A Phase i clinical study of cisplatin-incorporated polymeric micelles (NC-6004) in patients with solid tumours

British Journal of Cancer

Volumn 104, Issue 4, 2011, Pages 593-598

  Plummer, R ^a   Wilson, R H ^b   Calvert, H ^a,g   Boddy, A V ^a   Griffin, M ^a   Sludden, J ^a   Tilby, M J ^a   Eatock, M ^b   Pearson, D G ^c   Ottley, C J ^c   Matsumura, Y ^d   Kataoka, K ^e   Nishiya, T ^f  

^a NEWCASTLE UNIVERSITY   (United Kingdom)

^b QUEEN'S UNIVERSITY BELFAST   (United Kingdom)

^c DURHAM UNIVERSITY   (United Kingdom)

^d NATIONAL CANCER CENTER HOSPITAL EAST   (Japan)

^e UNIVERSITY OF TOKYO   (Japan)

^f Division of Clinical Study   (Japan)

^g UNIVERSITY COLLEGE LONDON   (United Kingdom)

Author keywords

cisplatin; DDS; EPR effect; NC 6004; phase I study; polymer micelle

Indexed keywords

CHLORPHENIRAMINE; CISPLATIN; CREATININE; DEXAMETHASONE; NC 6004; RANITIDINE; UNCLASSIFIED DRUG;

ABNORMAL SENSATION; ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANOREXIA; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; BURNING SENSATION; CHEMOTHERAPY INDUCED EMESIS; CHEST TIGHTNESS; CLINICAL ARTICLE; CLINICAL PROTOCOL; COLON CANCER; CONSTIPATION; COUGHING; CREATININE CLEARANCE; DECREASED APPETITE; DEHYDRATION; DIZZINESS; DRUG CLEARANCE; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG ELIMINATION; DRUG ERUPTION; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG SAFETY; DYSPNEA; EDEMA; ESOPHAGUS CANCER; FATIGUE; FEMALE; GASTROINTESTINAL STROMAL TUMOR; GLOMERULUS FILTRATION RATE; HUMAN; HYPERHIDROSIS; HYPOMAGNESEMIA; HYPOTENSION; INJECTION SITE REACTION; KIDNEY CANCER; KIDNEY FUNCTION; LIP DISEASE; LIP SWELLING; LIVER CANCER; LUNG CANCER; MALAISE; MALE; MAXIMUM PERMISSIBLE DOSE; MAXIMUM PLASMA CONCENTRATION; MELANOMA; MESOTHELIOMA; MICELLE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEPHROTOXICITY; ORAL PARESTHESIA; PANCREAS CANCER; PERIPHERAL NEUROPATHY; PHARYNX DISEASE; PHARYNX SWELLING; PHASE 1 CLINICAL TRIAL; PLASMA CONCENTRATION-TIME CURVE; PRIORITY JOURNAL; RECOMMENDED DRUG DOSE; SENSORY NEUROPATHY; SIDE EFFECT; SOLID TUMOR; SUSTAINED DRUG RELEASE; SUSTAINED RELEASE FORMULATION; THROMBOCYTOPENIA; TIME TO MAXIMUM PLASMA CONCENTRATION; TINGLING SENSATION; TONGUE EDEMA; TONGUE ULCER; TREATMENT RESPONSE; URTICARIA; XEROSTOMIA;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; CISPLATIN; DISEASE PROGRESSION; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; INJECTIONS, INTRAVENOUS; MALE; MAXIMUM TOLERATED DOSE; MICELLES; MIDDLE AGED; MODELS, BIOLOGICAL; NEOPLASMS; ORGANOPLATINUM COMPOUNDS; POLYGLUTAMIC ACID; POLYMERS;

EID: 79951682119     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/bjc.2011.6     Document Type: Article

References (19)

1. Calvert H, Judson I, Van der Vijgh WJF (1993) Platinum complexes in cancer medicine: pharmacokinetics and pharmacodynamics in relation to toxicity and therapeutic activity. Pharmacokinet Cancer Chemother 17: 189-217
2. Hartmann JT, Lipp H-P (2003) Toxicity of platinum compounds. Expert Opin Pharmacother 4: 889-901 (Pubitemid 36722480)
3. Judson I, Kelland LR (2000) New developments and approaches in the platinum arena. Drugs 59(Suppl. 4): 29-36 (Pubitemid 30344989)
4. Kartalou M, Essigmann JM (2001) Mechanisms of resistance to cisplatin. Mutat Res 478: 23-43 (Pubitemid 32530848)
5. Kelland LR, Sharp SY (1999) Platinum compounds in cancer therapy. Curr Opin Oncol Endocrine Metabolic Invest Drugs 1: 380-385
6. Kitajima K, Fukuoka M, Kobayashi S, Kusunoki Y, Takada M, Negoro S, Matsui K, Sakai N, Ryu S, Takifuji N (1987) Studies on appropriate administration of cisplatin based on pharmacokinetics and toxicity. Jpn J Cancer Chemother 14: 2517-2523 (Pubitemid 18051281)
7. Kwon JS, Elit L, Finn M, Hirte H, Mazurka J, Moens F, Trim K (2002) A comparison of two prophylactic regimens for hypersensitivity reactions to paclitaxel. Gynecol Oncol 84: 420-425 (Pubitemid 34211869)
8. Maeda H (2001) The enhanced permeability and retention (EPR) effect in tumor vasculature: the key role of tumor-selective macromolecular drug targeting. Advan Enzyme Regul 41: 189-207
9. Maeda H, Matsumura Y (1989) Tumoritropic and lymphotropic principles of macromolecular drugs. Crit Rev Ther Drug Carrier Syst 6: 193-210 (Pubitemid 20065994)
10. Maeda H, Wu J, Sawa T, Matsumura Y, Hori K (2000) Tumor vascular permeability and the EPR effect in macromolecular therapeutics: a review. J Control Rel 65: 271-284 (Pubitemid 30122932)
11. Matsumura Y, Maeda H (1986) A new concept for macromolecular therapeutics in cancer chemotherapy: mechanism of tumoritropic accumulation of proteins and the antitumor agent smancs. Cancer Res 46: 6387-6392 (Pubitemid 17221789)
12. Nishiyama N, Kataoka K (2001a) Preparation and characterization of size-controlled polymeric micelle containing cis-dichlorodiammineplatinum (II) in the core. J Control Rel 74: 83-94 (Pubitemid 32727612)
13. Nishiyama N, Kato Y, Sugiyama Y, Kataoka K (2001b) Cisplatin-loaded polymer-metal complex micelle with time-modulated decaying property as a novel drug delivery system. Pharm Res 18: 1035-1041 (Pubitemid 32799952)
14. Nishiyama N, Okazaki S, Cabral H, Miyamoto M, Kato Y, Sugiyama Y, Nishio K, Matsumura Y, Kataoka K (2003) Novel cisplatin-incorporated polymeric micelles can eradicate solid tumors in mice. Cancer Res 63: 8977-8983 (Pubitemid 38064079)
15. Nishiyama N, Yokoyama M, Aoyagi T, Okano T, Sakurai Y, Kataoka K (1999) Preparation and characterization of self-assembled polymer-metal complex micelle from cis-dichlorodiammineplatinum (II) and poly(ethylene glycol)-poly(α,? ¡-aspartic acid) block copolymer in an aqueous medium. Langmuir 15: 377-383
16. Pinzani V, Bressolle F, Hang IJ, Galtier M, Balyac JP, Balmes P (1994) Cisplatin-induced renal toxicity and toxicity-modulating strategies: a review. Cancer Chemother Pharmacol 35: 1-9 (Pubitemid 24356740)
17. Sharp SY, O'Neill CF, Rogers P, Boxall FE, Kelland LR (2002) Retention of activity by the new generation platinum agent AMD0473 in four human tumour cell lines possessing acquired resistance to oxaliplatin. Eur J Cancer 38: 2309-2315 (Pubitemid 35346473)
18. Uchino H, Matsumura Y, Negishi T, Koizumi F, Hayashi T, Honda T, Nishiyama N, Kataoka K, Naito S, Kakizoe T (2005) Cisplatin-incorporating polymeric micelles (NC-6004) can reduce nephrotoxicity and neurotoxicity of cisplatin in rats. Br J Cancer 93: 678-687 (Pubitemid 41486459)
19. Yokoyama M, Okano T, Sakurai Y, Suwa S, Kataoka K (1996) Introduction of cisplatin into polymeric micelle. J Control Rel 39: 351-356 (Pubitemid 26195838)