Clinical pharmacokinetic and in vitro combination studies of nolatrexed dihydrochloride (AG337, Thymitaq(TM)) and paclitaxel

British Journal of Cancer

Volumn 82, Issue 9, 2000, Pages 1519-1527

  Hughes, A N ^a,b   Griffin, M J ^a   Newell, D R ^a   Calvert, A H ^a,b   Johnston, A ^c   Kerr, B ^c   Lee, C ^c   Liang, B ^c   Boddy, A V ^a  

^a NEWCASTLE UNIVERSITY   (United Kingdom)

^b NEWCASTLE GENERAL HOSPITAL   (United Kingdom)

^c AGOURON PHARMACEUTICALS INC   (United States)

Author keywords

Inhibition; Interaction; Metabolism; Schedule

Indexed keywords

NOLATREXED; PACLITAXEL;

ADULT; AGED; ALOPECIA; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; BONE MARROW SUPPRESSION; CANCER; CANCER CELL CULTURE; CANCER COMBINATION CHEMOTHERAPY; CANCER INHIBITION; CLINICAL ARTICLE; CLINICAL TRIAL; DIARRHEA; DRUG BLOOD LEVEL; DRUG METABOLISM; DRUG POTENTIATION; FATIGUE; FEMALE; HEAD AND NECK CANCER; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN CELL; LIVER MICROSOME METABOLISM; MALE; MUCOSA INFLAMMATION; NEUROTOXICITY; PRIORITY JOURNAL; RASH; VOMITING;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; AREA UNDER CURVE; DRUG MONITORING; FEMALE; HEAD AND NECK NEOPLASMS; HUMANS; MALE; MIDDLE AGED; PACLITAXEL; QUINAZOLINES; TUMOR CELLS, CULTURED;

EID: 0034127610     PISSN: 00070920     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (40)

1. Aisner J and Cortes-Funes H (1997) Paclitaxel in head and neck and other cancers: future prospects. Semin Oncol 24: 113-115
2. Belani CP, Agarwala S, Johnson J, Cohn A, Bernstein J, Langer C, Jones V, White C, Loh K, Whiter D, Chew T, Johnston A and Clendeninn N (1997a) A phase II trial with Thymitaq™ (AG337) in patients with squamous cell carcinoma of the head and neck. Proc ASCO 16: 387a
3. Belani CP, Lembersky B, Ramanathan R, Cohn A, Loh K, Miller W, Green M, Chew T, Johnston A and Clendeninn N (1997b) A phase II trial of Thymitaq™ (AG337) in patients with adenocarcinoma of the colon. Proc ASCO 16: 272a
4. Berg SL, Tolcher A, O'Shaughnessy JA, Denicoll AM, Noone M, Ognibene FP, Cowan KH and Balis FM (1995) Effect of R-verapamil on the pharmacokinetics of paclitaxel in women with breast cancer. J Clin Oncol 13: 2039-2042
5. Chao Y, Chan WK, Birkhofer MJ, Hu OJ, Wang SS, Huang YS, Liu M, Whang-Peng J, Chi KH, Lui WY and Lee SD (1998) Phase II and pharmacokinetic study of paclitaxel therapy for unresectable hepatocellular carcinoma patients. Br J Cancer 78: 34-39
6. Chou TC and Talalay P (1984) Quantitative analysis of dose-effect relationships: the combined effects of multiple drugs or enzyme inhibitors. Adv Enzyme Reg 22: 27-55
7. Cresteil T, Monsarrat B, Alvinerie P, Treluyer JM, Vieira I and Wright M (1994) Taxol metabolism by human liver microsomes: identification of cytochrome P450 isozymes involved in its biotransformation. Cancer Res 54: 386-393
8. D'Andrea GM and Seidman AD (1997) Docetaxel and paclitaxel in breast cancer therapy: present status and future prospects. Semin Oncol 24: S1327-1344
9. Geoffroy F, Patel M, Ren Q-F and Grem J (1994) Interaction of fluorouracil and paclitaxel in MCF-7 human breast cancer. Proc AACR 35: 330 (abstract 1962)
10. Gianni L, Kearns C, Giani A, Capri G, Vigano L, Locatelli A, Bonadonna G and Egorin M (1995) Non-linear pharmacokinetic and metabolism of paclitaxel and its pharmacokinetic/pharmacodynamic relationships in humans. J Clin Oncol 13: 180-190
11. Gianni L, Vigano L, Locatelli A, Capri G, Giani A, Tarenzi E and Bonadonna G (1997) Human pharmacokinetic characterization and in vitro study of the interaction between doxorubicin and paclitaxel in patients with breast cancer. J Clin Oncol 15: 1906-1915
12. Goldspiel BR (1997) Clinical overview of the taxanes. Pharmacotherapy 17: 110-125
13. Harris JW, Rahman A, Kim B-R, Guengerich FP and Collins JM (1994) Metabolism of Taxol by human hepatic microsomes and liver slices: Participation of cytochrome P450 3A4 and an unknown P450 enzyme. Cancer Res 54: 4026-4035
14. Huizing MT, Keung ACF, Rosing H, van der Kuij V, ten Bokkel-Huinink WW, Mandjes IM, Dubbelman ARC, Pinedo HM and Beijnen JH (1993) Pharmacokinetics of paclitaxel and metabolism in a randomised comparative sludy in platinum-pretreated ovarian cancer patients. J Clin Oncol 11: 2127-2135
15. Jamis-Dow CA, Klecker RW, Katki AG and Collins JM (1995) Metabolism of taxol hy human and rat liver in vitro: A screen for drug interactions and interspecies differences. Cancer Chemother Pharmacol 36: 107-114
16. Jamis-Dow CA, Pearl ML, Watkins PB, Blake DS, Klecker RW and Collins JM (1997) Predicting drug interactions in vivo from experiments in vitro - Human studies with paclitaxel and ketoconazole. Am J Clin Oncol - Cancer Clin Trials 20: 592-599
17. Kano Y, Akutsu M, Tsunoda S, Mori K, Suzuki K and Adachi KI (1998) In vitro schedule-dependent interaction between paclitaxel and SN-38 (the active metabolite of irinotecan) in human carcinoma cell lines. Cancer Chemother Pharmacol 42: 91-98
18. Kearns CM (1997) Pharmacokinetics of the taxanes. Pharmacotherapy 17: 105S-109S
19. Kennedy MJ, Zahurak ML, Donehower RC, Noe D, Grochow LB, Sartorius S, Chen T-L, Bowling K, Duerr M and Rowinsky EK (1998) Sequence-dependent hematological toxicity associated with the 3-hour paclitaxel/cyclophosphamide doublet. Clin Cancer Res 4: 349-356
20. Keung ACF, Kaul S, Pinedo HM, ten Bokkel Huinink WW and Beijnen JH (1993) Pharmacokinetics of taxol given by 3-h or 24-h infusion to patients with ovarian carcinoma. Proc ASCO 12: 130 (abstract 321)
21. Kuhn J, Rizzo J, Chang S, Schold C, Spence A, Berger M, Robins H, Mehta M, Bozik M, Fulton D, Rector D and Prados M (1997) Effects of anticonvulsants on the pharmacokinetics and metabolic profile of paclitaxel. Proc ASCO 16: 224 (abstract 787)
22. Lillibridge JH, Liang BH, Kerr BM, Webber S, Quart B, Shells BV and Lee CA (1998) Characterization of the selectivity and mechanism of human cytochrome P450 inhibition by the human immunodeficiency virus protease inhibitor nelfinavir mesylate. Drug Metab Disp 26: 609-161
23. Loh K, Stuart K, Cohn A, White C, Hines J, Miller W, Green MR, Chew T, Johnston A and Clendeninn N (1997) A Phase II trial of Thymitaq™ (AG337) in patients with adenocarcinoma of the pancreas. Proc ASCO 16: 265a
24. Panday VR, Huizing MT, Willemse PH, De Graeff A, ten Bokkol Huinink WW, Vermorken JB and Beijnen JH (1997) Hepatic metabolism of paclitaxel and its impact in patients with altered hepatic function. Semin Oncol 24: S11-S38
25. Rafi I, Taylor GA, Calvete JA, Boddy AV, Balmanno K, Bailey N, Lind M, Calvert AH, Webber S, Jackson RC, Johnston AJ, Clendeninn N and Newell DR (1995) Clinical pharmacokinetic and pharmacodynamic studies with the nonclassical antifolate thymidylate synthase inhibitor 3,4-dihydro-2-amino-6-methyl-4-oxo-5-(4-pyridylthio)-quinazolone dihydrochloride (AG337) given by 24-hour continuous intravenous infusion. Clin Cancer Res 1: 1275-1284
26. Rafi I, Boddy AV, Calvete JA, Taylor GA, Newell DR, Bailey NP, Lind MJ, Green M, Hines J, Johnstone A, Clendeninn N and Calvert AH (1998) Preclinical and phase I clinical studies with the nonclassical antifolate thymidylate synthase inhibitor nolatrexed dihydrochloride given by prolonged administration in patients with solid tumors. J Clin Oncol 16: 1131-1141
27. Rowinsky EK (1997) Paclitaxel: dosing and schedule issues. Oncology 11: 7-19
28. Rowinskj EK, Gilbert MR, McGuire WP, Noe DA, Grochow LB, Forastiere AA, Ettinger DS, Lubejko BG, Clark B, Sartorius SE, Cornblath DR, Hendricks CB and Donehower RC (1991) Sequences of taxol and cisplatin: A phase I and pharmacologic study. J Clin Oncol 9: 1692-1703
29. Schlichenmyer WJ, Donehower RC, Chen TL, Bowling MK, McQuire WP and Rowinsky, EK (1995) Pre-treatment H2 receptor antagonists that differ in P450 modulation activity: comparative effects on paclitaxel clearance rates and neutropenia. Cancer Chemother Pharmacol 36: 227-232
30. Siddiqui N, Boddy AV, Thomas HD, Bailey NP, Robson L, Lind MJ and Calvert AH (1997) A clinical and pharmacokinetic study of the combination of carboplatin and paclitaxel for epithelial ovarian cancer. Br J Cancer 75: 287-294
31. Skehan P, Storeng R, Scudiero D, Monks A, McMahon J. Vistica D, Warren JY, Bokesch H, Kenney S and Boyd MR (1990) New colorimetric cylotoxicity assay for anticancer-drug screening. J Natl Cancer Inst 82: 1107-1112
32. Sonnichsen D and Relling M (1994) Clinical pharmacokinetics of paclitaxel. Clin Pharmacokin 27: 256-269
33. Sonnichsen DS, Liu Q, Schuetz EG, Schuetz JD, Pappo A and Relling MV (1995) Variability in human cytochrome P450 paclitaxel metabolism. J Pharmacol Exp Ther 275: 566-575
34. Stuart KE, Hajdenberg J, Cohn A, Loh KK, Miller W, White C and Clendeninn NJ (1996) A Phase II trial of Thymitaq™ (AG337) in patients with hepatocellular carcinoma. Proc ASCO 15: 202
35. Vanhoefer U, Harstrick A, Wilke H, Schleucher N, Walles H, Schroder J and Seeber S (1995) Schedule-dependent antagonism of paclitaxel and cisplatin in human gastric and ovarian carcinoma cell lines in vitro. Eur J Cancer 31A: 92-97
36. Venook AP, Egorin MJ, Rosner GL, Brown TD, Jahan TM, Batist G, Hohl R, Budman D, Ratain MJ, Kearns CM and Schilsky RL (1998) Phase I and pharmacokinotics trial of paclitaxel in patients with hepatic dysfunction. J Clin Oncol 16: 1811-1819
37. Vigano L, Lacatelli A, Bonadonna G and Egorin MJ (1995) Nonlinear pharmacokinetics and metabolism of paclitaxel and its pharmacokinetic/ pharmacodynamic relationships in humans. J Clin Oncol 13: 180-190
38. Vokes EE, Haraf DJ, Stenson K, Stupp R, Malone D, Levin J and Weichelsbaum RR (1995) The role of paclitaxel in the treatment of head and neck cancer. Semin Oncol 22 S12: 8-12
39. Webber SE, Bleckman TM, Attard J, Deal JG, Kathardekar V, Welsh KM, Webber S, Janson CA, Matthews DA, Smith WW, Freer ST, Jordan SR, Bacquet RJ, Howland, EF, Booth CLJ, Ward RW, Hermann SM, White J, Morse CA, Hilliard JA and Bartlett CA (1993) Design of thymidylate synthase inhibitors using protein crystal-structures - the synthesis and biological evaluation of a novel class of 5-substituted quinazolinones. J Med Chem 36: 733-746
40. Wilson WH, Berg SL, Bryant G, Wittes RE, Bates S, Fojo A, Steinberg SM, Goldspiel BR, Herdt J and O'Shaughnessy J (1994) Paclitaxel in doxorubicin-refractory or mitoxantrone-refractory breast cancer: a phase I/II trial of 96-hour infusion. J Clin Oncol 12: 1621-1629