Phase I study of TZT-1027, a novel synthetic dolastatin 10 derivative and inhibitor of tubulin polymerization, which was administered to patients with advanced solid tumors on days 1 and 8 in 3-week courses

Cancer Chemotherapy and Pharmacology

Volumn 60, Issue 2, 2007, Pages 285-293

  Tamura, Kenji ^a,d   Nakagawa, Kazuhiko ^a   Kurata, Takayasu ^a   Satoh, Taroh ^a   Nogami, Toshiji ^a   Takeda, Koji ^b   Mitsuoka, Shigeki ^c   Yoshimura, Naruo ^c   Kudoh, Shinzoh ^c   Negoro, Shunichi ^b   Fukuoka, Masahiro ^a  

^a KINKI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^b OSAKA CITY GENERAL HOSPITAL   (Japan)

^c OSAKA CITY UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^d KINDAI UNIVERSITY NARA HOSPITAL   (Japan)

Author keywords

Antitubulin; Dolastatin; Phase I; Solid tumors; TZT 1027

Indexed keywords

ANTIINFECTIVE AGENT; AURISTATIN PE; CARBOPLATIN; CISPLATIN; DOCETAXEL; GRANULOCYTE COLONY STIMULATING FACTOR; PACLITAXEL; SOBLIDOTIN; SODIUM CHLORIDE; TUBULIN; UNCLASSIFIED DRUG;

ADULT; ADVANCED CANCER; AGED; ANOREXIA; ANTINEOPLASTIC ACTIVITY; ARTHRALGIA; ARTICLE; CANCER PATIENT; CLINICAL ARTICLE; CLINICAL TRIAL; CONSTIPATION; DRUG DOSE ESCALATION; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG TOLERABILITY; DRUG WITHDRAWAL; ESOPHAGUS CANCER; EUROPEAN AMERICAN; FEBRILE NEUTROPENIA; FEMALE; HEART VENTRICLE ARRHYTHMIA; HEMATURIA; HUMAN; HYPERTENSION; HYPONATREMIA; INFECTION; INJECTION SITE REACTION; JAPAN; LOW DRUG DOSE; LUNG NON SMALL CELL CANCER; MALAISE; MALE; MAXIMUM TOLERATED DOSE; METASTASIS; MICROTUBULE ASSEMBLY; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEURILEMOMA; NEUROPATHY; NEUTROPENIA; PAIN; PERIPHERAL NEUROPATHY; PHASE 1 CLINICAL TRIAL; PHLEBITIS; PIGMENT DISORDER; PNEUMONIA; PRIORITY JOURNAL; PROTEIN POLYMERIZATION; QT PROLONGATION; RECOMMENDED DRUG DOSE; RECTUM TUMOR; SOLID TUMOR; STOMACH TUMOR; THYMOMA; TREATMENT DURATION; TREATMENT FAILURE; VASCULAR DISEASE; VOMITING;

AGED; ANTINEOPLASTIC AGENTS; AREA UNDER CURVE; DEPSIPEPTIDES; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HALF-LIFE; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASMS; OLIGOPEPTIDES; TREATMENT OUTCOME; TUBULIN; TUBULIN MODULATORS;

EID: 34248374465     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00280-006-0382-7     Document Type: Article

References (20)

1. Cunningham C, Appleman LJ, Kirvan-Visovatti M, Ryan DP, Regan E, Vukelja S, Bonate PL, Ruvuna F, Fram RJ, Jekunen A, Weitman S, Hammond LA, Eder JP Jr (2005) Phase I and pharmacokinetic study of the dolastatin-15 analogue tasidotin (ILX651) administered intravenously on days 1, 3, and 5 every 3 weeks in patients with advanced solid tumors. Clin Cancer Res 11:7825-7833
2. de Jonge MJ, van der Gaast A, Planting AS, van Doorn L, Lems A, Boot I, Wanders J, Satomi M, Verweij J (2005) Phase I and pharmacokinetic study of the dolastatin 10 analogue TZT-1027, given on days 1 and 8 of a 3-week cycle in patients with advanced solid tumors. Clin Cancer Res 11:3806-3813
3. Ebbinghaus S, Rubin E, Hersh E, Cranmer LD, Bonate PL, Fram RJ, Jekunen A, Weitman S, Hammond LA (2005) A phase I study of the dolastatin-15 analogue tasidotin (ILX651) administered intravenously daily for 5 consecutive days every 3 weeks in patients with advanced solid tumors. Clin Cancer Res 11:7807-7816
4. Fujita F, Koike M, Fujita M, Sakamoto Y, Tsukagoshi S (2000) Antitumor effects of TZT-1027, a novel dolastatin 10 derivative, on human tumor xenografts in nude mice. Jpn J Cancer Chemother 27:451-458
5. Hashiguchi N, Kubota T, Koh J, Yamada Y, Saikawa Y, Otani Y, Watanabe M, Kumai K, Kitajima M, Watanabe J, Kobayashi M (2004) TZT-1027 elucidates antitumor activity through direct cytotoxicity and selective blockage of blood supply. Anticancer Res 24:2201-2208
6. Horti J, Juhasz E, Bodrogi I, Ikeda S (2003) A phase I trial of TZT-1027, an inhibitor of tubulin polymerization, in patients with advanced non-small cell lung cancer (NSCLC). AACR-NCI-EORTC Abstr 256
7. Kobayashi M, Natsume T, Tamaoki S, Watanabe J, Asano H, Mikami T, Miyasaka K, Miyazaki K, Gondo M, Sakakibara K, Tsukagoshi S (1997) Antitumor activity of TZT-1027, a novel dolastatin 10 derivative. Jpn J Cancer Res 88:316-327
8. Madden T, Tran HT, Beck D, Huie R, Newman RA, Pusztai L, Wright JJ, Abbruzzese JL (2000) Novel marine-derived anticancer agents: a phase I clinical, pharmacological, and pharmacodynamic study of dolastatin 10 (NSC 376128) in patients with advanced solid tumors. Clin Cancer Res 6:1293-1301
9. Miyazaki K, Kobayashi M, Natsume, Gondo M, Mikami T, Sakakibara K, Tsukagoshi S (1995) Synthesis and antitumor activity of novel dolastatin 10 analogs. Chem Pharm Bull 43:1706-1718
10. Mross K, Herbst K, Berdel WE, Korfel A, von Broen IM, Bankmann Y, Hossfeld DK (1996) Phase I clinical and pharmacokinetic study of LU103793 (Cemadotin hydrochloride) as an intravenous bolus injection in patients with metastatic solid tumors. Onkologie 19:490-495
11. Natsume T, Watanabe J, Koh Y, Fujio N, Ohe Y, Horiuti T, Saijo N, Nishio K, Kobayashi M (2003) Antitumor activity of TZT-1027 (soblidotin) against endothelial growth factor-secreting human lung cancer in vivo. Cancer Sci 94:826-833
12. Natsume T, Watanabe J, Tamaoki S, Fujio N, Miyasaka K, Kobayashi M (2000) Characterization of the interaction of TZT-1027, a potent antitumour agent, with tubulin. Jpn J Cancer Res 91:737-747
13. Niitani H, Hasegawa K, Furuse K, Fukuoka M, Horikoshi N, Kudoh S (1998) Phase I studies of TZT-1027, a novel inhibitor of tubulin polymerization. Ann Oncol 9 (Suppl 2) Abstr 360
14. Ogawa T, Mimura Y, Isowa K, Kato H, Mitsuishi M, Toyoshi T, Kuwayama N, Morimoto H, Murakoshi M, Nakayama T (2001) An antimicrotubule agent, TZT-1027, does not induce neuropathologic alterations which are detected after administration of vincristine or paclitaxel in animal models. Toxicol Lett 121:97-106
15. Otani M, Natsume T, Watanabe, Kobayashi M, Murakoshi M, Mikami T, Nakayama T (2000) TZT-1027, an antimicrotubule agent, attacks tumor vasculature and induces tumor cell death. Jpn J Cancer Res 91:837-844
16. Pilot HC, McElroy EA, Reid JM, Windebank AJ, Sloan JA, Erlichman C, Bagniewski PG, Walker DL, Rubin J, Goldberg RM, Adjei AA, Ames MM (1999) Phase I trial of dolastatin-10 (NSC 376128) in patients with advanced solid tumors. Clin Cancer Res 5:525-531
17. Pettit GR, Kamano Y, Herald CL, Tuiman AA, Boettner FE, Kizu H, Schmidt JM, Baczynskyj L, Tomer KB, Bontems Rj (1987) The isolation and structure of a remarkable marine animal antineoplastic constituent: dolastatin 10. J Am Chem Soc 109:6883-6885
18. Schoffski P, Thate B, Beutel G, Bolte O, Otto D, Hofman M, Ganser A, Jenner A, Cheverton P, Wanders J, Oguma T, Atsumi R, Satomi M (2004) Phase I and pharmacokinetic study of TZT-1027, a novel synthetic dolastatin 10 derivative, administered as a 1-hour intravenous infusion every 3 weeks in patients with advanced refractory cancer. Ann Oncol 15:671-679
19. Watanabe J, Natsume T, Fujio N, Miyasaka K, Kobayashi M (2000) Induction of apoptosis in human cancer cells by TZT-1027, an antimicrotubule agent. Apoptosis 5:345-353
20. Yamamoto N, Andoh M, Kawahara M, Fukuoka M, Niitani H (2002) Phase I study of TZT-1027, an inhibitor of tubulin polymerization, given weekly x 3 as a 1-hour intravenous infusion in patients (pts) with solid tumors. Proc Am Soc Clin Oncol 21:Abstr 420