Phase I/II trial of custirsen (OGX-011), an inhibitor of clusterin, in combination with a gemcitabine and platinum regimen in patients with previously untreated advanced non-small cell lung cancer

Journal of Thoracic Oncology

Volumn 7, Issue 3, 2012, Pages 579-586

  Laskin, Janessa J ^a   Nicholas, Garth ^b   Lee, Christopher ^a   Gitlitz, Barbara ^c   Vincent, Mark ^d   Cormier, Yvon ^e   Stephenson, Joe ^f   Ung, Yee ^g   Sanborn, Rachel ^h   Pressnail, Bryn ⁱ   Nugent, Francis ^j   Nemunaitis, John ^k   Gleave, Martin E ^l   Murray, Nevin ^a   Hao, Desiree ^m  

^a BRITISH COLUMBIA CANCER AGENCY   (Canada)

^b OTTAWA REGIONAL CANCER CENTRE   (Canada)

^c UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^d LONDON REGIONAL CANCER PROGRAM   (Canada)

^e LAVAL UNIVERSITY   (Canada)

^f Cancer Centers of the Carolinas   (United States)

^g DEPARTMENT OF RADIATION ONCOLOGY   (Canada)

^h OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

ⁱ Royal Victoria Hospital Barrie   (Canada)

^j New York Oncology Hematology   (United States)

^k Mary Crowley Medical Research Center   (United States)

^l VANCOUVER PROSTATE CENTRE   (Canada)

^m TOM BAKER CANCER CENTRE   (Canada)

more..

Author keywords

Advanced NSCLC; Antisense oligonucleotide; Biomarker; Chemotherapy; Novel therapeutics

Indexed keywords

ANTINEOPLASTIC AGENT; CARBOPLATIN; CISPLATIN; CUSTIRSEN; DOCETAXEL; ERLOTINIB; GEMCITABINE; HEMOPOIETIC GROWTH FACTOR; LIVER ENZYME; PEMETREXED; PLATINUM;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANEMIA; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; BACTEREMIA; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CANCER SURVIVAL; CEREBRAL BLINDNESS; CEREBROVASCULAR ACCIDENT; CHILL; CONSTIPATION; DECREASED APPETITE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG EFFICACY; DRUG FEVER; DRUG HALF LIFE; DRUG SAFETY; DRUG SUBSTITUTION; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSGEUSIA; DYSPNEA; EMPYEMA; EPISTAXIS; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; GASTROINTESTINAL HEMORRHAGE; HEART INFARCTION; HUMAN; HYPOKALEMIA; HYPONATREMIA; HYPOPHOSPHATEMIA; HYPOTENSION; HYPOXIA; LEUKOPENIA; LOADING DRUG DOSE; LUNG EMBOLISM; LUNG NON SMALL CELL CANCER; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PLEURA EFFUSION; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SEPTICEMIA; SIDE EFFECT; THORAX PAIN; THROMBOCYTE TRANSFUSION; THROMBOCYTOPENIA; THROMBOTIC THROMBOCYTOPENIC PURPURA; TREATMENT DURATION; TREATMENT RESPONSE; VOMITING;

EID: 84857913871     PISSN: 15560864     EISSN: 15561380     Source Type: Journal    
DOI: 10.1097/JTO.0b013e31823f459c     Document Type: Article

References (38)

1. Gleave ME, Monia BP. Antisense therapy for cancer. Nat Rev Cancer 2005;5:468-479. (Pubitemid 40791489)
2. Zoubeidi A, Chi K, Gleave M. Targeting the cytoprotective chaperone, clusterin, for treatment of advanced cancer. Clin Cancer Res 2010;16: 1088-1093.
3. Miyake H, Nelson C, Rennie PS, et al. Acquisition of chemoresistant phenotype by overexpression of the antiapoptotic gene testosteronerepressed prostate message-2 in prostate cancer xenograft models. Cancer Res 2000;60:2547-2554. (Pubitemid 30262451)
4. Miyake H, Chi KN, Gleave ME. Antisense TRPM-2 oligodeoxynucleotides chemosensitize human androgen-independent PC-3 prostate cancer cells both in vitro and in vivo. Clin Cancer Res 2000;6:1655-1663. (Pubitemid 30305057)
5. Zellweger T, Chi K, Miyake H, et al. Enhanced radiation sensitivity in prostate cancer by inhibition of the cell survival protein clusterin. Clin Cancer Res 2002;8:3276-3284. (Pubitemid 35155041)
6. Zellweger T, Kiyama S, Chi K, et al. Overexpression of the cytoprotective protein clusterin decreases radiosensitivity in the human LNCaP prostate tumour model. BJU Int 2003;92:463-469. (Pubitemid 37100531)
7. July LV, Beraldi E, So A, et al. Nucleotide-based therapies targeting clusterin chemosensitize human lung adenocarcinoma cells both in vitro and in vivo. Mol Cancer Ther 2004;3:223-232. (Pubitemid 39193697)
8. Niu L, Zang J, Cai L, et al. [Relationship of clusterin expression with Bax and p53 expression in non-small cell lung cancer]. Zhongguo Fei Ai Za Zhi 2007;10:284-287. (Pubitemid 47435165)
9. Zellweger T, Miyake H, Cooper S, et al. Antitumor activity of antisense clusterin oligonucleotides is improved in vitro and in vivo by incorporation of 2′-O-(2-methoxy)ethyl chemistry. J Pharmacol Exp Ther 2001;298:934-940. (Pubitemid 32761906)
10. Chi KN, Eisenhauer E, Fazli L, et al. A phase I pharmacokinetic and pharmacodynamic study of OGX-011, a 2′-methoxyethyl antisense oligonucleotide to clusterin, in patients with localized prostate cancer. J Natl Cancer Inst 2005;97:1287-1296. (Pubitemid 41535369)
11. Miyake H, Hara I, Gleave ME. Antisense oligodeoxynucleotide therapy targeting clusterin gene for prostate cancer: Vancouver experience from discovery to clinic. Int J Urol 2005;12:785-794. (Pubitemid 41726972)
12. Cao C, Shinohara ET, Li H, et al. Clusterin as a therapeutic target for radiation sensitization in a lung cancer model. Int J Radiat Oncol Biol Phys 2005;63:1228-1236. (Pubitemid 41505304)
13. Scher HI, Halabi S, Tannock I, et al. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol 2008;26:1148-1159.
14. Chi KN, Siu LL, Hirte H, et al. A phase I study of OGX-011, a 2′-methoxyethyl phosphorothioate antisense to clusterin, in combination with docetaxel in patients with advanced cancer. Clin Cancer Res 2008;14:833-839. (Pubitemid 351231167)
15. Schiller JH, Harrington D, Belani CP, et al. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 2002;346:92-98. (Pubitemid 34438899)
16. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000;92:205-216.
17. Saad F, Hotte S, North S, et al. Randomized Phase II Trial of Custirsen (OGX-011) in combination with docetaxel or mitoxantrone as secondline therapy in patients with metastatic castrate-resistant prostate cancer progressing after first-line docetaxel: CUOG Trial P-06c. Clin Cancer Res 2011;17:5765-5773.
18. Zupancic M, Shah PC, Shah-Khan F. Gemcitabine-associated thrombotic thrombocytopenic purpura. Lancet Oncol 2007;8:634-641. (Pubitemid 46995635)
19. Berman IJ, Mann MP. Seizures and transient cortical blindness associated with cis-platinum (II) diamminedichloride (PDD) therapy in a thirty-year-old man. Cancer 1980;45:764-766. (Pubitemid 10174622)
20. Pippitt CH Jr, Muss HB, Homesley HD, et al. Cisplatin-associated cortical blindness. Gynecol Oncol 1981;12:253-255. (Pubitemid 12239330)
21. Jemal A, Siegel R, Ward E, et al. Cancer statistics, 2009. CA Cancer J Clin 2009;59:225-249.
22. Poon S, Easterbrook-Smith SB, Rybchyn MS, et al. Clusterin is an ATP-independent chaperone with very broad substrate specificity that stabilizes stressed proteins in a folding-competent state. Biochemistry 2000;39:15953-15960. (Pubitemid 32038257)
23. Wyatt AR, Yerbury JJ, Wilson MR. Structural characterization of clusterin-chaperone client protein complexes. J Biol Chem 2009;284: 21920-21927.
24. Zhang H, Kim JK, Edwards CA, et al. Clusterin inhibits apoptosis by interacting with activated Bax. Nat Cell Biol 2005;7:909-915. (Pubitemid 41486292)
25. Zoubeidi A, Ettinger S, Beraldi E, et al. Clusterin facilitates COMMD1 and I-kappaB degradation to enhance NF-kappaB activity in prostate cancer cells. Mol Cancer Res 2010;8:119-130.
26. Santilli G, Aronow BJ, Sala A. Essential requirement of apolipoprotein J (clusterin) signaling for IkappaB expression and regulation of NFkappaB activity. J Biol Chem 2003;278:38214-38219. (Pubitemid 37221710)
27. Tereshko V, Portmann S, Tay EC, et al. Correlating structure and stability of DNA duplexes with incorporated 2′-O-modified RNA analogues. Biochemistry 1998;37:10626-10634. (Pubitemid 28357863)
28. Chi KN, Zoubeidi A, Gleave ME. Custirsen (OGX-011): a secondgeneration antisense inhibitor of clusterin for the treatment of cancer. Expert Opin Investig Drugs 2008;17:1955-1962.
29. Sederholm C. Gemcitabine versus gemcitabine/carboplatin in advanced non-small cell lung cancer: preliminary findings in a phase III trial of the Swedish Lung Cancer Study Group. Semin Oncol 2002;29:50-54. (Pubitemid 34753285)
30. Zatloukal P, Petruzelka L, Zemanova M, et al. Gemcitabine plus cisplatin vs. gemcitabine plus carboplatin in stage IIIb and IV non-small cell lung cancer: a phase III randomized trial. Lung Cancer 2003;41:321-331. (Pubitemid 36970188)
31. Mazzanti P, Massacesi C, Rocchi MB, et al. Randomized, multicenter, phase II study of gemcitabine plus cisplatin versus gemcitabine plus carboplatin in patients with advanced non-small cell lung cancer. Lung Cancer 2003;41:81-89. (Pubitemid 36765487)
32. Scagliotti GV, Parikh P, von Pawel J, et al. Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non-small-cell lung cancer. J Clin Oncol 2008;26:3543-3551.
33. Gronberg BH, Bremnes RM, Flotten O, et al. Phase III study by the Norwegian lung cancer study group: pemetrexed plus carboplatin compared with gemcitabine plus carboplatin as first-line chemotherapy in advanced non-small-cell lung cancer. J Clin Oncol 2009;27:3217-3224.
34. Scagliotti GV, De Marinis F, Rinaldi M, et al. Phase III randomized trial comparing three platinum-based doublets in advanced non-small-cell lung cancer. J Clin Oncol 2002;20:4285-4291. (Pubitemid 35266288)
35. Rudd RM, Gower NH, Spiro SG, et al. Gemcitabine plus carboplatin versus mitomycin, ifosfamide, and cisplatin in patients with stage IIIB or IV non-small-cell lung cancer: a phase III randomized study of the London Lung Cancer Group. J Clin Oncol 2005;23:142-153. (Pubitemid 41702633)
36. Giaccone G, Herbst RS, Manegold C, et al. Gefitinib in combination with gemcitabine and cisplatin in advanced non-small-cell lung cancer: a phase III trial-INTACT 1. J Clin Oncol 2004;22:777-784. (Pubitemid 41103588)
37. Le Chevalier T, Scagliotti G, Natale R, et al. Efficacy of gemcitabine plus platinum chemotherapy compared with other platinum containing regimens in advanced non-small-cell lung cancer: a meta-analysis of survival outcomes. Lung Cancer 2005;47:69-80. (Pubitemid 39643243)
38. Numico G, Garrone O, Dongiovanni V, et al. Prospective evaluation of major vascular events in patients with nonsmall cell lung carcinoma treated with cisplatin and gemcitabine. Cancer 2005;103:994-999. (Pubitemid 40270076)