontrib>Kawaguchi, Isao</creatorcontrib><creatorcontrib>Yamaguchi, Tatsumi</creatorcontrib><creatorcontrib>Fujimoto, Toshio</creatorcontrib><creatorcontrib>Yoshiaki, Ken</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Nucleic Acids Abstracts</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Biotechnology and BioEngineering Abstracts</collection><jtitle>Japanese journal of clinical oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Yamamoto, Ritsu</au><au>Minobe, Shinichiro</au><au>Kaneuchi, Masanori</au><au>Sakuragi, Noriaki</au><au>Fujimoto, Seiichiro</au><au>Ishizaki, Yoshiaki</au><au>Domon, Hiroka</au><au>Hareyama, Hitoshi</au><au>Sato, Chikara</au><au>Fujino, Takahumi</au><au>Kawaguchi, Isao</au><au>Yamaguchi, Tatsumi</au><au>Fujimoto, Toshio</au><au>Yoshiaki, Ken</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Phase I/II Study of Carboplatin and Paclitaxel in Patients with Epithelial Ovarian Cancer</atitle><jtitle>Japanese journal of clinical oncology</jtitle><addtitle>JJCO</addtitle><date>2002-04-01</date><risdate>2002</risdate><volume>32</volume><issue>4</issue><spage>128</spage><epage>134</epage><pages>128-134</pages><issn>0368-2811</issn><issn>1465-3621</issn><eissn>1465-3621</eissn><abstract>Background: This study was conducted to investigate the recommended dose of paclitaxel for use in combination with a fixed dose of carboplatin and to evaluate the toxicity and efficacy of carboplatin–paclitaxel combination chemotherapy in patients with epithelial ovarian cancer. Methods: One hundred and ten patients were enrolled in the Phase I/II study and 97 patients were evaluated for further analysis, excluding 13 ineligible patients or patients with infringement of protocol: 15 patients for the Phase I and 82 for the Phase II study. In the Phase I trial, we studied dose escalation using a carboplatin dose of AUC 5 and paclitaxel levels of 150, 175 and 200 mg/m2. The grades of toxicity of the regimen of all patients enrolled in the Phase II study (n = 82), the progression-free survival time (PFS) of optimal-debulked patients and complete responders (n = 62) and the response rate of suboptimal-debulked patients (n = 39) were investigated. Results: After observing grade 4 neutropenia in four of six patients in the paclitaxel 200 mg/m2 administration group, we chose 175 mg/m2 as the recommended dose of paclitaxel in this regimen. At this dose, the median of PFS and response rate were 432 days (range, 19–907 days) and 66.7%, respectively. Conclusion: Combination chemotherapy using paclitaxel 175 mg/m2 and carboplatin AUC 5 is very well tolerated and highly effective for the treatment of ovarian cancer.</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>12072422</pmid><doi>10.1093/jjco/hyf029</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Japanese journal of clinical oncology, 2002-04, Vol.32 (4), p.128-134 |
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| subjects | Adult Aged Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Carboplatin - administration & dosage Carcinoma - drug therapy Dose-Response Relationship, Drug Drug Administration Schedule Female Hematologic Diseases - chemically induced Humans Key words: carboplatin – ovarian cancer – paclitaxel Middle Aged Ovarian cancer Ovarian Neoplasms - drug therapy Paclitaxel - administration & dosage |
| title | A Phase I/II Study of Carboplatin and Paclitaxel in Patients with Epithelial Ovarian Cancer |
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