Phase I study of intravenous ASA404 (vadimezan) administered in combination with paclitaxel and carboplatin in Japanese patients with non-small cell lung cancer

Cancer Science

Volumn 102, Issue 4, 2011, Pages 845-851

  Hida, Toyoaki ^a   Tamiya, Motohiro ^b   Nishio, Makoto ^c   Yamamoto, Nobuyuki ^d   Hirashima, Tomonori ^b   Horai, Takeshi ^c   Tanii, Hiromi ^e   Shi, Michael M ^f   Kobayashi, Ken ^e   Horio, Yoshitsugu ^a  

^a AICHI CANCER CENTER HOSPITAL   (Japan)

^b OSAKA PREFECTURAL MEDICAL CENTER FOR RESPIRATORY AND ALLERGIC DISEASES   (Japan)

^c CANCER INSTITUTE HOSPITAL   (Japan)

^d SHIZUOKA CANCER CENTER   (Japan)

^e NOVARTIS PHARMA K K   (Japan)

^f NOVARTIS PHARMA AG   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

5 HYDROXYINDOLEACETIC ACID; ANTINEOPLASTIC AGENT; BASIC FIBROBLAST GROWTH FACTOR; CARBOPLATIN; INTERLEUKIN 8; MONOCYTE CHEMOTACTIC PROTEIN 1; PACLITAXEL; PLACENTAL GROWTH FACTOR; VADIMEZAN; VASCULOTROPIN; VASCULOTROPIN RECEPTOR 1; VASCULOTROPIN RECEPTOR 2; VON WILLEBRAND FACTOR;

ADULT; ALOPECIA; ANEMIA; ANOREXIA; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CLINICAL ARTICLE; COLOR VISION DEFECT; CONSTIPATION; DIARRHEA; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG URINE LEVEL; EYE DISEASE; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FEMUR NECK FRACTURE; HEMORRHAGIC COLITIS; HUMAN; HYPONATREMIA; INJECTION SITE PAIN; JAPANESE; LUNG ADENOCARCINOMA; LUNG NON SMALL CELL CANCER; LUNG SQUAMOUS CELL CARCINOMA; LYMPHOCYTOPENIA; MALE; MAXIMUM PLASMA CONCENTRATION; MULTIPLE CYCLE TREATMENT; MYALGIA; NAUSEA; NEUTROPENIA; PERIPHERAL NEUROPATHY; PHARYNGITIS; PHASE 1 CLINICAL TRIAL; PLASMA CONCENTRATION-TIME CURVE; PNEUMONIA; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; QT PROLONGATION; SENSORY NEUROPATHY; SIDE EFFECT; TREATMENT RESPONSE; VISUAL ACUITY;

ADENOCARCINOMA; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; ASIAN CONTINENTAL ANCESTRY GROUP; CARBOPLATIN; CARCINOMA, NON-SMALL-CELL LUNG; CARCINOMA, SQUAMOUS CELL; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASM STAGING; PACLITAXEL; REMISSION INDUCTION; SURVIVAL RATE; TISSUE DISTRIBUTION; TREATMENT OUTCOME; TUMOR MARKERS, BIOLOGICAL; XANTHONES;

EID: 79952762340     PISSN: 13479032     EISSN: 13497006     Source Type: Journal    
DOI: 10.1111/j.1349-7006.2010.01839.x     Document Type: Article

References (37)

1. Ferlay J. Estimates of the cancer incidence and mortality in Europe in 2006. Ann Oncol 2007; 18: 581-92.
2. Parkin DM, Bray F, Ferlay J et al. Global cancer statistics, 2002. CA Cancer J Clin 2005; 55: 74-108.
3. Govindan R. Changing epidemiology of small-cell lung cancer in the United States over the last 30years: analysis of the Surveillance, Epidemiologic, and End Results Database. J Clin Oncol 2006; 24: 4539-43.
4. Subramanian J, Govindan R. Lung Cancer. In: Govindan R, ed. The Washington Manual of Oncology. Philadelphia: Lippincott Williams and Wilkins, 2008; 141.
5. Shibuya K. Global and regional estimates of cancer mortality and incidence by site: II. results for the global burden of disease 2000. BMC Cancer 2002; 2: 1-26.
6. Oshima A, Kuroishi T, Tajima K. Trends of incidence rates of cancer in Japan. White Book of Cancer Statistics: Incidence Death and Prognosis. Tokyo: Shinohara-shinsha, 2005.
7. Toyoda Y, Nakayama T, Ioka A et al. Trends in lung cancer incidence by histological type in Osaka, Japan. Jpn J Clin Oncol 2008; 38: 534-9.
8. Vansteenkiste J, Koester M, Lange M et al. First-line treatment patterns in advanced NSCLC in western Europe (EU), the United States, and Japan including a comparative analysis of younger versus elderly patients. J Clin Oncol 2009; 27: (15 Suppl.): 8053 [abstract].
9. NCCN. Clinical Practice Guidelines in Oncology, v2. NCCN, INC., 2009.
10. NSCLC Meta-Analyses Collaborative Group. Chemotherapy in addition to supportive care improves survival in advanced non-small-cell lung cancer: a systematic review and meta-analysis of individual patient data from 16 randomized controlled trials. J Clin Oncol 2008; 26: 4617-25.
11. Folkman J. What is the evidence that tumors are angiogenesis dependent? J Natl Cancer Inst 1990; 82: 4-6.
12. Ushijima C, Tsukamoto S, Yamazaki K et al. High vascularity in the peripheral region of non-small cell lung cancer tissue is associated with tumor progression. Lung Cancer 2001; 34: 233-41.
13. Cox G, Walker RA, Andi A et al. Prognostic significance of platelet and microvessel counts in operable non-small cell lung cancer. Lung Cancer 2000; 29: 169-77.
14. Fontanini G, Lucci M, Vignati S et al. Angiogenesis as a prognostic indicator of survival in non-small cell lung cancer: a prospective study. J Natl Cancer Inst 1997; 89: 881-6.
15. Meert A-P, Paesmans M, Martin B et al. The role of microvessel density on the survival of patients with lung cancer: a systematic review of the literature and meta-analysis. Br J Cancer 2002; 87: 694-701.
16. Konerding MA, Miodonski AJ, Lametschwandtner A. Microvascular corrosion casting in the study of tumor vascularity: a review. Scanning Microsc 1995; 9: 1233-43.
17. Tozer GM, Kanthou C, Baguley BC. Disrupting tumour blood vessels. Nat Rev Cancer 2005; 5: 423-35.
18. Ching LM, Cao Z, Kieda C et al. Induction of endothelial cell apoptosis by the antivascular agent 5, 6-dimethylxanthenone-4-acetic acid. Br J Cancer 2002; 86: 1937-42.
19. Baguley BC, Ching LM. DMXAA: an antivascular agent with multiple host responses. Int J Radiat Oncol Biol Phys 2002; 54: 1503-11.
20. Ching LM, Goldsmith D, Joseph WR et al. Induction of intratumoral tumor necrosis factor (TNF) synthesis and hemorrhagic necrosis by 5, 6-dimethylxanthenone-4-acetic acid (DMXAA) in TNF knockout mice. Cancer Res 1999; 59: 3304-7.
21. Ching LM, Zwain S, Baguley BC. Relationship between tumour endothelial cell apoptosis and tumour blood flow shutdown following treatment with the antivascular agent DMXAA in mice. Br J Cancer 2004; 90: 906-10.
22. Zwi L, Baguley B, Gavin J et al. Correlation between immune and vascular activities of xanthenone acetic acid antitumor agents. Oncol Res 1994; 6: 79-85.
23. McPhail LD, McIntyre DJ, Ludwig C et al. Rat tumor response to the vascular-disrupting agent 5, 6-dimethylxanthenone-4-acetic acid as measured by dynamic contrast-enhanced magnetic resonance imaging, plasma 5-hydroxyindoleacetic acid levels, and tumor necrosis. Neoplasia 2006; 8: 199-206.
24. Baguley BC, Wilson WR. Potential of DMXAA combination therapy for solid tumors. Expert Rev Anticancer Ther 2002; 2: 593-603.
25. Kelland LR. Targeting established tumour vasculature: a novel approach to cancer treatment. Curr Cancer Ther Rev 2005; 1: 1-9.
26. Siemann DW, Mercer E, Lepler S et al. Vascular targeting agents enhance chemotherapeutic agent activities in solid tumor therapy. Int J Cancer 2002; 99: 1-6.
27. Siim BG, Lee AE, Shalal-Zwain S et al. Marked potentiation of the antitumour activity of chemotherapeutic drugs by the antivascular agent 5, 6-dimethylxanthenone-4-acetic acid (DMXAA). Cancer Chemother Pharmacol 2003; 51: 43-52.
28. Green C, Griffiths-Johnson D, Dunmore K. Marked potentiation of the in vivo antitumor activity of docetaxel in a human prostate cancer xenograft by the vascular targeting agent 5, 6 dimethylxanthenone acetic acid, DMXAA. Proc Amer Assoc Cancer Res 2005; 2990. [abstract].
29. Jameson MB, Thompson PI, Baguley BC et al. Clinical aspects of a phase I trial of 5, 6-dimethylxanthenone-4-acetic acid (DMXAA), a novel antivascular agent. Br J Cancer 2003; 88: 1844-50.
30. McKeage MJ, Fong P, Jeffery M et al. 5, 6-Dimethylxanthenone-4-acetic acid in the treatment of refractory tumors: a phase I safety study of a vascular disrupting agent. Clin Cancer Res 2006; 12: 1776-84.
31. Rustin GJ, Bradley C, Galbraith S et al. 5, 6-dimethylxanthenone-4-acetic acid (DMXAA), a novel antivascular agent: phase I clinical and pharmacokinetic study. Br J Cancer 2003; 88: 1160-7.
32. McKeage MJ, von Pawel J, Reck M et al. Randomised phase II study of ASA404 combined with carboplatin and paclitaxel in previously untreated advanced non-small cell lung cancer. Br J Cancer 2008; 99: 2006-12.
33. 2 combined with carboplatin and paclitaxel in previously untreated advanced non-small cell lung cancer. Lung Cancer 2009; 65: 192-7.
34. McKeage MJ, Jameson MB, AS1404-201 Study Group Investigators. Comparison of safety and efficacy between squamous and non-squamous non-small cell lung cancer (NSCLC) patients in phase II studies of DMXAA (ASA404). ASCO Annual Meeting. Chicago; 2008; 8072 [abstract].
35. Novartis Pharmaceuticals. NCT00662597: a Phase III, randomized, double-blind, placebo-controlled multi-center study of ASA404 in combination with paclitaxel and carboplatin as first-line treatment for locally advanced or metastatic (stage IIIb/IV) non-small cell lung cancer (NSCLC). ATTRACT-1 [cited 4 October 2010], and Available from URL:
36. DePrimo S, Bello C, Smeraglia J et al. Circulating protein biomarkers of pharmacodynamic activity of sunitinib in patients with metastatic renal cell carcinoma: modulation of VEGF and VEGF-related proteins. J Transl Med 2007; 5: 1-11.
37. Rini B, Michaelson M, Rosenberg J et al. Antitumor activity and biomarker analysis of sunitinib in patients with bevacizumab-refractory metastatic renal cell carcinoma. J Clin Oncol 2008; 26: 3743-8.