Phase I study of the c-raf-1 antisense oligonucleotide ISIS 5132 in combination with carboplatin and paclitaxel in patients with previously untreated, advanced non-small cell lung cancer

Journal of Thoracic Oncology

Volumn 4, Issue 9, 2009, Pages 1156-1162

  Fidias, Panos ^a   Pennell, Nathan A ^a   Boral, Anthony L ^a   Shapiro, Geoffrey I ^b   Skarin, Arthur T ^b   Eder Jr , Joseph P ^b   Kwoh, T Jesse ^c   Geary, Richard S ^c   Johnson, Bruce E ^b   Lynch, Thomas J ^a   Supko, Jeffrey G ^a  

^a MASSACHUSETTS GENERAL HOSPITAL   (United States)

^b BRIGHAM AND WOMEN S HOSPITAL   (United States)

^c ISIS PHARMACEUTICALS   (United States)

Author keywords

Chemotherapy; Clinical trials; Human subjects; Pharmacokinetics

Indexed keywords

ANTISENSE OLIGONUCLEOTIDE; C RAF 1 PROTEIN; CARBOPLATIN; CGP 69846A; CREMOPHOR; DEXAMETHASONE; DIPHENHYDRAMINE; DOCETAXEL; GEMCITABINE; HISTAMINE H2 RECEPTOR ANTAGONIST; PACLITAXEL; PLATINUM; RAF PROTEIN; UNCLASSIFIED DRUG;

ADULT; ADVANCED CANCER; AGED; ANEMIA; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; BLEEDING; CANCER CHEMOTHERAPY; CLINICAL ARTICLE; CLINICAL EVALUATION; CLINICAL TRIAL; CONSTIPATION; CONTINUOUS INFUSION; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG INFUSION; FEBRILE NEUTROPENIA; FEMALE; FEVER; HUMAN; HUMAN TISSUE; HYPERSENSITIVITY REACTION; LUNG ADENOCARCINOMA; MALE; MYALGIA; NAUSEA AND VOMITING; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PLASMA CONCENTRATION-TIME CURVE; PRIORITY JOURNAL; PROTEIN EXPRESSION; SIDE EFFECT; SIGNAL TRANSDUCTION; THROMBOCYTOPENIA;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARBOPLATIN; CARCINOMA, NON-SMALL-CELL LUNG; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; PACLITAXEL; PROTO-ONCOGENE PROTEINS C-RAF; THIONUCLEOTIDES;

EID: 69549129386     PISSN: 15560864     EISSN: 15561380     Source Type: Journal    
DOI: 10.1097/JTO.0b013e3181b2793f     Document Type: Article

References (48)

1. American Cancer Society. Cancer facts & figures 2008. Available at: http://www.cancer.org/downloads/STT/2008CAFFfinalsecured.pdf. Accessed January 12, 2009.
2. 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)
3. Daum G, Eisenmann-Tappe I, Fries HW, Troppmair J, Rapp UR. The ins and outs of Raf kinases. Trends Biochem Sci 1994;19:474-480.
4. Beeram M, Patnaik A, Rowinsky EK. Raf: a strategic target for therapeutic development against cancer. J Clin Oncol 2005;23:6771-6790. (Pubitemid 46194105)
5. Stanton VP Jr, Cooper GM. Activation of human Raf transforming genes by deletion of normal amino-terminal coding sequences. Mol Cell Biol 1987;7:1171-1179.
6. Rapp UR, Cleveland JL, Bonner TI, et al. The raf oncogenes. In EP Reddy, AM Skalka, T Curran (Eds.), The Oncogene Handbook. Amsterdam, The Netherlands: Elsevier Science, 1988. Pp 213-253.
7. Monia BP, Johnston JF, Geiger T, Muller M, Fabbro D. Antitumor activity of a phosphorothioate antisense oligodeoxynucleotide targeted against c-raf kinase. Nat Med 1996;2:668-675. (Pubitemid 26191954)
8. Monia BP. Anti-tumor activity of c-raf antisense - correction. Nat Med 1999;5:127.
9. Stevenson JP, Yao KS, Gallagher M, et al. Phase I clinical/ pharmacokinetic and pharmacodynamic trial of the c-raf-1 antisense oligonucleotide ISIS 5132 (CGP 69846A). J Clin Oncol 1999;17:2227-2236. (Pubitemid 29318857)
10. Rudin CM, Holmlund J, Fleming GF, et al. Phase I trial of ISIS 5132, an antisense oligonucleotide inhibitor of c-raf-1, administered by 24-hour weekly infusion to patients with advanced cancer. Clin Cancer Res 2001;7:1214-1220. (Pubitemid 32708672)
11. Cunningham CC, Holmlund JT, Schiller JH, et al. A phase I trial of c-raf kinase antisense oligonucleotide ISIS 5132 administered as a continuous intravenous infusion in patients with advanced cancer. Clin Cancer Res 2000;6:1626-1631.
12. Langer CJ, Leighton JC, Comis RL, et al. Paclitaxel and carboplatin in combination in the treatment of advanced non-small-cell lung cancer: a phase II toxicity, response, and survival analysis. J Clin Oncol 1995;13:1860-1870.
13. Geiger T, Muller M, Monia BP, Fabbro D. Antitumor activity of a c-raf antisense oligonucleotide in combination with standard chemotherapeutic agents against various human tumors transplanted subcutaneously into nude mice. Clin Cancer Res 1997;3:1179-1185. (Pubitemid 27319764)
14. Mullen P, McPhillips F, Monia BP, Smyth JF, Langdon SP. Comparison of strategies targeting raf-1 mRNA in ovarian cancer. Int J Cancer 2006;118:1565-1571. (Pubitemid 43306546)
15. 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.
16. Miller AB, Hoogstraten B, Staquet M, Winkler A. Reporting results of cancer treatment. Cancer 1981;47:207-214.
17. Supko JG, Nair RV, Seiden MV, Lu H. Adaptation of solid phase extraction to an automated column switching method for online sample cleanup as the basis of a facile and sensitive high-performance liquid chromatographic assay for paclitaxel in human plasma. J Pharm Biomed Anal 1999;21:1025-1036.
18. Ghazal-Aswad S, Calvert AH, Newell DR. A single-sample assay for the estimation of the area under the free carboplatin plasma concentration versus time curve. Cancer Chemother Pharmacol 1996;37:429-434. (Pubitemid 26054551)
19. Gabrielsson J, Weiner D. Pharmacokinetic and Pharmacodynamic Data Analysis. Stockholm, Sweden: Swedish Pharmaceutical Press, 1994. Pp 94-99, 621-626.
20. Mizuta E, Tsubotani A. Preparation of mean drug concentration-time curves in plasma. A study on the frequency distribution of pharmacokinetic parameters. Chem Pharm Bull (Tokyo) 1985;33:1620-1632. (Pubitemid 15046092)
21. Lacey LF, Keene ON, Pritchard JF, Bye A. Common noncompartmental pharmacokinetic variables: are they normally or log-normally distributed? J Biopharm Stat 1997;7:171-178. (Pubitemid 27167942)
22. Miller RG. The jacknife - a review. Biometrika 1974;61:1-15.
23. Gianni L, Kearns CM, Giani A, et al. Nonlinear pharmacokinetics and metabolism of paclitaxel and its pharmacokinetic/pharmacodynamic relationships in humans. J Clin Oncol 1995;13:180-190.
24. van der Vijgh WJ. Clinical pharmacokinetics of carboplatin. Clin Pharmacokinet 1991;21:242-261.
25. Goffin JR, Anderson IC, Supko JG, et al. Phase I trial of the matrix metalloproteinase inhibitor marimastat combined with carboplatin and paclitaxel in patients with advanced non-small cell lung cancer. Clin Cancer Res 2005;11:3417-3424. (Pubitemid 40627895)
26. Tolcher AW, Reyno L, Venner PM, et al. A randomized phase II and pharmacokinetic study of the antisense oligonucleotides ISIS 3521 and ISIS 5132 in patients with hormone-refractory prostate cancer. Clin Cancer Res 2002;8:2530-2535. (Pubitemid 34856336)
27. Cripps MC, Figueredo AT, Oza AM, et al. Phase II randomized study of ISIS 3521 and ISIS 5132 in patients with locally advanced or metastatic colorectal cancer: a National Cancer Institute of Canada Clinical Trials Group study. Clin Cancer Res 2002;8:2188-2192. (Pubitemid 34753589)
28. Natale RB. Preliminary results of a phase I/II clinical trial of paclitaxel and carboplatin in non-small cell lung cancer. Semin Oncol 1996;23:2-6. (Pubitemid 26391372)
29. Rowinsky EK, Flood WA, Sartorius SE, Bowling KM, Ettinger DS. Phase I study of paclitaxel on a 3-hour schedule followed by carboplatin in untreated patients with stage IV non-small cell lung cancer. Invest New Drugs 1997;15:129-138. (Pubitemid 27248253)
30. Giaccone G, Splinter TA, Debruyne C, et al. Randomized study of paclitaxel-cisplatin versus cisplatin-teniposide in patients with advanced non-small-cell lung cancer. The European Organization for Research and Treatment of Cancer Lung Cancer Cooperative Group. J Clin Oncol 1998;16:2133-2141.
31. Bonomi P, Kim K, Fairclough D, et al. Comparison of survival and quality of life in advanced non-small-cell lung cancer patients treated with two dose levels of paclitaxel combined with cisplatin versus etoposide with cisplatin: results of an Eastern Cooperative Oncology Group trial. J Clin Oncol 2000;18:623-631. (Pubitemid 30078543)
32. 2) plus carboplatin (6 AUC) in advanced non-small-cell lung cancer (NSCLC): a multicenter randomized trial. Ann Oncol 2000;11:799-805.
33. Glorieux P, Ortmanns P, Marien S, et al. Multi-center study of two dose levels of paclitaxel with carboplatin in locally advanced and metastatic non-small cell lung cancer (NSCLC). Anticancer Res 2001;21:1487-1494. (Pubitemid 32494171)
34. Smit EF, van Meerbeeck JP, Lianes P, et al. Three-arm randomized study of two cisplatin-based regimens and paclitaxel plus gemcitabine in advanced non-small-cell lung cancer: a phase III trial of the European Organization for Research and Treatment of Cancer Lung Cancer Group - EORTC 08975. J Clin Oncol 2003;21:3909-3917. (Pubitemid 46606203)
35. Oza AM, Elit L, Swenerton K, et al. Phase II study of CGP 69846A (ISIS 5132) in recurrent epithelial ovarian cancer: an NCIC clinical trials group study (NCIC IND. 116). Gynecol Oncol 2003;89:129-133. (Pubitemid 36403659)
36. Coudert B, Anthoney A, Fiedler W, et al. Phase II trial with ISIS 5132 in patients with small-cell (SCLC) and non-small cell (NSCLC) lung cancer. A European Organization for Research and Treatment of Cancer (EORTC) Early Clinical Studies Group report. Eur J Cancer 2001;37:2194-2198. (Pubitemid 33001288)
37. Torres K, Horwitz SB. Mechanisms of taxol-induced cell death are concentration dependent. Cancer Res 1998;58:3620-3626. (Pubitemid 28376560)
38. Rasouli-Nia A, Liu D, Perdue S, Britten RA. High Raf-1 kinase activity protects human tumor cells against paclitaxel-induced cytotoxicity. Clin Cancer Res 1998;4:1111-1116. (Pubitemid 28213320)
39. Villalona-Calero MA, Ritch P, Figueroa JA, et al. A phase I/II Study of LY900003, an antisense inhibitor of protein kinase c-α, in combination with cisplatin and gemcitabine in patients with advanced non-small cell lung cancer. Clin Cancer Res 2004;10:6086-6093. (Pubitemid 39287513)
40. Rudin CM, Marshall JL, Huang CH, et al. Delivery of a liposomal c-raf-1 antisense oligonucleotide by weekly bolus dosing in patients with advanced solid tumors: a phase I study. Clin Cancer Res 2004;10:7244-7251.
41. Dritschilo A, Huang CH, Rudin CM, et al. Phase I study of liposome-encapsulated c-raf antisense oligodeoxyribonucleotide infusion in combination with radiation therapy in patients with advanced malignancies. Clin Cancer Res 2006;12:1251-1259. (Pubitemid 43342516)
42. Gridelli C, Rossi A, Mongillo F, Bareschino M, Maione P, Ciardiello F. A randomized phase II study of sorafenib/gemcitabine or sorafenib/erlotinib for advanced non-small-cell lung cancer in elderly patients or patients with a performance status of 2: treatment rationale and protocol dynamics. Clin Lung Cancer 2007;8:396-398. (Pubitemid 46918286)
43. Gridelli C, Maione P, Del Gaizo F, et al. Sorafenib and sunitinib in the treatment of advanced non-small cell lung cancer. Oncologist 2007;12:191-200. (Pubitemid 46271621)
44. Adjei AA, Molina JR, Mandrekar SJ, et al. Phase I trial of sorafenib in combination with gefitinib in patients with refractory or recurrent nonsmall cell lung cancer. Clin Cancer Res 2007;13:2684-2691. (Pubitemid 46788036)
45. Roberts PJ, Der CJ. Targeting the Raf-MEK-ERK mitogen-activated protein kinase cascade for the treatment of cancer. Oncogene 2007;26:3291-3310. (Pubitemid 46763022)
46. Flaherty KT, Brose M, Schuchter L, et al. Phase I/II trial of BAY 43-9006, carboplatin (C) and paclitaxel (P) demonstrates preliminary antitumor activity in the expansion cohort of patients with metastatic melanoma. J Clin Oncol 2004 ASCO Annual Meeting Proceedings; 22(14 Suppl):7507.
47. Schiller JH, Flaherty KT, Redlinger M, et al. Sorafenib combined with carboplatin/-paclitaxel for advanced non-small cell lung cancer: a phase I subset analysis. J Clin Oncol 2006 ASCO Annual Meeting Proceedings; 24(18 Suppl):7194.
48. Bayer and Onyx provide update on phase 3 trial of Nexavar in patients with non-small cell lung cancer. February 18, 2008. Available at: http://www.onyx-pharm.com/wt/page/pr-1203347093. Accessed January 12, 2009.