A sensitive docetaxel assay in plasma by solid-phase extraction and high performance liquid chromatography-UV detection: validation and suitability in phase I clinical trial pharmacokinetics.

Abstract:

:We have developed a specific and sensitive method aiming at docetaxel (Taxotere) determination in plasma of treated patients. This involved solid-phase extraction of 1 ml of plasma onto carboxylic acid (CBA) grafted silica cartridges followed by reversed-phase liquid chromatography with UV detection. The best selectivity was obtained through the use of C18 Uptisphere as stationary phase. The low limit of quantitation obtained (LOQ: 5 ng/ml) allowed measurements of docetaxel up to 24 hours after one-hour infusions with low dosages of drug (60 mg/m2). The method was applied successfully to monitor docetaxel plasma levels within two protocols associating fixed dosages of either methotrexate or gemcitabine with escalating doses of Taxotere.

journal_name

Invest New Drugs

authors

Ardiet CJ,Tranchand B,Zanetta S,Guillot A,Bernard E,Peguy M,Rebattu P,Droz JP

doi

10.1023/a:1006327302041

subject

Has Abstract

pub_date

1999-01-01 00:00:00

pages

325-33

issue

4

eissn

0167-6997

issn

1573-0646

journal_volume

17

pub_type

临床试验,杂志文章
  • Phase II study of n-methylformamide (NSC 3051) and spirogermanium (NSC 192965) in the treatment of advanced small cell lung cancer.

    abstract::Fifty-four evaluable patients with SCLC previously treated with chemotherapy received either N-methylformamide or spirogermanium. There was one partial response to N-methylformamide. The median survival times for patients treated with N-MF and spirogermanium were 11.7 and 12.6 weeks respectively. Five patients treated...

    journal_title:Investigational new drugs

    pub_type: 临床试验,杂志文章

    doi:10.1007/BF00177255

    authors: Ettinger DS,Finkelstein DM,Abeloff MD,Chang YC,Smith TJ,Oken MM,Ruckdeschel JC

    更新日期:1990-05-01 00:00:00

  • Cytotoxicity of withaferin A in glioblastomas involves induction of an oxidative stress-mediated heat shock response while altering Akt/mTOR and MAPK signaling pathways.

    abstract::Withaferin A (WA), a steroidal lactone derived from the plant Vassobia breviflora, has been reported to have anti-proliferative, pro-apoptotic, and anti-angiogenic properties against cancer growth. In this study, we identified several key underlying mechanisms of anticancer action of WA in glioblastoma cells. WA was f...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/s10637-012-9888-5

    authors: Grogan PT,Sleder KD,Samadi AK,Zhang H,Timmermann BN,Cohen MS

    更新日期:2013-06-01 00:00:00

  • Phase II trial with oral idarubicin in advanced breast cancer.

    abstract::Idarubicin, a new analogue of daunorubicin, was administered to 27 patients with advanced breast cancer in a phase II trial. The drug was given orally at a dose of 30-35 mg/m2 every 3 weeks. Twenty-two patients were evaluable for response. All evaluable patients were previously treated with one or more chemotherapeuti...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/BF00172014

    authors: Lopez M,Di Lauro L,Papaldo P,Lazzaro B,Ganzina F,Di Pietro N

    更新日期:1986-01-01 00:00:00

  • A phase I study of DHP107, a mucoadhesive lipid form of oral paclitaxel, in patients with advanced solid tumors: crossover comparisons with intravenous paclitaxel.

    abstract:PURPOSE:This study investigated the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), and pharmacokinetic (PK) profiles of DHP107, a novel oral paclitaxel containing neither Cremophor EL nor P-glycoprotein (P-gp) inhibitor. PATIENTS AND METHODS:Patients with advanced solid tumors refractory to all standard t...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/s10637-012-9841-7

    authors: Hong YS,Kim KP,Lim HS,Bae KS,Ryu MH,Lee JL,Chang HM,Kang YK,Kim H,Kim TW

    更新日期:2013-06-01 00:00:00

  • A phase I study of intraperitoneal paclitaxel combined with gemcitabine plus nab-paclitaxel for pancreatic cancer with peritoneal metastasis.

    abstract:PURPOSE:A phase I study of intraperitoneal paclitaxel (ip PTX) combined with gemcitabine (GEM) plus nab-paclitaxel (nab-PTX) (GnP) was conducted to determine the maximum tolerated dose (MTD) and the recommended dose (RD) in pancreatic cancer patients with peritoneal metastasis in first-line setting. METHODS:Based on t...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/s10637-020-00982-7

    authors: Takahara N,Nakai Y,Ishigami H,Saito K,Sato T,Hakuta R,Ishigaki K,Saito T,Hamada T,Mizuno S,Kogure H,Yamashita H,Isayama H,Seto Y,Koike K

    更新日期:2020-08-08 00:00:00

  • A dose escalation, safety, and tolerability study of MN-029 in patients with advanced solid tumors.

    abstract:PURPOSE:To assess the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), safety, and tolerability of MN-209, a novel vascular disrupting agent, in patients with advanced solid tumors. STUDY DESIGN:MN-029 was administered weekly for three consecutive weeks out of four; two cycles were planned. Dose escalation ...

    journal_title:Investigational new drugs

    pub_type: 杂志文章,多中心研究

    doi:10.1007/s10637-009-9264-2

    authors: Traynor AM,Gordon MS,Alberti D,Mendelson DS,Munsey MS,Wilding G,Gammans RE,Read WL

    更新日期:2010-08-01 00:00:00

  • Enhanced antitumor activity of irofulven in combination with antimitotic agents.

    abstract::The aim of this study was to determine the antitumor activity of irofulven when administered in combination with a variety of antimitotic agents. Irofulven in combination with either paclitaxel or docetaxel demonstrated synergistic activity in both the in vitro and in vivo studies. The majority of xenograft bearing an...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1023/a:1016201807796

    authors: Kelner MJ,McMorris TC,Rojas RJ,Trani NA,Velasco TR,Estes LA,Suthipinijtham P

    更新日期:2002-08-01 00:00:00

  • Phase 2 study of CT-322, a targeted biologic inhibitor of VEGFR-2 based on a domain of human fibronectin, in recurrent glioblastoma.

    abstract::VEGF signaling through VEGFR-2 is the major factor in glioblastoma angiogenesis. CT-322, a pegylated protein engineered from the 10th type III human fibronectin domain, binds the VEGFR-2 extracellular domain with high specificity and affinity to block VEGF-induced VEGFR-2 signaling. This study evaluated CT-322 in an o...

    journal_title:Investigational new drugs

    pub_type: 杂志文章,随机对照试验

    doi:10.1007/s10637-014-0186-2

    authors: Schiff D,Kesari S,de Groot J,Mikkelsen T,Drappatz J,Coyle T,Fichtel L,Silver B,Walters I,Reardon D

    更新日期:2015-02-01 00:00:00

  • Inhibition of human vascular endothelial cell migration and capillary-like tube formation by the microtubule-stabilizing agent peloruside A.

    abstract::Peloruside A is a microtubule-stabilizing agent that is currently under investigation as a potential anticancer agent. Peloruside A binds to a site on β-tubulin that is distinct to that of the taxanes (paclitaxel and docetaxel) and the epothilones. An attractive clinical quality of microtubule-stabilizing agents is th...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/s10637-015-0232-8

    authors: Chan A,Singh AJ,Northcote PT,Miller JH

    更新日期:2015-06-01 00:00:00

  • Effective upfront treatment with low-dose ibrutinib for a patient with B cell prolymphocytic leukemia.

    abstract::B cell prolymphocytic leukemia (B-PLL) is a rare and aggressive disease that is associated with poor survival. Although initially asymptomatic patients do not require therapy, most patients will progress and inevitably require treatment. More than 50% of patients with B-PLL carry abnormalities in the TP53 tumor suppre...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/s10637-020-00902-9

    authors: Oka S,Ono K,Nohgawa M

    更新日期:2020-10-01 00:00:00

  • Circadian rhythm and seasonal dependence in the toxicological response of mice to epirubicin.

    abstract::Compared to doxorubicin, equimolar epirubicin toxicity is reduced by about 50% by the epimerization of a hydrogen and hydroxyl group at the 4' position of the anthracycline sugar moiety. The circadian timing of doxorubicin administration markedly affects its lethal and sub-lethal bone marrow and gut toxicities in mice...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/BF00173645

    authors: Mormont MC,von Roemeling R,Sothern RB,Berestka JS,Langevin TR,Wick M,Hrushesky WJ

    更新日期:1988-12-01 00:00:00

  • Targeting histone deacetyalses in the treatment of B- and T-cell malignancies.

    abstract::HDAC inhibitors (HDACI) are now emerging as one of the most promising new classes of drugs for the treatment of select forms of non-Hodgkin's lymphoma (NHL). They are particularly active in T-cell lymphomas, possibly hodgkin's lymphoma and indolent B cell lymphomas. Presently, two of these agents, vorinostat and romid...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/s10637-010-9591-3

    authors: Zain J,O'Connor OA

    更新日期:2010-12-01 00:00:00

  • Phase I trial of Adozelesin using the treatment schedule of daily x5 every 3 weeks.

    abstract::CC-1065 is a unique alkylating agent that preferentially binds in the minor groove of double-stranded DNA at adenine-thymine-rich sites. Although it has broad antitumor activity in preclinical models its development was discontinued because of deaths observed during preclinical toxicology studies. Adozelesin is a pote...

    journal_title:Investigational new drugs

    pub_type: 临床试验,杂志文章

    doi:10.1007/BF00873138

    authors: Foster BJ,LoRusso PM,Poplin E,Zalupski M,Valdivieso M,Wozniak A,Flaherty L,Kasunic DA,Earhart RH,Baker LH

    更新日期:1996-01-01 00:00:00

  • The notorious "drug lag" for oncology drugs in Japan.

    abstract::This study aimed to analyze the oncology "drug lag" (i.e., the delay in time required for the approval of oncology drugs) in Japan compared with that in the United States of America (US) or the European Union (EU) and to identify the factors associated with this lag. Using publicly available information, we collected ...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/s10637-011-9638-0

    authors: Yonemori K,Hirakawa A,Ando M,Hirata T,Yunokawa M,Shimizu C,Katsumata N,Tamura K,Fujiwara Y

    更新日期:2011-08-01 00:00:00

  • Anticancer activities of vitamin K3 analogues.

    abstract::In a previous study we reported on the synthesis of 1,4-naphthoquinone-sulfides by thiolation of 1,4-naphthohydroquinones with primary aryl and alkyl thiols using laccase as catalyst. These compounds were synthesized as Vitamin K3 analogues. Vitamin K3 (VK3; 2-methyl-1,4-naphthoquinone; menadione) is known to have pot...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/s10637-019-00855-8

    authors: Wellington KW,Hlatshwayo V,Kolesnikova NI,Saha ST,Kaur M,Motadi LR

    更新日期:2020-04-01 00:00:00

  • A retrospective pooled analysis of trabectedin safety in 1,132 patients with solid tumors treated in phase II clinical trials.

    abstract:PURPOSE:To summarize the safety experience obtained from phase II clinical trials conducted with trabectedin as single-agent therapy in patients with advanced solid tumors. METHODS:This retrospective analysis includes 1,132 patients exposed to trabectedin in 19 phase II trials carried out between February 1999 and Apr...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/s10637-011-9662-0

    authors: Le Cesne A,Yovine A,Blay JY,Delaloge S,Maki RG,Misset JL,Frontelo P,Nieto A,Jiao JJ,Demetri GD

    更新日期:2012-06-01 00:00:00

  • Phase I study of 4-demethoxydaunorubicin.

    abstract::4-demethoxydaunorubicin (4-dm DNR), a new analog of daunorubicin, was tested at an every 3-week dose schedule in 63 evaluable patients with various forms of disseminated malignancy. Utilizing the intravenous (i.v.) route of administration, the maximum tolerated dose (MTD) was 15-18 mg/m2; with the oral route the MTD w...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/BF00172075

    authors: Bonfante V,Ferrari L,Villani F,Bonadonna G

    更新日期:1983-01-01 00:00:00

  • Sequential studies on the role of mitoxantrone in the treatment of acute leukemia.

    abstract::Mitoxantrone (Novantrone; 1, 4-dihydroxy-5, 8-bis [[2-[(2-hydroxyethyl) amino]ethyl]amino-] 9, 10 anthracenedione dihydrochloride (NSC 301739] is a synthetic anthracenedione with intercalating properties. Activity has been shown in preclinical studies in mice bearing intraperitoneal P388 and L1210 leukaemias, ADJ-Pc6 ...

    journal_title:Investigational new drugs

    pub_type: 临床试验,杂志文章

    doi:10.1007/BF00174172

    authors: Prentice HG,Wimperis JZ,Robbins G

    更新日期:1985-01-01 00:00:00

  • T cell cytotoxicity toward hematologic malignancy via B7-H3 targeting.

    abstract::T cells are important effectors in anti-tumor immunity, and aberrant expression of B7 family members may contribute to tumor evasion. In this study, we analyzed expression of costimulatory molecules on human hematologic tumor cells and explored whether B7-H3, a member of the B7 superfamily, is an effective target for ...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/s10637-019-00819-y

    authors: Sun X,Yu Y,Ma L,Xue X,Gao Z,Ma J,Zhang M

    更新日期:2020-06-01 00:00:00

  • Sunitinib inducing tumor lysis syndrome in a patient treated for renal carcinoma.

    abstract::Sunitinib is an oral antityrosine kinase inhibitor that has antiangiogenic and antitumor activities. It has been approved for the treatment of advanced RCC and for imatinib-refractory gastrointestinal stromal tumors (GIST). Tumor lysis syndrom can occur in solid tumors. We report a case of patient with metastatic RCC ...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/s10637-009-9275-z

    authors: Michels J,Lassau N,Gross-Goupil M,Massard C,Mejean A,Escudier B

    更新日期:2010-10-01 00:00:00

  • Contributions from emerging transcriptomics technologies and computational strategies for drug discovery.

    abstract::Drug discovery involves various steps and is a long process being even more demanding for complex diseases such as cancer. Tumors are ensembles of subpopulations with different mutations, require very specific and effective strategies. Conventional drug screening technologies may not be adequate and efficient anymore....

    journal_title:Investigational new drugs

    pub_type: 杂志文章,评审

    doi:10.1007/s10637-014-0081-x

    authors: Kadioglu O,Efferth T

    更新日期:2014-12-01 00:00:00

  • Novel palladium (II) complexes with tetradentate thiosemicarbazones. Synthesis, characterization, in vitro cytotoxicity and xanthine oxidase inhibition.

    abstract::In vitro cytotoxicity and xanthine oxidase inhibition capabilities were investigated for five palladium (II) chelate complexes. The palladium complexes were synthesized by starting from S-alkyl-thiosemicarbazones where the alkyl component is methyl, ethyl, propyl or butyl. The solid complexes are characterized by elem...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/s10637-019-00751-1

    authors: Özerkan D,Ertik O,Kaya B,Kuruca SE,Yanardag R,Ülküseven B

    更新日期:2019-12-01 00:00:00

  • Discovery of oxyepiberberine as a novel tubulin polymerization inhibitor and an anti-colon cancer agent against LS-1034 cells.

    abstract::Coptis chinensis Franch. has been extensively used in traditional Chinese medicine. The chemical structure of oxyepiberberine, as an alkaloid isolated from Coptis chinensis Franch., has been previously studied. However, anti-cancer effects and underlying mechanisms of oxyepiberberine need to be explored. This study ai...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/s10637-020-01006-0

    authors: Ning H,Lu W,Jia Q,Wang J,Yao T,Lv S,Li Y,Wen H

    更新日期:2020-09-30 00:00:00

  • A novel LRRFIP1-ALK fusion in inflammatory myofibroblastic tumor of hip and response to crizotinib.

    abstract::An inflammatory myofibroblastic tumor (IMT) is a rare invasive soft tissue mass with intramuscular penetration that is primarily treated via a surgical procedure. However, with unclear boundaries and a high rate of relapse, there is no standard treatment for recurrence or unresectable tumors. It is noteworthy that app...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/s10637-020-00984-5

    authors: Liu W,Duan Q,Gong L,Yang Y,Huang Z,Guo H,Niu X

    更新日期:2020-09-11 00:00:00

  • Sphingosine-1-phosphate: a potential therapeutic agent against human breast cancer.

    abstract::Sphingosine-1-phosphate (S1P) is an important regulator of cancer development and progression. Its cellular concentration is controlled predominantly by sphingosine kinase (SK) and sphingosine-1-phosphate lyase (SPL). In the current study we showed that mRNA expressions for both SK and SPL were up-regulated throughout...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/s10637-009-9375-9

    authors: Ling B,Chen L,Alcorn J,Ma B,Yang J

    更新日期:2011-04-01 00:00:00

  • Phase I study of oral CP-4126, a gemcitabine derivative, in patients with advanced solid tumors.

    abstract::CP-4126 is a gemcitabine (2',2'-difluorodeoxycytidine; dFdC) 5' elaidic acid ester. The purpose of this dose-escalating study was to assess safety, pharmacokinetics (PK) and preliminary antitumor activity of the oral formulation and to determine the recommended dose (RD) for phase II studies. The study had a two-step ...

    journal_title:Investigational new drugs

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1007/s10637-013-9925-z

    authors: Stuurman FE,Voest EE,Awada A,Witteveen PO,Bergeland T,Hals PA,Rasch W,Schellens JH,Hendlisz A

    更新日期:2013-08-01 00:00:00

  • A first-in-human phase I trial of LY2780301, a dual p70 S6 kinase and Akt Inhibitor, in patients with advanced or metastatic cancer.

    abstract::The primary objective of this phase I study of LY2780301, a dual p70 S6 kinase and Akt inhibitor, was to determine the recommended phase II dose as a single agent in patients with advanced cancer. Secondary objectives included safety, pharmacokinetic, and pharmacodynamic analyses, and co-clinical analyses in Avatar mo...

    journal_title:Investigational new drugs

    pub_type: 杂志文章,多中心研究

    doi:10.1007/s10637-015-0241-7

    authors: Azaro A,Rodon J,Calles A,Braña I,Hidalgo M,Lopez-Casas PP,Munoz M,Westwood P,Miller J,Moser BA,Ohnmacht U,Bumgardner W,Benhadji KA,Calvo E

    更新日期:2015-06-01 00:00:00

  • Effects of the tumor vasculature targeting agent NGR-TNF on the tumor microenvironment in murine lymphomas.

    abstract::TNF-alpha may improve drug delivery to tumors by alteration of vascular permeability. However, toxicity precludes its systemic administration in patients. NGR-TNF comprises TNF coupled to the peptide CNGRC, which is a ligand for CD13. CD13 is expressed on tumor vasculature. Therefore, to assess the efficacy of NGR-TNF...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/s10637-005-4540-2

    authors: van Laarhoven HW,Gambarota G,Heerschap A,Lok J,Verhagen I,Corti A,Toma S,Gallo Stampino C,van der Kogel A,Punt CJ

    更新日期:2006-01-01 00:00:00

  • Gemcitabine and radiosensitization in human tumor cells.

    abstract::Gemcitabine is a nucleoside analogue with excellent clinical activity against solid tumors. Within the cell, gemcitabine is rapidly phosphorylated to its active di- and triphosphate metabolites. Cytotoxicity with gemcitabine appears to be related to multiple effects on DNA replication, where gemcitabine triphosphate c...

    journal_title:Investigational new drugs

    pub_type: 杂志文章,评审

    doi:10.1007/BF00194528

    authors: Shewach DS,Lawrence TS

    更新日期:1996-01-01 00:00:00

  • First-in-human study of the antibody DR5 agonist DS-8273a in patients with advanced solid tumors.

    abstract::Background DR5 is a transmembrane receptor that transduces extracellular ligand-binding to activate apoptosis signaling cascades. This phase 1 study evaluated the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of a new monoclonal antibody potent DR5 agonist, DS-8273a, in subjects with advanced solid...

    journal_title:Investigational new drugs

    pub_type: 杂志文章,多中心研究

    doi:10.1007/s10637-016-0420-1

    authors: Forero A,Bendell JC,Kumar P,Janisch L,Rosen M,Wang Q,Copigneaux C,Desai M,Senaldi G,Maitland ML

    更新日期:2017-06-01 00:00:00