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

Annals of Oncology

Volumn 15, Issue 4, 2004, Pages 671-679

  Schöffski, Patrick ^a   Thate, B ^a   Beutel, G ^a   Bolte, O ^a   Otto, D ^a   Hofmann, M ^a   Ganser, A ^a   Jenner, A ^b   Cheverton, P ^b   Wanders, J ^b   Oguma, T ^c   Atsumi, R ^c   Satomi, M ^c  

^a HANNOVER MEDICAL SCHOOL   (Germany)

^b Daiichi Pharmaceuticals UK Ltd   (United Kingdom)

^c DAIICHI SANKYO CO   (Japan)

Author keywords

Dolastatins; Phase I study; Solid tumors; TZT 1027

Indexed keywords

ANTIEMETIC AGENT; ANTINEOPLASTIC AGENT; ASPARTATE AMINOTRANSFERASE; AURISTATIN PE; CAPECITABINE; CARBOPLATIN; CISPLATIN; CREATININE; DOLASTATIN 10 DERIVATIVE; DOXORUBICIN; ETOPOSIDE; FLUOROPYRIMIDINE; FLUOROURACIL; FOLINIC ACID; GEMCITABINE; IFOSFAMIDE; IRINOTECAN; MITOMYCIN C; NITROSOUREA; OXALIPLATIN; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ADULT; ADVANCED CANCER; AGE; AGED; AGITATION; ALOPECIA; ANEMIA; ANOREXIA; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; BLOOD TOXICITY; BONE MARROW; CLINICAL ARTICLE; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE ASSOCIATION; DISEASE DURATION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE REGIMEN; DRUG EXPOSURE; DRUG HALF LIFE; DRUG INFUSION; DRUG RESPONSE; DRUG SAFETY; DRUG STRUCTURE; DRUG URINE LEVEL; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; GENDER; HEADACHE; HEART FUNCTION; HUMAN; HYPERBILIRUBINEMIA; HYPOCHLOREMIA; HYPONATREMIA; INSOMNIA; KIDNEY FUNCTION; LEUKOPENIA; LINEAR SYSTEM; LIVER FUNCTION; MALE; MAXIMUM TOLERATED DOSE; MUSCLE CRAMP; NAUSEA; NEUROTOXICITY; NEUTROPENIA; NEUTROPHIL; PAIN; PARESTHESIA; PATIENT SELECTION; PERFORMANCE; PERIPHERAL NEUROPATHY; PHARMACODYNAMICS; PHASE 1 CLINICAL TRIAL; PHLEBITIS; PRIORITY JOURNAL; SIDE EFFECT; SOLID TUMOR; TASTE DISORDER; THROMBOCYTE; THROMBOCYTOPENIA; TRISMUS; VOMITING;

ADULT; AGED; ALOPECIA; ANOREXIA; ANTINEOPLASTIC AGENTS; AREA UNDER CURVE; CONSTIPATION; DOSE-RESPONSE RELATIONSHIP, DRUG; FATIGUE; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; LEUKOPENIA; MALE; MIDDLE AGED; NAUSEA; NEOPLASMS; NEUTROPENIA; OLIGOPEPTIDES;

EID: 18144432660     PISSN: 09237534     EISSN: None     Source Type: Journal    
DOI: 10.1093/annonc/mdh141     Document Type: Article

References (25)

1. Miyazaki K, Kobayashi M, Natsume T et al. Synthesis and antitumour activity of novel dolastatin analogs. Chem Pharm Bull 1995; 43: 1706-1718.
2. Pettit GR, Kamano Y, Herald CL et al. The isolation and structure of a ressrkable marine animal antineoplastic constituent: dolastatin 10. J Am Chem Soc 1987; 109: 6883-6885.
3. Pettit GR, Singh SB, Hogan F et al. The absolute configuration and synthesis of natural dolastatin 10. J Am Chem Soc 1987; 111: 5463-5465.
4. Pettit GR, Kamano Y, Herald CL et al. Isolation of dolastatin 10-15 from the marine mollusk Dolabella auricularia. Tetrahedron 1993; 49: 9152-9170.
5. Hamada Y, Hayashi K, Shiori T. Efficient stereoselective synthesis of dolastatin 10, an antineoplastic peptide from a sea hare. Tetrahedron Lett 1991; 32: 931-934.
6. Kobayashi M, Natsume T, Tamaoki S et al. Antitumor activity of TZT-1027, a novel dolastatin 10 derivative. Jpn J Cancer Res 1997; 88: 316-327.
7. Kobayashi M, Natsume T, Watanabe J et al. Activity of a novel antitumor agent, TZT-1027. Nippon Yakurigaku Zasshi 1999; 114 (Suppl 1): 230P-235P.
8. Natsume T, Kobayashi M, Fujimoto S. Association of p53 gene mutations with sensitivity to TZT-1027 in patients with clinical lung and renal carcinoma. Cancer 2001; 92: 386-394.
9. Watanabe J, Natsume T, Fujio N et al. Induction of apoptosis in human cancer cells by TZT-1027, an antimicrotubule agent. Apoptosis 2000; 5: 345-353.
10. Niitani H, Hasegawa K. Phase I studies of TZT-1027, a novel inhibitor of tubulin polymerization. Ann Oncol 1998; 9 (Suppl 2) (Abstr 360).
11. Yamamoto N, Andoh M. Phase I study of TZT-1027, an inhibitor of tubulin polymerization, given weekly × 3 as a 1-hour intravenous infusion in patients with solid tumors. Proc Am Soc Clin Oncol 2002; 93 (Abstr 420).
12. Horti J, Juhasz E, Bodrogi I. Preliminary results of a Phase I trial of TZT-1027, an inhibitor of tubulin polymerization, in patients with advanced non-small cell lung cancer. Proc Am Assoc Cancer Res 2002; 93 (Abstr 2744).
13. Therasse P, Arbuck SG, Eisenhauer EA et al. New guidelines to evaluate the response to treatment of solid tumors. J Natl Cancer Inst 2000; 92: 205-216.
14. 18F]-fluorodeoxyglucose and positron emission tomography. Review and 1999 EORTC recommendations. Eur J Cancer 1999; 35: 1773-1782.
15. Ochiai H, Mori H, Murata H et al. Validation of an analytical method for a potent antitumor agent, TZT-1027, in plasma using liquid chromatography-mass spectrometry. J Chromatogr B Biomed Sci Appl 2001; 762: 155-163.
16. Oguma T, Atsumi R. TZT-1027: validation of a high performance liquid chromatographic mass spectrometric method for the determination of TZT-1027 in human plasma. Daiichi Pharmaceutical Co. Ltd. Study Report No. 20010582, 26 December 2001.
17. Oguma T, Atsumi R. TZT-1027: validation of a high performance liquid chromatographic mass spectrometric method for the determination of TZT-1027 in human urine. Daiichi Pharmaceutical Co. Ltd. Study Report No: 20010583, 26 December 2001.
18. Pitot HC, Frytak S, Croghan GA et al. Phase II study of dolastatin-10 (dola-10) in patients (pts) with advanced renal cell cancer. Proc Am Soc Clin Oncol 2002; 20 (Abstr 2409).
19. Fujita F, Koike M, Fujita M et al. Antitumor effects of TZT-1027, a novel dolastatin 10 derivative, on human xenografts in nude mice. Gan to Kagaku Ryoho 2000; 27: 451-458.
20. Natsume T, Watanabe J, Tamaoki S et al. Characterization of the interaction of TZT-1027, a potent antitumor agent, with tubulin. Jpn J Cancer Res 2000; 91: 737-747.
21. Natsume T, Nakamura T, Koh Y et al. Gene expression profiling of exposure to TZT-1027, a novel microtubule-interfering agent, in non-small cell lung cancer PC-14 cells and astrocytes. Invest New Drugs 2001; 19: 292-302.
22. Otani M, Natsume T, Watanabe JI et al. TZT-1027, an antimicrotubule agent, attacks tumor vasculature and induces tumor cell death. Jpn J Cancer Res 2000; 91: 837-844.
23. Gamelin E, Gamelin L, Bossi L, Quasthoff S. Clinical aspects and molecular basis of oxaliplatin neurotoxicity: current management and development of preventive measures. Semin Oncol 2002; 29 (Suppl 15): 21-33.
24. Gornet JM, Savier E, Lociec F et al. Exacerbation of oxaliplatin neurosensory toxicity following surgery. Ann Oncol 2002; 13: 1315-1318.
25. Ogawa T, Mimura Y, Isowa K et al. An antimicrotubule agent, TZT-1027, does not induce neuropathologic alterations which are detected after administration of vincristine or paclitaxel in animal models. Toxicol Lett 2001; 121: 97-106.