A phase I study of TNP-470 administered to patients with advanced squamous cell cancer of the cervix
A Phase I study of the novel angiogenesis inhibitor TNP-470 was performed. Patients with inoperable recurring or metastatic squamous cell cancer of the cervix with evaluable disease, no coagulopathy, and adequate renal, hepatic, and hematological function were eligible. One course of treatment consi...
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| Veröffentlicht in: | Clinical cancer research 1997-09, Vol.3 (9), p.1501-1505 |
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| creator | KUDELKA, A. P LEVY, T JAECKLE, K. A LOYER, E STEGER, M MANTE, R MAVLIGIT, G KILLIAN, A TANG, R. A GUTTERMAN, J. U KAVANAGH, J. J VERSCHRAEGEN, C. F EDWARDS, C. L PIAMSOMBOON, S TERMRUNGRUANGLERT, W FREEDMAN, R. S KAPLAN, A. L KIEBACK, D. G MEYERS, C. A |
| description | A Phase I study of the novel angiogenesis inhibitor TNP-470 was performed. Patients with inoperable recurring or metastatic
squamous cell cancer of the cervix with evaluable disease, no coagulopathy, and adequate renal, hepatic, and hematological
function were eligible. One course of treatment consisted of an i.v. infusion of TNP-470 over 60 min every other day for 28
days, followed by a 14-day rest period. The starting dose was 9.3 mg/m2. Eighteen evaluable patients were treated, with a
median age of 48 years (range 27-55) and performance status Zubrod 1 (range 0-2). Grade 3 neurotoxicities consisting of weakness,
nystagmus, diplopia, and ataxia were encountered in two patients receiving the 71.2 mg/m2 dose. An intermediate dose level
of 60 mg/m2 was evaluated and found to be well tolerated by three patients. Only one patient experienced grade 3 nausea on
the 60 mg/m2 dose level. No myelosuppression, retinal hemorrhage, weight loss, or significant alopecia were observed. One
patient had a complete response, which continues for 26 months, and three patients with initially progressive disease stage
had stable disease for 5, 7.7, and 19+ months. Other Phase I studies, including over 200 patients, were performed concurrently
with this study. Based on this experience, the dose of TNP-470 recommended for further studies is 60 mg/m2 as a 60-min i.v.
infusion every Monday, Wednesday, and Friday. Neurotoxicity was dose limiting, but appears to be reversible. Otherwise, the
treatment was well tolerated. The drug may be active in squamous cell cancer of the cervix. Further studies of TNP-470 in
squamous cell cancer of the cervix are warranted. |
| format | Article |
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squamous cell cancer of the cervix with evaluable disease, no coagulopathy, and adequate renal, hepatic, and hematological
function were eligible. One course of treatment consisted of an i.v. infusion of TNP-470 over 60 min every other day for 28
days, followed by a 14-day rest period. The starting dose was 9.3 mg/m2. Eighteen evaluable patients were treated, with a
median age of 48 years (range 27-55) and performance status Zubrod 1 (range 0-2). Grade 3 neurotoxicities consisting of weakness,
nystagmus, diplopia, and ataxia were encountered in two patients receiving the 71.2 mg/m2 dose. An intermediate dose level
of 60 mg/m2 was evaluated and found to be well tolerated by three patients. Only one patient experienced grade 3 nausea on
the 60 mg/m2 dose level. No myelosuppression, retinal hemorrhage, weight loss, or significant alopecia were observed. One
patient had a complete response, which continues for 26 months, and three patients with initially progressive disease stage
had stable disease for 5, 7.7, and 19+ months. Other Phase I studies, including over 200 patients, were performed concurrently
with this study. Based on this experience, the dose of TNP-470 recommended for further studies is 60 mg/m2 as a 60-min i.v.
infusion every Monday, Wednesday, and Friday. Neurotoxicity was dose limiting, but appears to be reversible. Otherwise, the
treatment was well tolerated. The drug may be active in squamous cell cancer of the cervix. Further studies of TNP-470 in
squamous cell cancer of the cervix are warranted.</description><identifier>ISSN: 1078-0432</identifier><identifier>EISSN: 1557-3265</identifier><identifier>PMID: 9815836</identifier><language>eng</language><publisher>Philadelphia, PA: American Association for Cancer Research</publisher><subject>Adult ; Antibiotics, Antineoplastic - administration & dosage ; Antibiotics, Antineoplastic - adverse effects ; Antibiotics, Antineoplastic - therapeutic use ; Antineoplastic agents ; Biological and medical sciences ; Carcinoma, Squamous Cell - drug therapy ; Carcinoma, Squamous Cell - pathology ; Carcinoma, Squamous Cell - therapy ; Chemotherapy ; Combined Modality Therapy ; Cyclohexanes ; Dose-Response Relationship, Drug ; Female ; Humans ; Infusions, Intravenous ; Medical sciences ; Middle Aged ; Nausea - chemically induced ; Neovascularization, Pathologic - drug therapy ; Nervous System Diseases - chemically induced ; Pharmacology. Drug treatments ; Salvage Therapy ; Sesquiterpenes - administration & dosage ; Sesquiterpenes - adverse effects ; Sesquiterpenes - therapeutic use ; Treatment Outcome ; Uterine Cervical Neoplasms - drug therapy ; Uterine Cervical Neoplasms - pathology ; Uterine Cervical Neoplasms - therapy</subject><ispartof>Clinical cancer research, 1997-09, Vol.3 (9), p.1501-1505</ispartof><rights>1997 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=2812015$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/9815836$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>KUDELKA, A. P</creatorcontrib><creatorcontrib>LEVY, T</creatorcontrib><creatorcontrib>JAECKLE, K. A</creatorcontrib><creatorcontrib>LOYER, E</creatorcontrib><creatorcontrib>STEGER, M</creatorcontrib><creatorcontrib>MANTE, R</creatorcontrib><creatorcontrib>MAVLIGIT, G</creatorcontrib><creatorcontrib>KILLIAN, A</creatorcontrib><creatorcontrib>TANG, R. A</creatorcontrib><creatorcontrib>GUTTERMAN, J. U</creatorcontrib><creatorcontrib>KAVANAGH, J. J</creatorcontrib><creatorcontrib>VERSCHRAEGEN, C. F</creatorcontrib><creatorcontrib>EDWARDS, C. L</creatorcontrib><creatorcontrib>PIAMSOMBOON, S</creatorcontrib><creatorcontrib>TERMRUNGRUANGLERT, W</creatorcontrib><creatorcontrib>FREEDMAN, R. S</creatorcontrib><creatorcontrib>KAPLAN, A. L</creatorcontrib><creatorcontrib>KIEBACK, D. G</creatorcontrib><creatorcontrib>MEYERS, C. A</creatorcontrib><title>A phase I study of TNP-470 administered to patients with advanced squamous cell cancer of the cervix</title><title>Clinical cancer research</title><addtitle>Clin Cancer Res</addtitle><description>A Phase I study of the novel angiogenesis inhibitor TNP-470 was performed. Patients with inoperable recurring or metastatic
squamous cell cancer of the cervix with evaluable disease, no coagulopathy, and adequate renal, hepatic, and hematological
function were eligible. One course of treatment consisted of an i.v. infusion of TNP-470 over 60 min every other day for 28
days, followed by a 14-day rest period. The starting dose was 9.3 mg/m2. Eighteen evaluable patients were treated, with a
median age of 48 years (range 27-55) and performance status Zubrod 1 (range 0-2). Grade 3 neurotoxicities consisting of weakness,
nystagmus, diplopia, and ataxia were encountered in two patients receiving the 71.2 mg/m2 dose. An intermediate dose level
of 60 mg/m2 was evaluated and found to be well tolerated by three patients. Only one patient experienced grade 3 nausea on
the 60 mg/m2 dose level. No myelosuppression, retinal hemorrhage, weight loss, or significant alopecia were observed. One
patient had a complete response, which continues for 26 months, and three patients with initially progressive disease stage
had stable disease for 5, 7.7, and 19+ months. Other Phase I studies, including over 200 patients, were performed concurrently
with this study. Based on this experience, the dose of TNP-470 recommended for further studies is 60 mg/m2 as a 60-min i.v.
infusion every Monday, Wednesday, and Friday. Neurotoxicity was dose limiting, but appears to be reversible. Otherwise, the
treatment was well tolerated. The drug may be active in squamous cell cancer of the cervix. Further studies of TNP-470 in
squamous cell cancer of the cervix are warranted.</description><subject>Adult</subject><subject>Antibiotics, Antineoplastic - administration & dosage</subject><subject>Antibiotics, Antineoplastic - adverse effects</subject><subject>Antibiotics, Antineoplastic - therapeutic use</subject><subject>Antineoplastic agents</subject><subject>Biological and medical sciences</subject><subject>Carcinoma, Squamous Cell - drug therapy</subject><subject>Carcinoma, Squamous Cell - pathology</subject><subject>Carcinoma, Squamous Cell - therapy</subject><subject>Chemotherapy</subject><subject>Combined Modality Therapy</subject><subject>Cyclohexanes</subject><subject>Dose-Response Relationship, Drug</subject><subject>Female</subject><subject>Humans</subject><subject>Infusions, Intravenous</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Nausea - chemically induced</subject><subject>Neovascularization, Pathologic - drug therapy</subject><subject>Nervous System Diseases - chemically induced</subject><subject>Pharmacology. Drug treatments</subject><subject>Salvage Therapy</subject><subject>Sesquiterpenes - administration & dosage</subject><subject>Sesquiterpenes - adverse effects</subject><subject>Sesquiterpenes - therapeutic use</subject><subject>Treatment Outcome</subject><subject>Uterine Cervical Neoplasms - drug therapy</subject><subject>Uterine Cervical Neoplasms - pathology</subject><subject>Uterine Cervical Neoplasms - therapy</subject><issn>1078-0432</issn><issn>1557-3265</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1997</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo9j11LwzAYhYMoc05_gpALwatC3qRt0ssx_BgM9WJelzQfNtJuNUk39-_N2PDqfTnP4XDOBZpCUfCM0bK4TD_hIiM5o9foJoRvQiAHkk_QpBJQCFZOkZ7joZXB4CUOcdQHvLV4_faR5ZxgqXu3cSEabzSOWzzI6MwmBrx3sU10JzcqkfAzyn47BqxM12F1FP0xJrYmSX7nfm_RlZVdMHfnO0Ofz0_rxWu2en9ZLuarrKUljxmzjBNhCUnNLNgGZFnm0FClLCjGqNVghGGN0lQ3NBek4VwJC6KCigOt2Azdn3KHsemNrgfveukP9Xlt4g9nLoOSnfWpqwv_NiqAEiiS7fFka91Xu3fe1KdR3gQjvWprVlc1FATYH9mXa4U</recordid><startdate>19970901</startdate><enddate>19970901</enddate><creator>KUDELKA, A. P</creator><creator>LEVY, T</creator><creator>JAECKLE, K. A</creator><creator>LOYER, E</creator><creator>STEGER, M</creator><creator>MANTE, R</creator><creator>MAVLIGIT, G</creator><creator>KILLIAN, A</creator><creator>TANG, R. A</creator><creator>GUTTERMAN, J. U</creator><creator>KAVANAGH, J. J</creator><creator>VERSCHRAEGEN, C. F</creator><creator>EDWARDS, C. L</creator><creator>PIAMSOMBOON, S</creator><creator>TERMRUNGRUANGLERT, W</creator><creator>FREEDMAN, R. S</creator><creator>KAPLAN, A. L</creator><creator>KIEBACK, D. G</creator><creator>MEYERS, C. A</creator><general>American Association for Cancer Research</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope></search><sort><creationdate>19970901</creationdate><title>A phase I study of TNP-470 administered to patients with advanced squamous cell cancer of the cervix</title><author>KUDELKA, A. P ; LEVY, T ; JAECKLE, K. A ; LOYER, E ; STEGER, M ; MANTE, R ; MAVLIGIT, G ; KILLIAN, A ; TANG, R. A ; GUTTERMAN, J. U ; KAVANAGH, J. J ; VERSCHRAEGEN, C. F ; EDWARDS, C. L ; PIAMSOMBOON, S ; TERMRUNGRUANGLERT, W ; FREEDMAN, R. S ; KAPLAN, A. L ; KIEBACK, D. G ; MEYERS, C. 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Drug treatments</topic><topic>Salvage Therapy</topic><topic>Sesquiterpenes - administration & dosage</topic><topic>Sesquiterpenes - adverse effects</topic><topic>Sesquiterpenes - therapeutic use</topic><topic>Treatment Outcome</topic><topic>Uterine Cervical Neoplasms - drug therapy</topic><topic>Uterine Cervical Neoplasms - pathology</topic><topic>Uterine Cervical Neoplasms - therapy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>KUDELKA, A. P</creatorcontrib><creatorcontrib>LEVY, T</creatorcontrib><creatorcontrib>JAECKLE, K. A</creatorcontrib><creatorcontrib>LOYER, E</creatorcontrib><creatorcontrib>STEGER, M</creatorcontrib><creatorcontrib>MANTE, R</creatorcontrib><creatorcontrib>MAVLIGIT, G</creatorcontrib><creatorcontrib>KILLIAN, A</creatorcontrib><creatorcontrib>TANG, R. A</creatorcontrib><creatorcontrib>GUTTERMAN, J. U</creatorcontrib><creatorcontrib>KAVANAGH, J. J</creatorcontrib><creatorcontrib>VERSCHRAEGEN, C. F</creatorcontrib><creatorcontrib>EDWARDS, C. L</creatorcontrib><creatorcontrib>PIAMSOMBOON, S</creatorcontrib><creatorcontrib>TERMRUNGRUANGLERT, W</creatorcontrib><creatorcontrib>FREEDMAN, R. S</creatorcontrib><creatorcontrib>KAPLAN, A. L</creatorcontrib><creatorcontrib>KIEBACK, D. G</creatorcontrib><creatorcontrib>MEYERS, C. A</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><jtitle>Clinical cancer research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>KUDELKA, A. P</au><au>LEVY, T</au><au>JAECKLE, K. A</au><au>LOYER, E</au><au>STEGER, M</au><au>MANTE, R</au><au>MAVLIGIT, G</au><au>KILLIAN, A</au><au>TANG, R. A</au><au>GUTTERMAN, J. U</au><au>KAVANAGH, J. J</au><au>VERSCHRAEGEN, C. F</au><au>EDWARDS, C. L</au><au>PIAMSOMBOON, S</au><au>TERMRUNGRUANGLERT, W</au><au>FREEDMAN, R. S</au><au>KAPLAN, A. L</au><au>KIEBACK, D. G</au><au>MEYERS, C. A</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A phase I study of TNP-470 administered to patients with advanced squamous cell cancer of the cervix</atitle><jtitle>Clinical cancer research</jtitle><addtitle>Clin Cancer Res</addtitle><date>1997-09-01</date><risdate>1997</risdate><volume>3</volume><issue>9</issue><spage>1501</spage><epage>1505</epage><pages>1501-1505</pages><issn>1078-0432</issn><eissn>1557-3265</eissn><abstract>A Phase I study of the novel angiogenesis inhibitor TNP-470 was performed. Patients with inoperable recurring or metastatic
squamous cell cancer of the cervix with evaluable disease, no coagulopathy, and adequate renal, hepatic, and hematological
function were eligible. One course of treatment consisted of an i.v. infusion of TNP-470 over 60 min every other day for 28
days, followed by a 14-day rest period. The starting dose was 9.3 mg/m2. Eighteen evaluable patients were treated, with a
median age of 48 years (range 27-55) and performance status Zubrod 1 (range 0-2). Grade 3 neurotoxicities consisting of weakness,
nystagmus, diplopia, and ataxia were encountered in two patients receiving the 71.2 mg/m2 dose. An intermediate dose level
of 60 mg/m2 was evaluated and found to be well tolerated by three patients. Only one patient experienced grade 3 nausea on
the 60 mg/m2 dose level. No myelosuppression, retinal hemorrhage, weight loss, or significant alopecia were observed. One
patient had a complete response, which continues for 26 months, and three patients with initially progressive disease stage
had stable disease for 5, 7.7, and 19+ months. Other Phase I studies, including over 200 patients, were performed concurrently
with this study. Based on this experience, the dose of TNP-470 recommended for further studies is 60 mg/m2 as a 60-min i.v.
infusion every Monday, Wednesday, and Friday. Neurotoxicity was dose limiting, but appears to be reversible. Otherwise, the
treatment was well tolerated. The drug may be active in squamous cell cancer of the cervix. Further studies of TNP-470 in
squamous cell cancer of the cervix are warranted.</abstract><cop>Philadelphia, PA</cop><pub>American Association for Cancer Research</pub><pmid>9815836</pmid><tpages>5</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1078-0432 |
| ispartof | Clinical cancer research, 1997-09, Vol.3 (9), p.1501-1505 |
| issn | 1078-0432 1557-3265 |
| language | eng |
| recordid | cdi_pubmed_primary_9815836 |
| source | MEDLINE; American Association for Cancer Research; EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection |
| subjects | Adult Antibiotics, Antineoplastic - administration & dosage Antibiotics, Antineoplastic - adverse effects Antibiotics, Antineoplastic - therapeutic use Antineoplastic agents Biological and medical sciences Carcinoma, Squamous Cell - drug therapy Carcinoma, Squamous Cell - pathology Carcinoma, Squamous Cell - therapy Chemotherapy Combined Modality Therapy Cyclohexanes Dose-Response Relationship, Drug Female Humans Infusions, Intravenous Medical sciences Middle Aged Nausea - chemically induced Neovascularization, Pathologic - drug therapy Nervous System Diseases - chemically induced Pharmacology. Drug treatments Salvage Therapy Sesquiterpenes - administration & dosage Sesquiterpenes - adverse effects Sesquiterpenes - therapeutic use Treatment Outcome Uterine Cervical Neoplasms - drug therapy Uterine Cervical Neoplasms - pathology Uterine Cervical Neoplasms - therapy |
| title | A phase I study of TNP-470 administered to patients with advanced squamous cell cancer of the cervix |
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