Phase I dose-escalation study of cabazitaxel administered in combination with cisplatin in patients with advanced solid tumors
Summary Introduction Cabazitaxel is a second-generation taxane with in vivo activity against taxane-sensitive and -resistant tumor cell lines and tumor xenografts. Cabazitaxel/cisplatin have therapeutic synergism in tumor-bearing mice, providing a rationale for assessing this combination in patients...
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Veröffentlicht in: | Investigational new drugs 2014-12, Vol.32 (6), p.1236-1245 |
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creator | Lockhart, A. Craig Sundaram, Shankar Sarantopoulos, John Mita, Monica M. Wang-Gillam, Andrea Moseley, Jennifer L. Barber, Stephanie L. Lane, Alex R. Wack, Claudine Kassalow, Laurent Dedieu, Jean-François Mita, Alain C. |
description | Summary
Introduction
Cabazitaxel is a second-generation taxane with in vivo activity against taxane-sensitive and -resistant tumor cell lines and tumor xenografts. Cabazitaxel/cisplatin have therapeutic synergism in tumor-bearing mice, providing a rationale for assessing this combination in patients with solid tumors.
Methods
The primary objectives of this study were to determine dose-limiting toxicities (DLTs) and the maximum tolerated dose (MTD) of a cabazitaxel/cisplatin combined regimen (Part 1) and to assess antitumor activity at the MTD (Part 2). Safety and pharmacokinetics (PK) were also examined.
Results
Twenty-five patients with advanced solid tumors were enrolled (10 in Part 1; 15 in Part 2). In Part 1, two dose levels were evaluated; the MTD for cabazitaxel/cisplatin (given Q3W) was 15/75 mg/m
2
. DLTs occurring during Cycle 1 at the maximum administered dose (20/75 mg/m
2
; acute renal failure and febrile neutropenia) and the MTD (febrile neutropenia and hypersensitivity despite pre-medication) were as expected for taxane/platinum combinations. For the 18 patients treated at the MTD, the most frequent possibly related non-hematologic treatment-emergent adverse events (Grade ≥3) were nausea (16.7 %), fatigue, acute renal failure and decreased appetite (each 11.1 %). Neutropenia was the most frequent treatment-emergent Grade ≥3 hematologic laboratory abnormality at the MTD (77.8 %). The best overall response at the MTD was stable disease, observed in 66.7 % of patients. PK results of the combination did not appear to differ from single-agent administration for each agent.
Conclusion
Combination treatment with cabazitaxel/cisplatin had a manageable safety profile; no PK interactions were evident. The recommended Phase II dose for this combination is cabazitaxel/cisplatin 15/75 mg/m
2
administered every 3 weeks. Antitumor activity findings suggest that further evaluation of this combination in disease-specific trials is warranted. |
doi_str_mv | 10.1007/s10637-014-0145-y |
format | Article |
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Introduction
Cabazitaxel is a second-generation taxane with in vivo activity against taxane-sensitive and -resistant tumor cell lines and tumor xenografts. Cabazitaxel/cisplatin have therapeutic synergism in tumor-bearing mice, providing a rationale for assessing this combination in patients with solid tumors.
Methods
The primary objectives of this study were to determine dose-limiting toxicities (DLTs) and the maximum tolerated dose (MTD) of a cabazitaxel/cisplatin combined regimen (Part 1) and to assess antitumor activity at the MTD (Part 2). Safety and pharmacokinetics (PK) were also examined.
Results
Twenty-five patients with advanced solid tumors were enrolled (10 in Part 1; 15 in Part 2). In Part 1, two dose levels were evaluated; the MTD for cabazitaxel/cisplatin (given Q3W) was 15/75 mg/m
2
. DLTs occurring during Cycle 1 at the maximum administered dose (20/75 mg/m
2
; acute renal failure and febrile neutropenia) and the MTD (febrile neutropenia and hypersensitivity despite pre-medication) were as expected for taxane/platinum combinations. For the 18 patients treated at the MTD, the most frequent possibly related non-hematologic treatment-emergent adverse events (Grade ≥3) were nausea (16.7 %), fatigue, acute renal failure and decreased appetite (each 11.1 %). Neutropenia was the most frequent treatment-emergent Grade ≥3 hematologic laboratory abnormality at the MTD (77.8 %). The best overall response at the MTD was stable disease, observed in 66.7 % of patients. PK results of the combination did not appear to differ from single-agent administration for each agent.
Conclusion
Combination treatment with cabazitaxel/cisplatin had a manageable safety profile; no PK interactions were evident. The recommended Phase II dose for this combination is cabazitaxel/cisplatin 15/75 mg/m
2
administered every 3 weeks. Antitumor activity findings suggest that further evaluation of this combination in disease-specific trials is warranted.</description><identifier>ISSN: 0167-6997</identifier><identifier>EISSN: 1573-0646</identifier><identifier>DOI: 10.1007/s10637-014-0145-y</identifier><identifier>PMID: 25117475</identifier><identifier>CODEN: INNDDK</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Adult ; Aged ; Antineoplastic agents ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - pharmacokinetics ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biological and medical sciences ; Cancer therapies ; Chemotherapy ; Cisplatin - administration & dosage ; Cisplatin - adverse effects ; Cisplatin - pharmacokinetics ; Clinical trials ; Creatinine ; Drug dosages ; Female ; Humans ; Kaplan-Meier Estimate ; Kidney diseases ; Male ; Maximum Tolerated Dose ; Medical sciences ; Medicine ; Medicine & Public Health ; Middle Aged ; Multiple tumors. Solid tumors. Tumors in childhood (general aspects) ; Neoplasms - drug therapy ; Neoplasms - metabolism ; Neutropenia ; Oncology ; Patients ; Pharmaceutical sciences ; Pharmacokinetics ; Pharmacology. Drug treatments ; Pharmacology/Toxicology ; Phase I Studies ; Phosphatase ; Response Evaluation Criteria in Solid Tumors ; Signal transduction ; Studies ; Taxoids - administration & dosage ; Taxoids - adverse effects ; Taxoids - pharmacokinetics ; Toxicity ; Tumors</subject><ispartof>Investigational new drugs, 2014-12, Vol.32 (6), p.1236-1245</ispartof><rights>Springer Science+Business Media New York 2014</rights><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c402t-faf9385746c4115a2737304967c819be314774ff955ede60cda81a7034f78eed3</citedby><cites>FETCH-LOGICAL-c402t-faf9385746c4115a2737304967c819be314774ff955ede60cda81a7034f78eed3</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/s10637-014-0145-y$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10637-014-0145-y$$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&idt=29026934$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25117475$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lockhart, A. Craig</creatorcontrib><creatorcontrib>Sundaram, Shankar</creatorcontrib><creatorcontrib>Sarantopoulos, John</creatorcontrib><creatorcontrib>Mita, Monica M.</creatorcontrib><creatorcontrib>Wang-Gillam, Andrea</creatorcontrib><creatorcontrib>Moseley, Jennifer L.</creatorcontrib><creatorcontrib>Barber, Stephanie L.</creatorcontrib><creatorcontrib>Lane, Alex R.</creatorcontrib><creatorcontrib>Wack, Claudine</creatorcontrib><creatorcontrib>Kassalow, Laurent</creatorcontrib><creatorcontrib>Dedieu, Jean-François</creatorcontrib><creatorcontrib>Mita, Alain C.</creatorcontrib><title>Phase I dose-escalation study of cabazitaxel administered in combination with cisplatin in patients with advanced solid tumors</title><title>Investigational new drugs</title><addtitle>Invest New Drugs</addtitle><addtitle>Invest New Drugs</addtitle><description>Summary
Introduction
Cabazitaxel is a second-generation taxane with in vivo activity against taxane-sensitive and -resistant tumor cell lines and tumor xenografts. Cabazitaxel/cisplatin have therapeutic synergism in tumor-bearing mice, providing a rationale for assessing this combination in patients with solid tumors.
Methods
The primary objectives of this study were to determine dose-limiting toxicities (DLTs) and the maximum tolerated dose (MTD) of a cabazitaxel/cisplatin combined regimen (Part 1) and to assess antitumor activity at the MTD (Part 2). Safety and pharmacokinetics (PK) were also examined.
Results
Twenty-five patients with advanced solid tumors were enrolled (10 in Part 1; 15 in Part 2). In Part 1, two dose levels were evaluated; the MTD for cabazitaxel/cisplatin (given Q3W) was 15/75 mg/m
2
. DLTs occurring during Cycle 1 at the maximum administered dose (20/75 mg/m
2
; acute renal failure and febrile neutropenia) and the MTD (febrile neutropenia and hypersensitivity despite pre-medication) were as expected for taxane/platinum combinations. For the 18 patients treated at the MTD, the most frequent possibly related non-hematologic treatment-emergent adverse events (Grade ≥3) were nausea (16.7 %), fatigue, acute renal failure and decreased appetite (each 11.1 %). Neutropenia was the most frequent treatment-emergent Grade ≥3 hematologic laboratory abnormality at the MTD (77.8 %). The best overall response at the MTD was stable disease, observed in 66.7 % of patients. PK results of the combination did not appear to differ from single-agent administration for each agent.
Conclusion
Combination treatment with cabazitaxel/cisplatin had a manageable safety profile; no PK interactions were evident. The recommended Phase II dose for this combination is cabazitaxel/cisplatin 15/75 mg/m
2
administered every 3 weeks. Antitumor activity findings suggest that further evaluation of this combination in disease-specific trials is warranted.</description><subject>Adult</subject><subject>Aged</subject><subject>Antineoplastic agents</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - pharmacokinetics</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Cancer therapies</subject><subject>Chemotherapy</subject><subject>Cisplatin - administration & dosage</subject><subject>Cisplatin - adverse effects</subject><subject>Cisplatin - pharmacokinetics</subject><subject>Clinical trials</subject><subject>Creatinine</subject><subject>Drug dosages</subject><subject>Female</subject><subject>Humans</subject><subject>Kaplan-Meier Estimate</subject><subject>Kidney diseases</subject><subject>Male</subject><subject>Maximum Tolerated Dose</subject><subject>Medical sciences</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Multiple tumors. Solid tumors. Tumors in childhood (general aspects)</subject><subject>Neoplasms - drug therapy</subject><subject>Neoplasms - metabolism</subject><subject>Neutropenia</subject><subject>Oncology</subject><subject>Patients</subject><subject>Pharmaceutical sciences</subject><subject>Pharmacokinetics</subject><subject>Pharmacology. Drug treatments</subject><subject>Pharmacology/Toxicology</subject><subject>Phase I Studies</subject><subject>Phosphatase</subject><subject>Response Evaluation Criteria in Solid Tumors</subject><subject>Signal transduction</subject><subject>Studies</subject><subject>Taxoids - administration & dosage</subject><subject>Taxoids - adverse effects</subject><subject>Taxoids - pharmacokinetics</subject><subject>Toxicity</subject><subject>Tumors</subject><issn>0167-6997</issn><issn>1573-0646</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp1kEuLFDEUhYMoTs_oD3AjAXFZmnc6SxlGHRjQha6LdB5Ohq6kzU05tgt_uymqfWxcXBI43zn3chB6RskrSoh-DZQorgdCxTJyOD5AGyo1H4gS6iHaEKr0oIzRZ-gc4I4Qwo0Wj9EZk5RqoeUG_fx4ayHga-wLhCGAs3vbUskY2uyPuETs7M7-SM1-D3ts_ZRyghZq8Dhl7Mq0S3k13Kd2i12CwxKQF_XQPyE3WCXrv9nsug_KPnnc5qlUeIIeRbuH8PT0XqDPb68-Xb4fbj68u758czM4QVgboo2Gb6UWyglKpWWaa06EUdptqdkFToXWIkYjZfBBEeftllpNuIh6G4LnF-jFmnuo5escoI13Za65rxypYowRySnrFF0pVwtADXE81DTZehwpGZfGx7Xxsbe9jByP3fP8lDzvpuD_OH5X3IGXJ8Au7cbaW0jwlzOEKcNF59jKQZfyl1D_OfG_238Bbq-apQ</recordid><startdate>20141201</startdate><enddate>20141201</enddate><creator>Lockhart, A. Craig</creator><creator>Sundaram, Shankar</creator><creator>Sarantopoulos, John</creator><creator>Mita, Monica M.</creator><creator>Wang-Gillam, Andrea</creator><creator>Moseley, Jennifer L.</creator><creator>Barber, Stephanie L.</creator><creator>Lane, Alex R.</creator><creator>Wack, Claudine</creator><creator>Kassalow, Laurent</creator><creator>Dedieu, Jean-François</creator><creator>Mita, Alain C.</creator><general>Springer US</general><general>Springer</general><general>Springer Nature B.V</general><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>7QO</scope><scope>7RV</scope><scope>7WY</scope><scope>7WZ</scope><scope>7X7</scope><scope>7XB</scope><scope>87Z</scope><scope>88E</scope><scope>8AO</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8FL</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>BEZIV</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FRNLG</scope><scope>FYUFA</scope><scope>F~G</scope><scope>GHDGH</scope><scope>K60</scope><scope>K6~</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>L.-</scope><scope>M0C</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQBIZ</scope><scope>PQBZA</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope></search><sort><creationdate>20141201</creationdate><title>Phase I dose-escalation study of cabazitaxel administered in combination with cisplatin in patients with advanced solid tumors</title><author>Lockhart, A. Craig ; Sundaram, Shankar ; Sarantopoulos, John ; Mita, Monica M. ; Wang-Gillam, Andrea ; Moseley, Jennifer L. ; Barber, Stephanie L. ; Lane, Alex R. ; Wack, Claudine ; Kassalow, Laurent ; Dedieu, Jean-François ; Mita, Alain C.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c402t-faf9385746c4115a2737304967c819be314774ff955ede60cda81a7034f78eed3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Antineoplastic agents</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - pharmacokinetics</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Cancer therapies</topic><topic>Chemotherapy</topic><topic>Cisplatin - administration & dosage</topic><topic>Cisplatin - adverse effects</topic><topic>Cisplatin - pharmacokinetics</topic><topic>Clinical trials</topic><topic>Creatinine</topic><topic>Drug dosages</topic><topic>Female</topic><topic>Humans</topic><topic>Kaplan-Meier Estimate</topic><topic>Kidney diseases</topic><topic>Male</topic><topic>Maximum Tolerated Dose</topic><topic>Medical sciences</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Multiple tumors. Solid tumors. Tumors in childhood (general aspects)</topic><topic>Neoplasms - drug therapy</topic><topic>Neoplasms - metabolism</topic><topic>Neutropenia</topic><topic>Oncology</topic><topic>Patients</topic><topic>Pharmaceutical sciences</topic><topic>Pharmacokinetics</topic><topic>Pharmacology. Drug treatments</topic><topic>Pharmacology/Toxicology</topic><topic>Phase I Studies</topic><topic>Phosphatase</topic><topic>Response Evaluation Criteria in Solid Tumors</topic><topic>Signal transduction</topic><topic>Studies</topic><topic>Taxoids - administration & dosage</topic><topic>Taxoids - adverse effects</topic><topic>Taxoids - pharmacokinetics</topic><topic>Toxicity</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lockhart, A. Craig</creatorcontrib><creatorcontrib>Sundaram, Shankar</creatorcontrib><creatorcontrib>Sarantopoulos, John</creatorcontrib><creatorcontrib>Mita, Monica M.</creatorcontrib><creatorcontrib>Wang-Gillam, Andrea</creatorcontrib><creatorcontrib>Moseley, Jennifer L.</creatorcontrib><creatorcontrib>Barber, Stephanie L.</creatorcontrib><creatorcontrib>Lane, Alex R.</creatorcontrib><creatorcontrib>Wack, Claudine</creatorcontrib><creatorcontrib>Kassalow, Laurent</creatorcontrib><creatorcontrib>Dedieu, Jean-François</creatorcontrib><creatorcontrib>Mita, Alain C.</creatorcontrib><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>Biotechnology Research Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>ABI/INFORM Collection</collection><collection>ABI/INFORM Global (PDF only)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>ABI/INFORM Global (Alumni Edition)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ABI/INFORM Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>Business Premium Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Business Premium Collection (Alumni)</collection><collection>Health Research Premium Collection</collection><collection>ABI/INFORM Global (Corporate)</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Business Collection (Alumni Edition)</collection><collection>ProQuest Business Collection</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ABI/INFORM Professional Advanced</collection><collection>ABI/INFORM Global</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Business</collection><collection>ProQuest One Business (Alumni)</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 Basic</collection><jtitle>Investigational new drugs</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lockhart, A. Craig</au><au>Sundaram, Shankar</au><au>Sarantopoulos, John</au><au>Mita, Monica M.</au><au>Wang-Gillam, Andrea</au><au>Moseley, Jennifer L.</au><au>Barber, Stephanie L.</au><au>Lane, Alex R.</au><au>Wack, Claudine</au><au>Kassalow, Laurent</au><au>Dedieu, Jean-François</au><au>Mita, Alain C.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase I dose-escalation study of cabazitaxel administered in combination with cisplatin in patients with advanced solid tumors</atitle><jtitle>Investigational new drugs</jtitle><stitle>Invest New Drugs</stitle><addtitle>Invest New Drugs</addtitle><date>2014-12-01</date><risdate>2014</risdate><volume>32</volume><issue>6</issue><spage>1236</spage><epage>1245</epage><pages>1236-1245</pages><issn>0167-6997</issn><eissn>1573-0646</eissn><coden>INNDDK</coden><abstract>Summary
Introduction
Cabazitaxel is a second-generation taxane with in vivo activity against taxane-sensitive and -resistant tumor cell lines and tumor xenografts. Cabazitaxel/cisplatin have therapeutic synergism in tumor-bearing mice, providing a rationale for assessing this combination in patients with solid tumors.
Methods
The primary objectives of this study were to determine dose-limiting toxicities (DLTs) and the maximum tolerated dose (MTD) of a cabazitaxel/cisplatin combined regimen (Part 1) and to assess antitumor activity at the MTD (Part 2). Safety and pharmacokinetics (PK) were also examined.
Results
Twenty-five patients with advanced solid tumors were enrolled (10 in Part 1; 15 in Part 2). In Part 1, two dose levels were evaluated; the MTD for cabazitaxel/cisplatin (given Q3W) was 15/75 mg/m
2
. DLTs occurring during Cycle 1 at the maximum administered dose (20/75 mg/m
2
; acute renal failure and febrile neutropenia) and the MTD (febrile neutropenia and hypersensitivity despite pre-medication) were as expected for taxane/platinum combinations. For the 18 patients treated at the MTD, the most frequent possibly related non-hematologic treatment-emergent adverse events (Grade ≥3) were nausea (16.7 %), fatigue, acute renal failure and decreased appetite (each 11.1 %). Neutropenia was the most frequent treatment-emergent Grade ≥3 hematologic laboratory abnormality at the MTD (77.8 %). The best overall response at the MTD was stable disease, observed in 66.7 % of patients. PK results of the combination did not appear to differ from single-agent administration for each agent.
Conclusion
Combination treatment with cabazitaxel/cisplatin had a manageable safety profile; no PK interactions were evident. The recommended Phase II dose for this combination is cabazitaxel/cisplatin 15/75 mg/m
2
administered every 3 weeks. Antitumor activity findings suggest that further evaluation of this combination in disease-specific trials is warranted.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>25117475</pmid><doi>10.1007/s10637-014-0145-y</doi><tpages>10</tpages></addata></record> |
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subjects | Adult Aged Antineoplastic agents Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - pharmacokinetics Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biological and medical sciences Cancer therapies Chemotherapy Cisplatin - administration & dosage Cisplatin - adverse effects Cisplatin - pharmacokinetics Clinical trials Creatinine Drug dosages Female Humans Kaplan-Meier Estimate Kidney diseases Male Maximum Tolerated Dose Medical sciences Medicine Medicine & Public Health Middle Aged Multiple tumors. Solid tumors. Tumors in childhood (general aspects) Neoplasms - drug therapy Neoplasms - metabolism Neutropenia Oncology Patients Pharmaceutical sciences Pharmacokinetics Pharmacology. Drug treatments Pharmacology/Toxicology Phase I Studies Phosphatase Response Evaluation Criteria in Solid Tumors Signal transduction Studies Taxoids - administration & dosage Taxoids - adverse effects Taxoids - pharmacokinetics Toxicity Tumors |
title | Phase I dose-escalation study of cabazitaxel administered in combination with cisplatin in patients with advanced solid tumors |
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