Bioequivalence of two tablet formulations of capecitabine and exploration of age, gender, body surface area, and creatinine clearance as factors influencing systemic exposure in cancer patients

Cancer Chemotherapy and Pharmacology

Volumn 44, Issue 6, 1999, Pages 453-460

  Cassidy, Jim ^a   Twelves, Chris ^b   Cameron, David ^c   Steward, William ^d   O'Byrne, Ken ^d   Jodrell, Duncan ^c   Banken, Ludger ^e   Goggin, Timothy ^e   Jones, David ^g   Roos, Brigitte ^e   Bush, Ernie ^f   Weidekamm, Erhard ^e   Reigner, Bruno ^e  

^a ABERDEEN ROYAL INFIRMARY   (United Kingdom)

^b CRC Department of Medical Oncology   (United Kingdom)

^c WESTERN GENERAL HOSPITAL   (United Kingdom)

^d LEICESTER ROYAL INFIRMARY   (United Kingdom)

^e F HOFFMANN LA ROCHE LTD   (Switzerland)

^f HOFFMANN LA ROCHE INC   (United States)

^g ROCHE PRODUCTS LTD   (United Kingdom)

Author keywords

5 FU; Bioequivalence; Capecitabine; Pharmacokinetics

Indexed keywords

CAPECITABINE;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BODY SURFACE; CANCER PATIENT; CLINICAL ARTICLE; CLINICAL TRIAL; CREATININE CLEARANCE; CROSSOVER PROCEDURE; DRUG BIOAVAILABILITY; DRUG METABOLISM; FEMALE; HUMAN; HUMAN CELL; HUMAN TISSUE; MALE; ORAL DRUG ADMINISTRATION; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; SOLID TUMOR; TABLET FORMULATION; URINARY EXCRETION;

ANALYSIS OF VARIANCE; ANTINEOPLASTIC AGENTS; AREA UNDER CURVE; BIOTRANSFORMATION; BODY SURFACE AREA; CONFIDENCE INTERVALS; CREATININE; CROSS-OVER STUDIES; DEOXYCYTIDINE; FEMALE; HALF-LIFE; HUMANS; MALE; METABOLIC CLEARANCE RATE; NEOPLASMS; REGRESSION ANALYSIS; SEX CHARACTERISTICS; TABLETS; THERAPEUTIC EQUIVALENCY;

EID: 0032729847     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s002800051118     Document Type: Article

References (19)

1. 1. Miwa M, Ura M, Nishida M, Sawada N, Ishikawa T, Mori K, Shimma N, Umeda I, Ishitsuka H (1998) Design of a novel oral fluoropyrimidine carbamate, capecitabine, which generates 5-fluorouracil selectively in tumors by enzymes concentrated in human liver and cancer tissue. Eur J Cancer 34: 1274
2. 2. Takebayashi Y, Akiyama S, Akiba S, Yamada K, Miuadera K, Sumizawa T, Yamada Y, Murata F, Aikou T (1996) Clinicopathologic and prognostic significance of an angiogenic factor, thymidine phosphorylase, in human colorectal carcinoma. J Natl Cancer Inst 88: 1110
3. 3. Findlay M, Van Cutsem E, Kocha W, Allman D, Laffranchi B, Griffin T, Osterwalder B, Dalley D, Pazdur R, Verweij J (1997) A randomized phase II study of Xeloda™ (capecitabine) in patients with advanced colorectal cancer (abstract no. 798). Proc Am Soc Clin Oncol 16: 227a
4. 4. Blum JL, Budzur AU, Lo Russo PM, Kuter I, Vogel C, Burger HU, Brown C, Griffin TA (1998) A multicenter phase II trial of Xeloda™ (capecitabine) in Paclitaxel-refractory metastatic breast cancer (abstract no. 476). Proc Am Soc Clin Oncol 17: 125
5. 5. Mackean MJ, Th Planting AS, Twelves C, Schellens JHM, Allman D, Osterwalder B, Reigner B, Griffin T, Kayes SB, Verweij J (1998) A Phase I and pharmacologic study of intermittent twice daily oral therapy with capecitabine in patients with advanced and/or metastatic cancer. J Clin Oncol 16: 2977
6. 6. Du Bois D, Du Bois EF (1916) A formula to estimate the approximate surface area if height and weight be known. Arch Intern Med 17: 863
7. 7. Cockcroft DW, Gault MH (1976) Prediction of creatinine clearance from serum creatinine. Nephron 16: 31
8. 8. Reigner B, Clive S, Cassidy J, Jodrell D, Schulz R, Goggin T, Banken L, Roos B, Utoh M, Mulligan T, Weidekamm E (1998) Influence of the antacid Maalox® on the pharmacokinetics of capecitabine in cancer patients. Cancer Chemother Pharmacol (in press)
9. 9. Gibaldi M, Perrier D (1992) Pharmacokinetics, 2nd edn. Marcel Dekker, New York
10. 10. Committee for Proprietary Medicinal Products Guideline (final version) (1996) Investigation of bioavailability and bioequivalence, vol III, part 2. European Community, London
11. 11. SAS Institute (1993) SAS Companion for the Microsoft Windows Environment, Version 6, 1st edn. SAS Institute, Cary, NC
12. 12. Budman DR, Meropol NJ, Reigner B, Creavan PJ, Lichtman SM, Berghorn E, Behr J, Gordon RJ, Osterwalder B, Griffin T (1998) Preliminary studies of a novel oral fluoropyrimidine carbamate: capecitabine. J Clin Oncol 16: 1795
13. 13. Inaba M, Mitsuhashi J, Ozawa S (1990) Kinetic analysis of 5-fluorouracil action against various cancer cells. Jpn J Cancer Res 81: 1039
14. 14. Moore MJ, Theissen JJ (1992) Cytotoxics and irreversible effects. In: Boxtel CJ, Holford NHG, Danhof M (eds) The in vivo study of drug action. Elsevier Science, Amsterdam, p. 377
15. 15. Reigner B, Verweij J, Dirix L, Cassidy J, Twelves C, Allman D, Weidekamm E, Roos B, Banken L, Utoh M, Osterwalder B (1998) Effect of food on the pharmacokinetics of capecitabine and its metabolites following oral administration in cancer patients. Clin Cancer Res 4: 941
16. 16. Grochow LB (1990) Is dose normalization to weight or body surface area useful in adults? J Natl Cancer Inst 82: 323
17. 17. Ratain MJ (1998) Body surface area as a basis for dosing of anticancer agents: science, myth, or habit? J Clin Oncol 16: 2297
18. 18. Port RE, Daniel B, Ding RW, Hermann R (1991) Relative importance of dose, body surface area, sex and age for 5-fluorouracil clearance. Oncology 48: 277
19. 19. Reilly JJ, Workman P (1993) Normalisation of anti-cancer drug dosage using body weight and surface area: is it worthwhile? Cancer Chemother Pharmacol 32: 411