A phase I study of intravenous TZT-1027 administered on day 1 and day 8 of a three-weekly cycle in combination with carboplatin given on day 1 alone in patients with advanced solid tumours

Annals of Oncology

Volumn 17, Issue 8, 2006, Pages 1313-1319

  Greystoke, A ^a   Blagden, S ^a   Thomas, A L ^c   Scott, E ^c   Attard, G ^a   Molife, R ^a   Vidal, L ^a   Pacey, S ^a   Sarkar, D ^a   Jenner, A ^b   De Bono, J S ^a   Steward, W ^c  

^a ROYAL MARSDEN HOSPITAL   (United Kingdom)

^b Daiichi Pharmaceuticals UK Ltd   (United Kingdom)

^c LEICESTER ROYAL INFIRMARY   (United Kingdom)

Author keywords

Carboplatin; Dolastatin 10 analogue; Phase I; Solid tumours; TZT 1027

Indexed keywords

ALKYLATING AGENT; ANTIBIOTIC AGENT; ANTIEMETIC AGENT; ANTINEOPLASTIC AGENT; AURISTATIN PE; BISPHOSPHONIC ACID DERIVATIVE; CARBOPLATIN; CISPLATIN; DEXAMETHASONE; ERYTHROPOIETIN; GONADORELIN; GRANISETRON; GRANULOCYTE COLONY STIMULATING FACTOR; GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; METOCLOPRAMIDE; MITOMYCIN C; NITROSOUREA;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ANOREXIA; AREA UNDER THE CURVE; AREFLEXIA; ARTICLE; BLOOD TOXICITY; CANCER PATIENT; CLINICAL ARTICLE; CLINICAL OBSERVATION; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DIZZINESS; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG HALF LIFE; DRUG POTENTIATION; FACE DISORDER; FACIAL NERVE PARALYSIS; FATIGUE; FEMALE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; INFECTION; INJECTION SITE PAIN; LEUKOPENIA; LIVER DYSFUNCTION; MALE; MUCOSA INFLAMMATION; NEUROLOGIC DISEASE; NEUTROPENIA; PANCREAS ADENOCARCINOMA; PARALYTIC ILEUS; PARESTHESIA; PERIPHERAL NEUROPATHY; PERONEUS NERVE PARALYSIS; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SENSORY NEUROPATHY; SOLID TUMOR; TASTE DISORDER; THROMBOCYTOPENIA; TREATMENT OUTCOME; VOMITING;

ADULT; AGED; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARBOPLATIN; FEMALE; HUMANS; MALE; MIDDLE AGED; NEOPLASMS; OLIGOPEPTIDES;

EID: 33747894345     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdl097     Document Type: Article

References (18)

1. Pettit GR, Kamano Y, Fujii Y et al. Marine animal biosynthetic constituents for cancer chemotherapy. J Nat Prod 1981; 44: 482-485.
2. 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.
3. 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.
4. Natsume T, Watanabe J, Tamaoke S et al. Characterization of the interaction of TZT-1027, a potent anti-tumor agent, with tubulin. Jpn J Cancer Res 2000; 91: 737-747.
5. Natsume T, Kobayashe 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.
6. Natsume T, Watanabe J, Koh Y et al. Antitumor activity of TZT-1027 (soblidotin) against vascular endothelial growth factor-secreting human lung cancer in vivo. Cancer Sci 2003; 94: 826-833.
7. Hashiguchi N, Kubota T, Koh J et al. TZT-1027 elucidates antitumor activity through direct cytotoxicity and selective blockade of blood supply. Anticancer Res 2004; 24: 2201-2208.
8. Yamamoto N, Andoh M, Kawahara M et al. Phase I study of TZT-1027, an inhibitor of tubulin polymerization, given weekly×3 as a 1-hour intravenous infusion in patients (pts) with solid tumors. Proc Am Soc Clin Onc 2002; 21: 106a (Abstr 420).
9. Schöffski P, Thate B, Beutel G et al. 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 2004; 15: 671-679.
10. de Jonge MJ, van der Gaast A, Planting AS et al. 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 2005; 11: 3806-3813.
11. Cockcroft D, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976; 16: 31-41.
12. Therasse P, Arbuck SG, Eisenhauer EA et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000; 92: 205-216.
13. National Cancer Institute Common Terminology Criteria for Adverse Events v3.0 2003 http://ctep.cancer.gov/forms/CTCAEv3.pdf
14. Calvert AH, Newell DR, Gumbrell LA et al. Carboplatin dosage: prospective evaluation of a simple formula based on renal function. J Clin Oncol 1989; 7: 1748-1756.
15. Newell DR, Siddik ZH, Gumbrell LA et al. Plasma free platinum pharmacokinetics in patients treated with high dose carboplatin. Eur J Cancer Clin Oncol 1987; 23: 1399-1405.
16. Ranganathan S, Dexter DW, Benetatos CA et al. Increase of βIII- and βIVa-tubulin in human prostate carcinoma cells as a result of estramustine resistance. Cancer Res 1996; 56: 2584-2589.
17. Greenberger LM, Lothstein L, Williams SS, Horwitz SB. Distinct P-glycoprotein precursors are overproduced in independently isolated drug-resistant cell lines. Proc Natl Acad Sci USA. 1988; 85: 3762-3776.
18. 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.