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Volumn 31, Issue 5, 2013, Pages 1236-1243

Phase i clinical and pharmacokinetic study of trabectedin and cisplatin given every three weeks in patients with advanced solid tumors

Author keywords

Antitumor; Cisplatin; Cytotoxic; Dose limiting toxicities; Phase I; Trabectedin

Indexed keywords

CISPLATIN; TRABECTEDIN;

EID: 84884818867     PISSN: 01676997     EISSN: 15730646     Source Type: Journal    
DOI: 10.1007/s10637-013-9942-y     Document Type: Article
Times cited : (16)

References (35)
  • 2
    • 0035146702 scopus 로고    scopus 로고
    • Ecteinascidin-743 (ET-743), a natural marine compound, with a unique mechanism of action
    • 11165136 10.1016/S0959-8049(00)00357-9 1:CAS:528:DC%2BD3MXntlOntQ%3D%3D
    • Erba E, Bergamaschi D, Bassano L, Damia G, Ronzoni S, Faircloth GT, D'Incalci M (2001) Ecteinascidin-743 (ET-743), a natural marine compound, with a unique mechanism of action. Eur J Cancer 37:97-105
    • (2001) Eur J Cancer , vol.37 , pp. 97-105
    • Erba, E.1    Bergamaschi, D.2    Bassano, L.3    Damia, G.4    Ronzoni, S.5    Faircloth, G.T.6    D'Incalci, M.7
  • 8
    • 71049192700 scopus 로고    scopus 로고
    • Phase II randomized study of trabectedin given as two different every 3 weeks dose schedules (1.5 mg/m2 24 h or 1.3 mg/m2 3 h) to patients with relapsed, platinum-sensitive, advanced ovarian cancer
    • 19556318 10.1093/annonc/mdp198
    • Del Campo JM, Roszak A, Bidzinski M, Ciuleanu TE, Hogberg T, Wojtukiewicz MZ, Poveda A, Boman K, Westermann AM, Lebedinsky C (2009) Phase II randomized study of trabectedin given as two different every 3 weeks dose schedules (1.5 mg/m2 24 h or 1.3 mg/m2 3 h) to patients with relapsed, platinum-sensitive, advanced ovarian cancer. Ann Oncol 20:1794-1802
    • (2009) Ann Oncol , vol.20 , pp. 1794-1802
    • Del Campo, J.M.1    Roszak, A.2    Bidzinski, M.3    Ciuleanu, T.E.4    Hogberg, T.5    Wojtukiewicz, M.Z.6    Poveda, A.7    Boman, K.8    Westermann, A.M.9    Lebedinsky, C.10
  • 9
    • 37049038819 scopus 로고    scopus 로고
    • A phase II study of trabectedin single agent in patients with recurrent ovarian cancer previously treated with platinum-based regimens
    • 18000504 10.1038/sj.bjc.6604088 1:CAS:528:DC%2BD2sXhsVSrsL3N
    • Krasner CN, McMeekin DS, Chan S, Braly PS, Renshaw FG, Kaye S, Provencher DM, Campos S, Gore ME (2007) A phase II study of trabectedin single agent in patients with recurrent ovarian cancer previously treated with platinum-based regimens. Br J Cancer 97:1618-1624
    • (2007) Br J Cancer , vol.97 , pp. 1618-1624
    • Krasner, C.N.1    McMeekin, D.S.2    Chan, S.3    Braly, P.S.4    Renshaw, F.G.5    Kaye, S.6    Provencher, D.M.7    Campos, S.8    Gore, M.E.9
  • 11
    • 83455183825 scopus 로고    scopus 로고
    • Final survival results of the randomized phase III study of trabectedin with pegylated liposomal doxorubicin (PLD) versus PLD in recurrent ovarian cancer
    • abstr 5046
    • Monk BJ, Herzog TJ, Kaye SB, Krasner CN, Vermorken JB, Muggia F, Pujade-Lourraine E, Zintl P, Parekh TV, Poveda A (2011) Final survival results of the randomized phase III study of trabectedin with pegylated liposomal doxorubicin (PLD) versus PLD in recurrent ovarian cancer. J Clin Oncol 29:suppl15s; abstr 5046
    • (2011) J Clin Oncol , vol.29 , Issue.SUPPL. 15
    • Monk, B.J.1    Herzog, T.J.2    Kaye, S.B.3    Krasner, C.N.4    Vermorken, J.B.5    Muggia, F.6    Pujade-Lourraine, E.7    Zintl, P.8    Parekh, T.V.9    Poveda, A.10
  • 12
    • 0029838307 scopus 로고    scopus 로고
    • DNA sequence- and structure-selective alkylation of guanine N2 in the DNA minor groove by ecteinascidin 743, a potent antitumor compound from the Caribbean tunicate Ecteinascidia turbinata
    • 8873596 10.1021/bi960306b 1:CAS:528:DyaK28XlvVSls7k%3D
    • Pommier Y, Kohlhagen G, Bailly C, Waring M, Mazumder A, Kohn KW (1996) DNA sequence- and structure-selective alkylation of guanine N2 in the DNA minor groove by ecteinascidin 743, a potent antitumor compound from the Caribbean tunicate Ecteinascidia turbinata. Biochemistry 35:13303-13309
    • (1996) Biochemistry , vol.35 , pp. 13303-13309
    • Pommier, Y.1    Kohlhagen, G.2    Bailly, C.3    Waring, M.4    Mazumder, A.5    Kohn, K.W.6
  • 13
    • 0033566150 scopus 로고    scopus 로고
    • Ecteinascidin 743: A minor groove alkylator that bends DNA toward the major groove
    • 10411470 10.1021/jm990241l 1:CAS:528:DyaK1MXjvFGiu7k%3D
    • Zewail-Foote M, Hurley LH (1999) Ecteinascidin 743: a minor groove alkylator that bends DNA toward the major groove. J Med Chem 42:2493-2497
    • (1999) J Med Chem , vol.42 , pp. 2493-2497
    • Zewail-Foote, M.1    Hurley, L.H.2
  • 14
    • 0242527216 scopus 로고    scopus 로고
    • Interaction of anticancer drug cisplatin with guanine: Density functional theory and surface-enhanced Raman spectroscopy study
    • 14587070 10.1002/bip.10480 1:CAS:528:DC%2BD3sXptFWlt7s%3D
    • Giese B, McNaughton D (2003) Interaction of anticancer drug cisplatin with guanine: density functional theory and surface-enhanced Raman spectroscopy study. Biopolymers 72:472-489
    • (2003) Biopolymers , vol.72 , pp. 472-489
    • Giese, B.1    McNaughton, D.2
  • 15
    • 77955505177 scopus 로고    scopus 로고
    • A review of trabectedin (ET-743): A unique mechanism of action
    • 20647340 10.1158/1535-7163.MCT-10-0263
    • D'Incalci M, Galmarini CM (2010) A review of trabectedin (ET-743): a unique mechanism of action. Mol Cancer Ther 9:2157-2163
    • (2010) Mol Cancer Ther , vol.9 , pp. 2157-2163
    • D'Incalci, M.1    Galmarini, C.M.2
  • 16
    • 0035874074 scopus 로고    scopus 로고
    • Unique pattern of ET-743 activity in different cellular systems with defined deficiencies in DNA-repair pathways
    • 11304695 10.1002/ijc.1221 1:CAS:528:DC%2BD3MXjs1eitL4%3D
    • Damia G, Silvestri S, Carrassa L, Filiberti L, Faircloth GT, Liberi G, Foiani M, D'Incalci M (2001) Unique pattern of ET-743 activity in different cellular systems with defined deficiencies in DNA-repair pathways. Int J Cancer 92:583-588
    • (2001) Int J Cancer , vol.92 , pp. 583-588
    • Damia, G.1    Silvestri, S.2    Carrassa, L.3    Filiberti, L.4    Faircloth, G.T.5    Liberi, G.6    Foiani, M.7    D'Incalci, M.8
  • 20
    • 77951738158 scopus 로고    scopus 로고
    • Phase i and pharmacokinetic study of sequential paclitaxel and trabectedin every 2 weeks in patients with advanced solid tumors
    • 20406837 10.1158/1078-0432.CCR-10-0062 1:CAS:528:DC%2BC3cXltlegt7k%3D
    • Chu Q, Mita A, Forouzesh B, Tolcher AW, Schwartz G, Nieto A, Soto-Matos A, Alfaro V, Lebedinsky C, Rowinsky EK (2010) Phase I and pharmacokinetic study of sequential paclitaxel and trabectedin every 2 weeks in patients with advanced solid tumors. Clin Cancer Res 16:2656-2665
    • (2010) Clin Cancer Res , vol.16 , pp. 2656-2665
    • Chu, Q.1    Mita, A.2    Forouzesh, B.3    Tolcher, A.W.4    Schwartz, G.5    Nieto, A.6    Soto-Matos, A.7    Alfaro, V.8    Lebedinsky, C.9    Rowinsky, E.K.10
  • 21
    • 0042413836 scopus 로고    scopus 로고
    • Randomized, multinational, phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for advanced non-small-cell lung cancer: The TAX 326 study group
    • 12837811 10.1200/JCO.2003.12.046 1:CAS:528:DC%2BD2cXpsVWqt7c%3D
    • Fossella F, Pereira JR, von Pawel J, Pluzanska A, Gorbounova V, Kaukel E, Mattson KV, Ramlau R, Szczesna A, Fidias P, Millward M, Belani CP (2003) Randomized, multinational, phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for advanced non-small-cell lung cancer: the TAX 326 study group. J Clin Oncol 21:3016-3024
    • (2003) J Clin Oncol , vol.21 , pp. 3016-3024
    • Fossella, F.1    Pereira, J.R.2    Von Pawel, J.3    Pluzanska, A.4    Gorbounova, V.5    Kaukel, E.6    Mattson, K.V.7    Ramlau, R.8    Szczesna, A.9    Fidias, P.10    Millward, M.11    Belani, C.P.12
  • 22
    • 35348827299 scopus 로고    scopus 로고
    • Phase III randomized trial of intravenous cisplatin plus a 24- or 96-hour infusion of paclitaxel in epithelial ovarian cancer: A Gynecologic Oncology Group Study
    • 17906207 10.1200/JCO.2006.10.3846 1:CAS:528:DC%2BD2sXht1ertrjL
    • Spriggs DR, Brady MF, Vaccarello L, Clarke-Pearson DL, Burger RA, Mannel R, Boggess JF, Lee RB, Hanly M (2007) Phase III randomized trial of intravenous cisplatin plus a 24- or 96-hour infusion of paclitaxel in epithelial ovarian cancer: a Gynecologic Oncology Group Study. J Clin Oncol 25:4466-4471
    • (2007) J Clin Oncol , vol.25 , pp. 4466-4471
    • Spriggs, D.R.1    Brady, M.F.2    Vaccarello, L.3    Clarke-Pearson, D.L.4    Burger, R.A.5    Mannel, R.6    Boggess, J.F.7    Lee, R.B.8    Hanly, M.9
  • 23
    • 0141688377 scopus 로고    scopus 로고
    • Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: A Gynecologic Oncology Group study
    • 12860964 10.1200/JCO.2003.02.153 1:CAS:528:DC%2BD2cXps1aktbk%3D
    • Ozols RF, Bundy BN, Greer BE, Fowler JM, Clarke-Pearson D, Burger RA, Mannel RS, DeGeest K, Hartenbach EM, Baergen R (2003) Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: a Gynecologic Oncology Group study. J Clin Oncol 21:3194-3200
    • (2003) J Clin Oncol , vol.21 , pp. 3194-3200
    • Ozols, R.F.1    Bundy, B.N.2    Greer, B.E.3    Fowler, J.M.4    Clarke-Pearson, D.5    Burger, R.A.6    Mannel, R.S.7    Degeest, K.8    Hartenbach, E.M.9    Baergen, R.10
  • 24
    • 34447338601 scopus 로고    scopus 로고
    • Phase III study in stage IV non-small-cell lung cancer patients treated with two courses of cisplatin/gemcitabine followed by a randomization to three additional courses of the same combination or gemcitabine alone
    • 17351253 10.1093/annonc/mdm061 1:STN:280:DC%2BD2s3ns1yhtQ%3D%3D
    • Novello S, Bruzzi P, Barone C, Buosi R, Masotti A, Michetti G, Fioretti M, Barbera S, Spatafora M, Garetto L, Mazzanti P, Dongiovanni V, Selvaggi G, Crino L, Scagliotti GV (2007) Phase III study in stage IV non-small-cell lung cancer patients treated with two courses of cisplatin/gemcitabine followed by a randomization to three additional courses of the same combination or gemcitabine alone. Ann Oncol 18:903-908
    • (2007) Ann Oncol , vol.18 , pp. 903-908
    • Novello, S.1    Bruzzi, P.2    Barone, C.3    Buosi, R.4    Masotti, A.5    Michetti, G.6    Fioretti, M.7    Barbera, S.8    Spatafora, M.9    Garetto, L.10    Mazzanti, P.11    Dongiovanni, V.12    Selvaggi, G.13    Crino, L.14    Scagliotti, G.V.15
  • 25
    • 33847756722 scopus 로고    scopus 로고
    • A phase III randomized study comparing paclitaxel and cisplatin versus cyclophosphamide and cisplatin in patients with advanced ovarian cancer
    • 17348460 1:CAS:528:DC%2BD2sXjs12ms7c%3D
    • Mouratidou D, Gennatas C, Michalaki V, Papadimitriou A, Andreadis CH, Sykiotis C, Tsavaris N (2007) A phase III randomized study comparing paclitaxel and cisplatin versus cyclophosphamide and cisplatin in patients with advanced ovarian cancer. Anticancer Res 27:681-685
    • (2007) Anticancer Res , vol.27 , pp. 681-685
    • Mouratidou, D.1    Gennatas, C.2    Michalaki, V.3    Papadimitriou, A.4    Andreadis, C.H.5    Sykiotis, C.6    Tsavaris, N.7
  • 27
    • 0034594628 scopus 로고    scopus 로고
    • New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada
    • 10655437 10.1093/jnci/92.3.205 1:STN:280:DC%2BD3c7it1Gitg%3D%3D
    • Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG (2000) New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 92:205-216
    • (2000) J Natl Cancer Inst , vol.92 , pp. 205-216
    • Therasse, P.1    Arbuck, S.G.2    Eisenhauer, E.A.3    Wanders, J.4    Kaplan, R.S.5    Rubinstein, L.6    Verweij, J.7    Van Glabbeke, M.8    Van Oosterom, A.T.9    Christian, M.C.10    Gwyther, S.G.11
  • 28
    • 7844247581 scopus 로고    scopus 로고
    • Quantitative determination of Ecteinascidin 743 in human plasma by miniaturized high-performance liquid chromatography coupled with electrospray ionization tandem mass spectrometry
    • 9835068 10.1002/(SICI)1096-9888(1998110)33:11<1134: AID-JMS730>3.0.CO;2-S 1:CAS:528:DyaK1cXns1Gntbw%3D
    • Rosing H, Hillebrand MJ, Jimeno JM, Gomez A, Floriano P, Faircloth G, Henrar RE, Vermorken JB, Cvitkovic E, Bult A, Beijnen JH (1998) Quantitative determination of Ecteinascidin 743 in human plasma by miniaturized high-performance liquid chromatography coupled with electrospray ionization tandem mass spectrometry. J Mass Spectrom 33:1134-1140
    • (1998) J Mass Spectrom , vol.33 , pp. 1134-1140
    • Rosing, H.1    Hillebrand, M.J.2    Jimeno, J.M.3    Gomez, A.4    Floriano, P.5    Faircloth, G.6    Henrar, R.E.7    Vermorken, J.B.8    Cvitkovic, E.9    Bult, A.10    Beijnen, J.H.11
  • 29
    • 1942516814 scopus 로고    scopus 로고
    • Simple and sensitive liquid chromatographic quantitative analysis of the novel marine anticancer drug Yondelis (ET-743, trabectedin) in human plasma using column switching and tandem mass spectrometric detection
    • 15103657 10.1002/jms.608 1:CAS:528:DC%2BD2cXjtlKrur0%3D
    • Stokvis E, Rosing H, Lopez-Lazaro L, Beijnen JH (2004) Simple and sensitive liquid chromatographic quantitative analysis of the novel marine anticancer drug Yondelis (ET-743, trabectedin) in human plasma using column switching and tandem mass spectrometric detection. J Mass Spectrom 39:431-436
    • (2004) J Mass Spectrom , vol.39 , pp. 431-436
    • Stokvis, E.1    Rosing, H.2    Lopez-Lazaro, L.3    Beijnen, J.H.4
  • 30
    • 33748988195 scopus 로고    scopus 로고
    • Sensitive inductively coupled plasma mass spectrometry assay for the determination of platinum originating from cisplatin, carboplatin, and oxaliplatin in human plasma ultrafiltrate
    • 16929560 10.1002/jms.1087 1:CAS:528:DC%2BD28XhtVCks7zE
    • Brouwers EE, Tibben MM, Rosing H, Hillebrand MJ, Joerger M, Schellens JH, Beijnen JH (2006) Sensitive inductively coupled plasma mass spectrometry assay for the determination of platinum originating from cisplatin, carboplatin, and oxaliplatin in human plasma ultrafiltrate. J Mass Spectrom 41:1186-1194
    • (2006) J Mass Spectrom , vol.41 , pp. 1186-1194
    • Brouwers, E.E.1    Tibben, M.M.2    Rosing, H.3    Hillebrand, M.J.4    Joerger, M.5    Schellens, J.H.6    Beijnen, J.H.7
  • 31
    • 11244308198 scopus 로고    scopus 로고
    • Pharmacokinetics of platinum after oral or intravenous cisplatin: A phase 1 study in 32 adult patients
    • 15258698 10.1007/s00280-004-0852-8 1:CAS:528:DC%2BD2cXhtVWjt77N
    • Urien S, Brain E, Bugat R, Pivot X, Lochon I, Van ML, Vauzelle F, Lokiec F (2005) Pharmacokinetics of platinum after oral or intravenous cisplatin: a phase 1 study in 32 adult patients. Cancer Chemother Pharmacol 55:55-60
    • (2005) Cancer Chemother Pharmacol , vol.55 , pp. 55-60
    • Urien, S.1    Brain, E.2    Bugat, R.3    Pivot, X.4    Lochon, I.5    Van, M.L.6    Vauzelle, F.7    Lokiec, F.8
  • 34
    • 84864348875 scopus 로고    scopus 로고
    • A retrospective pooled analysis of trabectedin safety in 1,132 patients with solid tumors treated in phase II clinical trials
    • 21484250 10.1007/s10637-011-9662-0 1:CAS:528:DC%2BC38XmvFalsr0%3D
    • Le Cesne A, Yovine A, Blay JY, Delaloge S, Maki RG, Misset JL, Frontelo P, Nieto A, Jiao JJ, Demetri GD (2012) A retrospective pooled analysis of trabectedin safety in 1,132 patients with solid tumors treated in phase II clinical trials. Invest New Drugs 30:1193-1202
    • (2012) Invest New Drugs , vol.30 , pp. 1193-1202
    • Le Cesne, A.1    Yovine, A.2    Blay, J.Y.3    Delaloge, S.4    Maki, R.G.5    Misset, J.L.6    Frontelo, P.7    Nieto, A.8    Jiao, J.J.9    Demetri, G.D.10
  • 35
    • 2942520949 scopus 로고    scopus 로고
    • Population pharmacokinetics of total and unbound plasma cisplatin in adult patients
    • 15151521 10.1111/j.1365-2125.2004.02082.x 1:CAS:528:DC%2BD2cXls1SisLo%3D
    • Urien S, Lokiec F (2004) Population pharmacokinetics of total and unbound plasma cisplatin in adult patients. Br J Clin Pharmacol 57:756-763
    • (2004) Br J Clin Pharmacol , vol.57 , pp. 756-763
    • Urien, S.1    Lokiec, F.2


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