Trabectedin (Yondelis™, formerly ET-743), a mass balance study in patients with advanced cancer

Investigational New Drugs

Volumn 23, Issue 5, 2005, Pages 429-436

  Beumer, J H ^a,e   Rademaker Lakhai, J M ^b   Rosing, H ^a   Lopez Lazaro, L ^c   Beijnen, J H ^a,d   Schellens, J H M ^b,d  

^a SLOTERVAART HOSPITAL   (Netherlands)

^b ANTONI VAN LEEUWENHOEK HOSPITAL   (Netherlands)

^c PHARMAMAR S A   (Spain)

^d UTRECHT UNIVERSITY   (Netherlands)

^e UNIVERSITY OF PITTSBURGH CANCER INSTITUTE   (United States)

Author keywords

Disposition; ET 743; Human; Mass balance; Trabectedin

Indexed keywords

CARBON 14; TRABECTEDIN; 1,3 DIOXOLANE DERIVATIVE; ALKYLATING AGENT; CARBON; ISOQUINOLINE DERIVATIVE; TETRAHYDROISOQUINOLINE DERIVATIVE;

ADULT; ADVANCED CANCER; AGED; ARTICLE; BLOOD SAMPLING; CLINICAL ARTICLE; COMPARATIVE STUDY; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG ELIMINATION; DRUG METABOLISM; FECES ANALYSIS; FEMALE; HUMAN; ISOTOPE LABELING; MALE; PRIORITY JOURNAL; RADIOACTIVITY; URINALYSIS; URINARY EXCRETION; AREA UNDER THE CURVE; BLOOD; CHEMISTRY; CLINICAL TRIAL; CONNECTIVE TISSUE TUMOR; FECES; HALF LIFE TIME; KIDNEY TUMOR; LUNG NON SMALL CELL CANCER; LUNG TUMOR; MIDDLE AGED; PHASE 2 CLINICAL TRIAL; SARCOMA; URINE;

ADULT; AGED; ANTINEOPLASTIC AGENTS, ALKYLATING; AREA UNDER CURVE; CARBON RADIOISOTOPES; CARCINOMA, NON-SMALL-CELL LUNG; DIOXOLES; FECES; FEMALE; HALF-LIFE; HUMANS; ISOQUINOLINES; KIDNEY NEOPLASMS; LUNG NEOPLASMS; MALE; MIDDLE AGED; SARCOMA; SARCOMA, SYNOVIAL; TETRAHYDROISOQUINOLINES;

EID: 23844542907     PISSN: 01676997     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10637-005-2902-4     Document Type: Article

References (25)

1. Blay JY, Le Cesne A, Verweij J, Scurr M, Seynaeve C, Bonvalot S, Hogendoorn P, Jimeno J, Evrard V, Van Glabbeke M, Judson I: A phase II study of ET-743/trabectedin ('Yondelis') for patients with advanced gastrointestinal stromal tumours. Eur J Cancer 40: 1327-1331, 2004
2. Casanova M, Casali PG, Sessa C, et al.: Phase II study of 3-hour infusion of ET-743 in pretreated adult and pediatric patients with advanced/recurrent sarcomas-preliminary results from the Sendo and Italian Sarcoma Group (Abstract). Med Pediatr Oncol 39: 257, 2002
3. Dileo P, Casali PG, Bacci G, et al.: Phase II evaluation of 3-hr infusion ET-743 in patients with recurrent sarcomas (Abstract). Proc Am Soc Clin Oncol 21: 408a, 2002
4. Garcia-Carbonero R, Supko JG, Manola J, Seiden MV, Harmon D, Ryan DP, Quigley MT, Merriam P, Canniff J, Goss G, Matulonis U, Maki RG, Lopez T, Puchalski TA, Sancho MA, Gomez J, Guzman C, Jimeno J, Demetri GD: Phase II and pharmacokinetic study of ecteinascidin 743 in patients with progressive sarcomas of soft tissues refractory to chemotherapy. J Clin Oncol 22: 1480-1490, 2004
5. George S, Maki RG, Harmon D, Supko J, Morgan J, Seiden M, Buonanno M, Griffin J, Moutsiolis A, Lopez T, Guzman C, Jimeno J, Demetri GD: Phase II study of ecteinascidin-743 (ET-743) given by 3-hour IV infusion in patients (pts) with soft tissue sarcomas (STS) failing prior chemotherapies (Abstract). Proc Am Soc Clin Oncol 21: 408a, 2002
6. Laverdiere C, Kolb EA, Supko JG, Gorlick R, Meyers PA, Maki RG, Wexler L, Demetri GD, Healey JH, Huvos AG, Goorin AM, Bagatell R, Ruiz-Casado A, Guzman C, Jimeno J, Harmon D: Phase II study of ecteinascidin 743 in heavily pretreated patients with recurrent osteosarcoma. Cancer 98: 832-840, 2003
7. Laverdiere C, Kolb A, Meyers P, Gorlick R, Maki RG, Wexler L, Demetri GD, Goorin A, Harmon D, Jimeno J, Guzman C, Bagatell R: Phase II study of ET-743 in recurrent osteosarcoma (Abstract). Proc Am Soc Clin Oncol 21: 96a, 2002
8. Le Cesne A: Phase II study of ET-743 in advanced soft tissue sarcoma (ASTS) in adult: a STBSG-EORTC trial (Abstract). Proc Am Soc Clin Oncol 19: 554a, 2000
9. Ryan DP, Puchalski T, Supko JG, Harmon D, Maki R, Garcia-Carbonero R, Kuhlman C, Winkelman J, Merriam P, Quigley T, Jimeno J, Manola J, Demetri GD: A phase II and pharmacokinetic study of ecteinascidin 743 in patients with gastrointestinal stromal tumors. Oncologist 7: 531-538, 2002
10. Sessa C, Colombo N, Bauer J, Perotti A, Curigliano G, Noberasco C, Capri G, Jimeno J, Marsoni S, Gianni L: Phase II study of salvage ET-743 given as 3-hr infusion in ovarian cancer (oc) patients (Abstract). Ann Oncol 13: 109, 2002
11. Moore BM, Seaman FC, Wheelhouse RT, Hurley LH: Mechanism for the catalytic activation of ecteinscidin 743 and its subsequent alkylation of guanine N2. J Am Chem Soc 120: 2490-2491, 1998
12. Pommier Y, Kohlhagen G, Bailly C, Waring M, Mazumder A, Kohn KW: 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
13. Kanzaki A, Takebayashi Y, Ren XQ, Miyashita H, Mori S, Akiyama S, Pommier Y: Overcoming multidrug drug resistance in P-glycoprotein/MDR1-overexpressing cell lines by ecteinascidin 743. Mol Cancer Ther 1: 1327-1334, 2002
14. Minuzzo M, Marchini S, Broggini M, Faircloth G, D'Incalci M, Mantovani R: Interference of transcriptional activation by the antineoplastic drug ecteinascidin-743. Proc Natl Acad Sci USA 97: 6780-6784, 2000
15. Jin S, Gorfajn B, Faircloth G, Scotto KW: Ecteinascidin 743, a transcription-targeted chemotherapeutic that inhibits MDR1 activation. Proc Natl Acad Sci USA 97: 6775-6779, 2000
16. D'Incalci M, Jimeno J: Reclinical and clinical results with the natural marine product ET-743. Expert Opin Investig Drugs 12: 1843-1853, 2003
17. van Kesteren C, de Vooght MM, Lopez-Lazaro L, Mathot RA, Schellens JHM, Jimeno JM, Beijnen JH: Yondelis (trabectedin, ET-743): The development of an anticancer agent of marine origin. Anticancer Drugs 14: 487-502, 2003
18. Villalona-Calero MA, Eckhardt SG, Weiss G, Hidalgo M, Beijnen JH, van Kesteren C, Rosing H, Campbell E, Kraynak M, Lopez-Lazaro L, Guzman C, Von Hoff DD, Jimeno J, Rowinsky EK: A phase I and pharmacokinetic study of ecteinascidin-743 on a daily x 5 schedule in patients with solid malignancies. Clin Cancer Res 8: 75-85, 2002
19. Sparidans RW, Rosing H, Hillebrand MJ, Lopez-Lazaro L, Jimeno JM, Manzanares I, van Kesteren C, Cvitkovic E, van Oosterom AT, Schellens JHM, Beijnen JH: Search for metabolites of ecteinascidin 743, a novel, marine-derived, anti-cancer agent, in man. Anticancer Drugs 12: 653-666, 2001
20. European Pharmacopoeia. Council of Europe, Strasbourg, 1997
21. Rosing H, Hillebrand MJ, Jimeno JM, Gomez A, Floriano P, Faircloth G, Henrar RE, Vermorken JB, Cvitkovic E, Bult A, Beijnen JH: 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
22. Rowland M, Tozer TN: Clinical pharmacokinetics - concepts and applications. Williams & Wilkins, 1995
23. Schwartz DE, Bollag W, Obrecht P: Distribution and excretion studies of procarbazine in animals and man. Arzneimittelforschung 17: 1389-1393, 1967
24. DeVita VT, Denham C, Davidson JD, Oliverio VT: The physiological disposition of the carcinostatic 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU) in man and animals. Clin Pharmacol Ther 8: 566-577, 1967
25. Chaudhuri NK, Montag BJ, Heidelberger C: Studies on fluorinated pyrimidines. III. The metabolism of 5-fluorouracil-2-C14 and 5-fluoroorotic-2-C14 acid in vivo. Cancer Res 18: 318-328, 1958