Randomized phase II evaluation of aprinocarsen in combination with gemcitabine and cisplatin for patients with advanced/metastatic non-small cell lung cancer

Investigational New Drugs

Volumn 23, Issue 3, 2005, Pages 263-269

  Vansteenkiste, Johan ^a   Canon, Jean Luc ^b   Riska, Henrik ^c   Pirker, Robert ^d   Peterson, Patrick ^e   John, William ^e   Mali, Pekka ^f   Lahn, Michael ^e  

^a UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^b Centre Hospitalier Notre Dame et Reine Fabiola   (Belgium)

^c HELSINKI UNIVERSITY CENTRAL HOSPITAL   (Finland)

^d MEDICAL UNIVERSITY OF VIENNA   (Austria)

^e ELI LILLY AND COMPANY   (United States)

^f TURKU UNIVERSITY HOSPITAL   (Finland)

Author keywords

Aprinocarsen; Cisplatin; Gemcitabine; Non small cell lung cancer; Phase II

Indexed keywords

APRINOCARSEN; CARBOPLATIN; CISPLATIN; ERYTHROPOIETIN; GEMCITABINE; GROWTH FACTOR; PACLITAXEL; PROTEIN KINASE C INHIBITOR; UNCLASSIFIED DRUG;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ANOREXIA; ARTICLE; ASTHENIA; CANCER CHEMOTHERAPY; CANCER STAGING; CANCER SURVIVAL; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DYSPNEA; EVALUATION; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HEARING LOSS; HUMAN; HYPERTENSION; INFECTION; LUNG NON SMALL CELL CANCER; MALE; NAUSEA; NEUROTOXICITY; NEUTROPENIA; PERICARDIAL EFFUSION; PHASE 2 CLINICAL TRIAL; PLEURA EFFUSION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; THROMBOCYTOPENIA;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, NON-SMALL-CELL LUNG; CISPLATIN; DEOXYCYTIDINE; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; OLIGONUCLEOTIDES, ANTISENSE;

EID: 18844365940     PISSN: 01676997     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10637-005-6736-x     Document Type: Article

References (23)

1. Ferlay J, Bray P, Pisani P, Parkin DM: GLOBOCAN 2000: Cancer Incidence, Mortality and Prevalence Worldwide (ed Version 1). IARC CancerBase No. 5, IARC Press Lyon, 2001
2. Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH, The Eastern Cooperative Oncology Group: Comparison of 4 chemotherapy regimens for advanced non-small cell lung cancer. N Engl J Med 346: 92-98, 2002
3. Dy GK, Adjei AA: Novel targets for lung cancer therapy: Part I. J Clin Oncol 20: 2881-2894, 2002
4. Davies AM, Gandara D, Lara P, Mack P, Lau D, Gumerlock P: Antisense Oligonucleotides in the Treatment of NSCLC. Clin Lung Cancer 4: S68-S73, 2003
5. Tamm I, Dorken B, Hartmann G: Antisense therapy in oncology: New hope for an old idea? Lancet 358: 489-497, 2001
6. Crooke ST: Basic Principles of Antisense Technology; In: Crooke ST (ed) Antisense Drug Technology: Principles, Strategies, and Applications. Marcel Dekker, New York, 2001, pp. 1-28
7. Basu A: The potential of protein kinase C as a target for anticancer treatment. Pharmacol Ther 59: 257-280, 1993
8. Dean NM, McKay R, Condon TP, Bennett CF: Inhibition of protein kinase C-alpha expression in human A549 cells by antisense oligonucleotides inhibits induction of intercellular adhesion molecule 1 (ICAM-1) mRNA by phorbol esters. J Biol Chem 269: 16416-16424, 1994
9. Lahn M, Sundell K, Moore S: Targeting protein kinase C-alpha (PKC-alpha) in cancer with the phosphorothioate antisense oligonucleotide aprinocarsen. Ann N Y Acad Sci 1002: 263-270, 2003
10. Yuen AR, Halsey J, Fisher GA, Advani R, Moore M, Saleh M, Ritch P, Harker G, Ahmed F, Jones CM, Polikoff J, Keiser W, Kwoh TJ, Holmlund JT, Dorr A, Sikic BI: Phase I/II trial of ISIS 3521, an antisense inhibitor of PKC-alpha, with carboplatin and paclitaxel in non-small cell lung cancer. (Abstract) Proc Am Soc Clin Oncol 20: 309a, 2001
11. Sikic BI, Yuen AR, Advani R, Halsey J, Fisher GA, Holmlund J, Dorr A: Antisense oligonucleotide therapy targeted to protein kinase C-alpha (ISIS 3521/CGP 64128A) by 21-day infusion: Results of the phase I trail and activity in ovarian carcinoma. (Abstract) Proc Am Soc Clin Oncol 17: 429a, 1998
12. Nemunaitis J, Holmlund JT, Kraynak M, Richards D, Bruce J, Ognoskie N, Kwoh TJ, Geary R, Dorr A, Von Hoff D, Eckhardt SG: Phase I evaluation of ISIS 3521 (ISI 641A), an antisense oligodeoxynucleotide to protein kinase C-α, in patients with advanced cancer. J Clin Oncol 17: 3586-3595, 1999
13. Sandler A. State-of-the-art treatment for advanced non-small cell lung cancer. Oncology 17: 15-22, 2003
14. Ritch PS, Belt R, George S, Valdivieso M, Figueroa J, McCachren S, Modiano M, Miller GL, Leonardo J, Dorr A, Oliver JW, Holmlund J, Otterson GA, Villanola-Calero MA: Phase I/II trial of ISIS 3521/LY9000003, an antisense inhibitor of PKC-alpha with cisplatin and gemcitabine in advanced non-small cell lung cancer (NSCLC). (Abstract) Proc Am Soc Clin Oncol 21: 309a, 2002
15. Lynch TJ, Raju R, Lind M, Riviere A, Gatzemeier U, Dorr A, Holmlund J, Yuen A, Sikic BI: Randomized phase III trial of chemotherapy and antisense, oligonucleotide LY9000003 (ISIS 3521) in patients with advanced NSCLC: Initial report. (Abstract) Proc Am Soc Clin Oncol 22: 623, 2003
16. Therasse P, Arbuck SG, Eisenhauer LA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG: 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 92: 205-16, 2000
17. Gatzemeier U, Groth G, Butts C, van Zandwijk N, Shepherd F, Ardizzoni A, Barton C, Ghahramani P, Hiwasa T: Randomized phase II trial of gemcitabine-cisplatin with or without trastuzumab in HER2-positive non-small cell lung cancer. Ann Oncol 15: 19-27, 2004
18. Andre F, Le Chevalier T, Soria JC: Her2-neu a target in lung cancer? Ann Oncol 15: 3-4, 2004
19. O'Grady NP, Alexander M, Dellinger EP, Gerberding JL, Heard SO, Maki DG, Masur H, McCormick RD, Mermel LA, Pearson ML, Raad II, Randolph A, Weinstein RA: Guidelines for the prevention of intravascular catheter-related infections. Centers for Disease Control and Prevention. Morbidity & Mortality Weekly Report Recommendations & Reports 51: 1-29, 2002
20. World Health Organization: Guidelines on Prevention and Control of Hospital-Acquired Infections. SEA-HLM-343. New Delhi, India, World Health Organization, 2002
21. Anderson N, Lokich J, Bern M, Wallach S, Moore C, Williams D: A phase I clinical trial of combined fluoropyrimidines with leucovorin in a 14-day infusion. Demonstration of biochemical modulation. Cancer 63: 233-237, 1989
22. Lokich J, Bern M, Anderson N, Wallach S, Moore C, Beauchamp K, Williams D: Cyclophosphamide, methotrexate, and 5-fluorouracil in a three-drug admixture. Phase I trial of 14-day continuous ambulatory infusion. Cancer 63: 822-824, 1989
23. Peterson P, Iturria N, Sundell K, Lahn M: Meta-analysis of Infection During Continuous Infusion Chemotherapy With Minimal Infusate Changes. (Abstract) Lung Cancer 41 (Suppl): 140S, 2003