Phase I drug-interaction study of effects of calcium and magnesium infusions on oxaliplatin pharmacokinetics and acute neurotoxicity in colorectal cancer patients

BMC Cancer

Volumn 13, Issue , 2013, Pages

  Han, Catherine H ^a,b   Khwaounjoo, Prashannata ^a   Kilfoyle, Dean H ^b   Hill, Andrew ^a,b   McKeage, Mark J ^a,b  

^a UNIVERSITY OF AUCKLAND   (New Zealand)

^b AUCKLAND CITY HOSPITAL   (New Zealand)

Author keywords

Acute neuropathy; Calcium and magnesium; Colorectal cancer; Hyperexcitability; Neurotoxicity; Oxaliplatin; Pharmacokinetics

Indexed keywords

CAPECITABINE; FLUOROURACIL; FOLINIC ACID; GLUCONATE CALCIUM; MAGNESIUM SULFATE; OXALIPLATIN; PLACEBO; PLATINUM DERIVATIVE;

ACUTE TOXICITY; ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; CANCER PATIENT; CANCER STAGING; CLINICAL ARTICLE; COLORECTAL CANCER; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE COMPARISON; DRUG DOSE REDUCTION; DRUG INFUSION; DRUG POTENTIATION; ELECTROMYOGRAPHY; FEMALE; HUMAN; MALE; MAXIMUM PLASMA CONCENTRATION; MEAN RESIDENCE TIME; MOTOR UNIT POTENTIAL; MULTIPLE CYCLE TREATMENT; MUSCLE CRAMP; NERVE EXCITABILITY; NEUROTOXICITY; PHASE 1 CLINICAL TRIAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CALCIUM; COLORECTAL NEOPLASMS; CROSS-OVER STUDIES; DRUG INTERACTIONS; FEMALE; HUMANS; MAGNESIUM; MALE; MIDDLE AGED; NEOPLASM STAGING; ORGANOPLATINUM COMPOUNDS; PERIPHERAL NERVOUS SYSTEM DISEASES; TREATMENT OUTCOME;

EID: 84886214290     PISSN: None     EISSN: 14712407     Source Type: Journal    
DOI: 10.1186/1471-2407-13-495     Document Type: Article

References (25)

1. Andre T, Boni C, Navarro M, Tabernero J, Hickish T, Topham C, Bonetti A, Clingan P, Bridgewater J, Rivera F, de Gramont A. Improved overall survival with oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment in stage II or III colon cancer in the MOSAIC trial. J Clin Oncol 2009, 27:3109-3116. 10.1200/JCO.2008.20.6771, 19451431.
2. Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M, Groupe Tumeurs Digestives of U FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med 2011, 364:1817-1825. 10.1056/NEJMoa1011923, 21561347, Groupe Tumeurs Digestives of U.
3. Cunningham D, Starling N, Rao S, Iveson T, Nicolson M, Coxon F, Middleton G, Daniel F, Oates J, Norman AR, Upper Gastrointestinal Clinical Studies Group of the National Cancer Research Institute of the United K Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med 2008, 358:36-46. 10.1056/NEJMoa073149, 18172173, Upper Gastrointestinal Clinical Studies Group of the National Cancer Research Institute of the United K.
4. de Gramont A, Figer A, Seymour M, Homerin M, Hmissi A, Cassidy J, Boni C, Cortes-Funes H, Cervantes A, Freyer G, Papamichael D, Le Bail N, Louvet C, Hendler D, de Braud F, Wilson C, Morvan F, Bonetti A. Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol 2000, 18:2938-2947.
5. Haller DG, Tabernero J, Maroun J, de Braud F, Price T, Van Cutsem E, Hill M, Gilberg F, Rittweger K, Schmoll HJ. Capecitabine plus oxaliplatin compared with fluorouracil and folinic acid as adjuvant therapy for stage III colon cancer. J Clin Oncol 2011, 29:1465-1471. 10.1200/JCO.2010.33.6297, 21383294.
6. Kuebler JP, Wieand HS, O'Connell MJ, Smith RE, Colangelo LH, Yothers G, Petrelli NJ, Findlay MP, Seay TE, Atkins JN, Zapas JL, Goodwin JW, Fehrenbacher L, Ramanathan RK, Conley BA, Flynn PJ, Soori G, Colman LK, Levine EA, Lanier KS, Wolmark N. Oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: results from NSABP C-07. J Clin Oncol 2007, 25:2198-2204. 10.1200/JCO.2006.08.2974, 17470851.
7. Rothenberg ML, Oza AM, Bigelow RH, Berlin JD, Marshall JL, Ramanathan RK, Hart LL, Gupta S, Garay CA, Burger BG, Le Bail N, Haller DG. Superiority of oxaliplatin and fluorouracil-leucovorin compared with either therapy alone in patients with progressive colorectal cancer after irinotecan and fluorouracil-leucovorin: interim results of a phase III trial. J Clin Oncol 2003, 21:2059-2069. 10.1200/JCO.2003.11.126, 12775730.
8. Yothers G, O'Connell MJ, Allegra CJ, Kuebler JP, Colangelo LH, Petrelli NJ, Wolmark N. Oxaliplatin as adjuvant therapy for colon cancer: updated results of NSABP C-07 trial, including survival and subset analyses. J Clin Oncol 2011, 29:3768-3774. 10.1200/JCO.2011.36.4539, 3188282, 21859995.
9. Grothey A. Oxaliplatin-safety profile: neurotoxicity. Semin Oncol 2003, 30:5-13.
10. Hill A, Bergin P, Hanning F, Thompson P, Findlay M, Damianovich D, McKeage MJ. Detecting acute neurotoxicity during platinum chemotherapy by neurophysiological assessment of motor nerve hyperexcitability. BMC Cancer 2010, 10:451. 10.1186/1471-2407-10-451, 2936328, 20731872.
11. Lehky TJ, Leonard GD, Wilson RH, Grem JL, Floeter MK. Oxaliplatin-induced neurotoxicity: acute hyperexcitability and chronic neuropathy. Muscle Nerve 2004, 29:387-392. 10.1002/mus.10559, 14981738.
12. Wilson RH, Lehky T, Thomas RR, Quinn MG, Floeter MK, Grem JL. Acute oxaliplatin-induced peripheral nerve hyperexcitability. J Clin Oncol 2002, 20:1767-1774. 10.1200/JCO.2002.07.056, 11919233.
13. Gamelin L, Boisdron-Celle M, Delva R, Guerin-Meyer V, Ifrah N, Morel A, Gamelin E. Prevention of oxaliplatin-related neurotoxicity by calcium and magnesium infusions: a retrospective study of 161 patients receiving oxaliplatin combined with 5-Fluorouracil and leucovorin for advanced colorectal cancer. Clin Cancer Res 2004, 10:4055-4061. 10.1158/1078-0432.CCR-03-0666, 15217938.
14. Grothey A, Nikcevich DA, Sloan JA, Kugler JW, Silberstein PT, Dentchev T, Wender DB, Novotny PJ, Chitaley U, Alberts SR, Loprinzi CL. Intravenous calcium and magnesium for oxaliplatin-induced sensory neurotoxicity in adjuvant colon cancer: NCCTG N04C7. J Clin Oncol 2011, 29:421-427. 10.1200/JCO.2010.31.5911, 3058288, 21189381.
15. Gamelin E, Gamelin L, Bossi L, Quasthoff S. Clinical aspects and molecular basis of oxaliplatin neurotoxicity: current management and development of preventive measures. Semin Oncol 2002, 29:21-33.
16. Khwaounjoo P. In vitro studies of the effect of calcium and magnesium on the stability of oxaliplatin in chloride solution/Prashannata Khwaounjoo 2011, University of Auckland: Thesis (MSc--Biomedical Science).
17. Ip V, McKeage MJ, Thompson P, Damianovich D, Findlay M, Liu JJ. Platinum-specific detection and quantification of oxaliplatin and Pt(R, R-diaminocyclohexane)Cl(2) in the blood plasma of colorectal cancer patients. J Anal At Spectrom 2008, 23:881-884.
18. U.S. Department of Health and Human Services Food and Drug Administration CfDEaRC Guidance for Indrustry: Bioanalytical Method Validation 2001, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070107.pdf, U.S. Department of Health and Human Services Food and Drug Administration CfDEaRC.
19. Zhang Y, Huo M, Zhou J, Xie S. PKSolver: an add-in program for pharmacokinetic and pharmacodynamic data analysis in Microsoft excel. Comput Methods Programs Biomed 2010, 99:306-314. 10.1016/j.cmpb.2010.01.007, 20176408.
20. U.S. Department of Health and Human Services Food and Drug Administration CfDEaRC Drug Interaction Studies -Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations 2012, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm292362.pdf, U.S. Department of Health and Human Services Food and Drug Administration CfDEaRC.
21. Shord SS, Bernard SA, Lindley C, Blodgett A, Mehta V, Churchel MA, Poole M, Pescatore SL, Luo FR, Chaney SG. Oxaliplatin biotransformation and pharmacokinetics: a pilot study to determine the possible relationship to neurotoxicity. Anticancer Res 2002, 22:2301-2309.
22. Ishibashi K, Okada N, Miyazaki T, Sano M, Ishida H. Effect of calcium and magnesium on neurotoxicity and blood platinum concentrations in patients receiving mFOLFOX6 therapy: a prospective randomized study. Int J Clin Oncol 2010, 15:82-87. 10.1007/s10147-009-0015-3, 20108160.
23. Chay WY, Tan SH, Lo YL, Ong SY, Ng HC, Gao F, Koo WH, Choo SP. Use of calcium and magnesium infusions in prevention of oxaliplatin induced sensory neuropathy. Asia Pac J Clin Oncol 2010, 6:270-277. 10.1111/j.1743-7563.2010.01344.x, 21114776.
24. Grothey AHL, Rowland KM, et al. Intermittent Oxaliplatin (oxali) administration and time-to-treatment-failure (TTF) in metastatic colorectal cancer (mCRC): final results of the phase III CONcePT trial. J Clin Oncol 2008, 26:4010.
25. Loprinzi CL, Qin R, Dakhil SR, Fehrenbacher L, Stella PJ, Atherton PJ, Seisler D, Qamar R, Lewis GC, Grothey A. Phase III randomized, placebo (PL)-controlled, double-blind study of intravenous calcium/magnesium (CaMg) to prevent oxaliplatin-induced sensory neurotoxicity (sNT), N08CB: an alliance for clinical trials in oncology study. J Clin Oncol 2013, 31(suppl):3501.