A phase i trial and in vitro studies combining ABT-751 with carboplatin in previously treated non-small cell lung cancer patients

Chemotherapy

Volumn 58, Issue 4, 2012, Pages 321-329

  Ma, Tian ^a   Fuld, Alexander D ^a   Rigas, James R ^a,b   Hagey, Anne E ^c   Gordon, Gary B ^c   Dmitrovsky, Ethan ^a,b   Dragnev, Konstantin H ^a,b  

^a DARTMOUTH MEDICAL SCHOOL   (United States)

^b DARTMOUTH HITCHCOCK MEDICAL CENTER   (United States)

^c ABBOTT LABORATORIES   (United States)

Author keywords

ABT 751; Carboplatin; Non small cell lung cancer; Phase I clinical trial

Indexed keywords

AMINOTRANSFERASE; CARBOPLATIN; CYCLIN D1; N [2 [(4 HYDROXYPHENYL)AMINO] 3 PYRIDINYL] 4 METHOXYBENZENESULFONAMIDE;

ADULT; ANEMIA; ANTINEOPLASTIC ACTIVITY; APOPTOSIS; ARTICLE; CANCER CELL CULTURE; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER SURVIVAL; CELL GROWTH; CHEMOTHERAPY INDUCED NAUSEA AND VOMITING; CLINICAL ARTICLE; COHORT ANALYSIS; CONFUSION; CONSTIPATION; CONTROLLED STUDY; DEHYDRATION; DRUG CYTOTOXICITY; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; DRUG WITHDRAWAL; DYSPEPSIA; DYSPNEA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HUMAN; HUMAN CELL; HYPERLIPIDEMIA; HYPOKALEMIA; HYPONATREMIA; HYPOPHOSPHATEMIA; ILEUS; IN VITRO STUDY; INFECTION; LEUKOPENIA; LUNG NON SMALL CELL CANCER; MALE; MAXIMUM TOLERATED DOSE; MULTIPLE CYCLE TREATMENT; MYALGIA; NEUROLOGIC DISEASE; NEUROPATHY; NEUTROPENIA; OVERALL SURVIVAL; PAIN; PHASE 1 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; SIDE EFFECT; SURVIVAL TIME; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT RESPONSE; WEAKNESS;

ADMINISTRATION, ORAL; AGED; ANTINEOPLASTIC AGENTS; APOPTOSIS; AREA UNDER CURVE; CARBOPLATIN; CARCINOMA, NON-SMALL-CELL LUNG; CELL LINE, TUMOR; CYCLIN D1; DRUG THERAPY, COMBINATION; FATIGUE; FEMALE; HUMANS; ILEUS; LUNG NEOPLASMS; MALE; MIDDLE AGED; NEUTROPENIA; PNEUMONIA; SULFONAMIDES; SURVIVAL RATE;

EID: 84868605513     PISSN: 00093157     EISSN: 14219794     Source Type: Journal    
DOI: 10.1159/000343165     Document Type: Article

References (43)

1. Garcia M, Jemal A, Ward EM, Center MM, Hao Y, Siegel RL, Thun MJ: Global Cancer Facts & Figures 2007. Atlanta, American Cancer Society, 2007.
2. Pfister DG, Johnson DH, Azzoli CG, Sause W, Smith TJ, Baker S Jr, Olak J, Stover D, Strawn JR, Turrisi AT, Somerfield MR: American Society of Clinical Oncology Treatment of unresectable non-small-cell lung cancer guideline: update 2003. J Clin Oncol 2004; 22: 330-353.
3. Socinski MA, Crowell R, Hensing TE, Langer CJ, Lilenbaum R, Sandler AB, Morris D: American College of Chest Physicians Treatment of non-small cell lung cancer, stage IV: ACCP evidence-based clinical practice guidelines (2nd edition). Chest 2007; 132: 277S-289S.
4. National Comprehensive Cancer Network. The NCCN Clinical Practice Guidelines in Oncology: Non-Small Cell Lung Cancer (v. 2.2013). Fort Washington, National Comprehensive Cancer Network, 2012.
5. Komuta K, Osaki T, Mori M, Yokota S, Tanio Y, Matsui K, Imamura F, Kawase I: A phase II study directed by a clinical pathway for carboplatin and weekly paclitaxel in previously untreated patients with unresectable non-small cell lung cancer. Chemotherapy 2010; 56: 39-45.
6. Azzoli CG, Baker S Jr, Temin S, Pao W, Aliff T, Brahmer J, Johnson DH, Laskin JL, Masters G, Milton D, Nordquist L, Pfister DG, Piantadosi S, Schiller JH, Smith R, Smith TJ, Strawn JR, Trent D, Giaccone G: American Society of Clinical Oncology Clinical Practice Guideline update on chemotherapy for stage IV non-small cell lung cancer. J Clin Oncol 2009; 27: 6251-6266.
7. Imamura F, Nishio M, Noro R, Tsuboi M, Ikeda N, Inoue A, Ohsaki Y, Kimura Y, Nishino K, Uchida J, Horai T: Randomized phase II study of two schedules of carboplatin and gemcitabine for stage IIIB and IV advanced non-small cell lung cancer (JACCRO LC-01 study). Chemotherapy 2011; 57: 357-362.
8. Fossella F, Pereira JR, von Pawel J, Pluzanska A, Gorbounova V, Kaukel E, Mattson KV, Ramlau R, Szczesna A, Fidias P, Millward M, Belani CP: Randomized, multinational, phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for advanced non-small-cell lung cancer: the TAX 326 study group. J Clin Oncol 2003; 21: 3016-3024.
9. Huisman C, Smit EF, Giaccone G, Postmus PE: Second-line chemotherapy in relapsing or refractory non-small-cell lung cancer: a review. J Clin Oncol 2000; 18: 3722-3730.
10. Shepherd FA, Dancey J, Ramlau R, Mattson K, Gralla R, O'Rourke M, Levitan N, Gressot L, Vincent M, Burkes R, Coughlin S, Kim Y, Berille J: Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol 2000; 18: 2095-2103.
11. Hanna N, Shepherd FA, Fossella FV, Pereira JR, De Marinis F, von Pawel J, Gatzemeier U, Tsao TC, Pless M, Muller T, Lim HL, Desch C, Szondy K, Gervais R, Shaharyar, Manegold C, Paul S, Paoletti P, Einhorn L, Bunn PA Jr: Randomized phase III trial of pemetrexed versus docetaxel in patients with nonsmall-cell lung cancer previously treated with chemotherapy. J Clin Oncol 2004; 22: 1589-1597.
12. Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, van Kooten M, Dediu M, Findlay B, Tu D, Johnston D, Bezjak A, Clark G, Santabárbara P, Seymour L: Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 2005; 353: 123-132.
13. Kim ES, Hirsh V, Mok T, Socinski MA, Gervais R, Wu YL, Li LY, Watkins CL, Sellers MV, Lowe ES, Sun Y, Liao ML, Osterlind K, Reck M, Armour AA, Shepherd FA, Lippman SM, Douillard JY: Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial. Lancet 2008; 372: 1809-1818.
14. Chung FT, Lee KY, Fang YF, Shieh MH, Lin SM, Yu CT, Lo YL, Lin TY, Kuo CH, Feng PH, Ni YL, Kuo HP: Low-dose weekly docetaxel is as tolerable as pemetrexed in previously treated advanced non-small-cell lung cancer. Chemotherapy 2011; 57: 147-155.
15. Lee J, Harris L: Antimicrotubule agents; in DeVita VT Jr, Lawrence TSR, Rosenberg SA (eds): Devita, Hellman and Rosenberg's Cancer: Principles and Practice of Oncology. Philadelphia, Lippincott, Williams & Wilkins, 2008, pp 447-456.
16. Yoshino H, Ueda N, Niijima J, Sugumi H, Kotake Y, Koyanagi N, Yoshimatsu K, Asada M, Watanabe T, Nagasu T, Tsukahara K, Iijima A, Kitoh K: Novel sulfonamides as potential, systemically active antitumor agents. J Med Chem 1992; 35: 2496-2497.
17. Yoshimatsu K, Yamaguchi A, Yoshino H, Koyanagi N, Kitoh K: Mechanism of action of E7010, an orally active sulfonamide antitumor agent: inhibition of mitosis by binding to the colchicine site of tubulin. Cancer Res 1997; 57: 3208-3213.
18. Segreti JA, Polakowski JS, Koch KA, Marsh KC, Bauch JL, Rosenberg SH, Sham HL, Cox BF, Reinhart GA: Tumor selective antivascular effects of the novel antimitotic compound ABT-751: an in vivo rat regional hemodynamic study. Cancer Chemother Pharmacol 2004; 54: 273-281.
19. Luo Y, Hradil VP, Frost DJ, Rosenberg SH, Gordon GB, Morgan SJ, Gagne GD, Cox BF, Tahir SK, Fox GB: ABT-751, a novel tubulinbinding agent, decreases tumor perfusion and disrupts tumor vasculature. Anticancer Drugs 2009; 20: 483-492.
20. Koyanagi N, Nagasu T, Fujita F, Watanabe T, Tsukahara K, Funahashi Y, Fujita M, Taguchi T, Yoshino H, Kitoh K: In vivo tumor growth inhibition produced by a novel sulfonamide, E7010, against rodent and human tumors. Cancer Res 1994; 54: 1702-1706.
21. Morton CL, Favours EG, Mercer KS, Boltz CR, Crumpton JC, Tucker C, Billups CA, Houghton PJ: Evaluation of ABT-751 against childhood cancer models in vivo. Invest New Drugs 2007; 25: 285-295.
22. Galmarini CM: ABT-751 (Abbott). Curr Opin Investig Drugs 2005; 6: 623-630.
23. Fox E, Maris JM, Widemann BC, Meek K, Goodwin A, Goodspeed W, Kromplewski M, Fouts ME, Medina D, Cho SY, Cohn SL, Krivoshik A, Hagey AE, Adamson PC, Balis FM: A phase 1 study of ABT-751, an orally bioavailable tubulin inhibitor, administered daily for 7 days every 21 days in pediatric patients with solid tumors. Clin Cancer Res 2006; 12: 4882-4887.
24. Fox E, Maris JM, Widemann BC, Goodspeed W, Goodwin A, Kromplewski M, Fouts ME, Medina D, Cohn SL, Krivoshik A, Hagey AE, Adamson PC, Balis FM: A phase I study of ABT-751, an orally bioavailable tubulin inhibitor, administered daily for 21 days every 28 days in pediatric patients with solid tumors. Clin Cancer Res 2008; 14: 1111-1115.
25. Hande KR, Hagey A, Berlin J, Cai Y, Meek K, Kobayashi H, Lockhart AC, Medina D, Sosman J, Gordon GB, Rothenberg ML: The pharmacokinetics and safety of ABT-751, a novel, orally bioavailable sulfonamide antimitotic agent: results of a phase 1 study. Clin Cancer Res 2006; 12: 2834-2840.
26. Yamamoto K, Noda K, Yoshimura A, Fukuoka M, Furuse K, Niitani H: Phase I study of E7010. Cancer Chemother Pharmacol 1998; 42: 127-134.
27. Yee KW, Hagey A, Verstovsek S, Cortes J, Garcia-Manero G, O'Brien SM, Faderl S, Thomas D, Wierda W, Kornblau S, Ferrajoli A, Albitar M, McKeegan E, Grimm DR, Mueller T, Holley-Shanks RR, Sahelijo L, Gordon GB, Kantarjian HM, Giles FJ: Phase 1 study of ABT-751, a novel microtubule inhibitor, in patients with refractory hematologic malignancies. Clin Cancer Res 2005; 11: 6615-6624.
28. Michels J, Ellard SL, Le L, Kollmannsberger C, Murray N, Tomlinson Guns ES, Carr R, Chi KN: A phase IB study of ABT-751 in combination with docetaxel in patients with advanced castration-resistant prostate cancer. Ann Oncol 2010; 21: 305-311.
29. Jorgensen TJ, Tian H, Joseph IB, Menon K, Frost D: Chemosensitization and radiosensitization of human lung and colon cancers by antimitotic agent, ABT-751, in athymic murine xenograft models of subcutaneous tumor growth. Cancer Chemother Pharmacol 2007; 59: 725-732.
30. Rosell R, Gatzemeier U, Betticher DC, Keppler U, Macha HN, Pirker R, Berthet P, Breau JL, Lianes P, Nicholson M, Ardizzoni A, Chemaissani A, Bogaerts J, Gallant G: Phase III randomised trial comparing paclitaxel/carboplatin with paclitaxel/cisplatin in patients with advanced non-small-cell lung cancer: a cooperative multinational trial. Ann Oncol 2002; 13: 1539-1549.
31. Zatloukal P, Petruzelka L, Zemanová M, Kolek V, Skricková J, Pesek M, Fojt? H, Grygárková I, Sixtová D, Roubec J, Horenková E, Havel L, Pr?sa P, Nováková L, Skácel T, K?ta M: 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.
32. Petty WJ, Dragnev KH, Memoli V, Ma Y, Desai NB, Biddle A, Davis TH, Nugent WC, Memoli N, Hamilton M, Iwata KK, Rigas JR, Dmitrovsky E: Epidermal growth factor receptor tyrosine kinase inhibition represses cyclin D1 in aerodigestive tract cancers. Clin Cancer Res 2004; 10: 7547-7554.
33. Dragnev KH, Ma T, Cyrus J, Galimberti F, Memoli V, Busch AM, Tsongalis GJ, Seltzer M, Johnstone D, Erkmen CP, Nugent W, Rigas JR, Liu X, Freemantle SJ, Kurie JM, Waxman S, Dmitrovsky E: Bexarotene plus erlotinib suppress lung carcinogenesis independent of KRAS mutations in two clinical trials and transgenic models. Cancer Prev Res 2011; 4: 818-828.
34. Simon R, Freidlin B, Rubinstein L, Arbuck SG, Collins J, Christian MC: Accelerated titration designs for phase I clinical trials in oncology. J Natl Cancer Inst 1997; 89: 1138-1147.
35. Cancer Therapy Evaluation Program: Common Terminology Criteria for Adverse Events (v3.0). Bethesda, National Cancer Institute, 2003.
36. Therasse P, Arbuck SG, Eisenhauer EA, 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 2000; 92: 205-216.
37. Hande KR, Wolff SN, Greco FA, Hainsworth JD, Reed G, Johnson DH: Etoposide kinetics in patients with obstructive jaundice. J Clin Oncol 1990; 8: 1101-1107.
38. Maurel J, Zorrilla M, Puertolas T, Anton A, Herrero A, Artal A, Alonso V, Martinez-Trufero J, Puertas MM: Phase I trial of weekly gemcitabine at 3-h infusion in refractory, heavily pretreated advanced solid tumors. Anticancer Drugs 2001; 12: 713-717.
39. Oguri S, Sakakibara T, Mase H, Shimizu T, Ishikawa K, Kimura K, Smyth RD: Clinical pharmacokinetics of carboplatin. J Clin Pharmacol 1988; 28: 208-215.
40. Mauer AM, Cohen EE, Ma PC, Kozloff MF, Schwartzberg L, Coates AI, Qian J, Hagey AE, Gordon GB: A phase II study of ABT-751 in patients with advanced non-small cell lung cancer. J Thorac Oncol 2008; 3: 631-636.
41. Rudin CM, Mauer A, Smakal M, Juergens R, Spelda S, Wertheim M, Coates A, McKeegan E, Ansell P, Zhou X, Qian J, Pradhan R, Dowell B, Krivoshik A, Gordon G: Phase I/II study of pemetrexed with or without ABT-751 in advanced or metastatic non-small-cell lung cancer. J Clin Oncol 2011; 29: 1075-1082.
42. White SC, Lorigan P, Middleton MR, Anderson H, Valle J, Summers Y, Burt PA, Arance A, Stout R, Thatcher N: Randomized phase II study of cyclophosphamide, doxorubicin, and vincristine compared with single-agent carboplatin in patients with poor prognosis small cell lung carcinoma. Cancer 2001; 92: 601-608.
43. Sandler A, Gray R, Perry MC, Brahmer J, Schiller JH, Dowlati A, Lilenbaum R, Johnson DH: Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med 2006; 355: 2542-2550.