Pharmacokinetics of oxaliplatin and non-hematological toxicity in metastatic gastrointestinal cancer patients treated with chronomodulated oxaliplatin, 5-FU and sodium folinate in a pilot investigation

International Journal of Clinical Pharmacology and Therapeutics

Volumn 44, Issue 3, 2006, Pages 128-134

  Merkel, Ute ^a   Farker, K ^a   Wedding, U ^a   Roskos, M ^a   Hippius, M ^a   Hoffken K ^a   Hoffmann, A ^a  

^a FRIEDRICH SCHILLER UNIVERSITY JENA   (Germany)

Author keywords

Modulated; Non hematological toxicity; Oxaliplatin chrono; Pharmacokinetics

Indexed keywords

FLUOROURACIL; FOLINIC ACID; OXALIPLATIN;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; BILIARY TRACT CANCER; CANCER PATIENT; CARDIA CARCINOMA; CHRONOPHARMACOLOGY; CLINICAL ARTICLE; COLORECTAL CANCER; CONTROLLED STUDY; DIARRHEA; DIGESTIVE SYSTEM CANCER; DISEASE ASSOCIATION; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG CLEARANCE; FEMALE; FEVER; HUMAN; INFECTION; LIVER METASTASIS; LUNG METASTASIS; LYMPH NODE METASTASIS; MALE; METASTASIS POTENTIAL; MOOD DISORDER; MOTOR NEUROPATHY; MUCOSA INFLAMMATION; NAUSEA AND VOMITING; NEUROLOGIC DISEASE; PANCREAS CANCER; PILOT STUDY; PREDICTION; RISK ASSESSMENT; SAMPLE SIZE; SENSORY NEUROPATHY; STOMATITIS;

EID: 33644761706     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/cpp44128     Document Type: Article

References (29)

1. Advanced Colorectal Cancer Meta-Analysis Project. Modulation of fluorouracil by leucovorin in patients with advanced colorectal cancer: evidence in terms of response rate. J Clin Oncol. 1992; 10: 896-903.
2. Bruguerolle B. Chronopharmacokinetics. Clin Pharmacokinet. 1998; 35: 83-94.
3. Culy CR, Clemett D, Wiseman LR. Oxaliplatin. A review of its pharmacological properties and clinical efficacy in metastatic colorectal cancer and its potential in other malignancies. Drugs. 2000; 60: 895-924.
4. Cvitkovic E, Bekradda M. Oxatiplatin: a new therapeutic option in colorectal cancer. Semin Oncol. 1999; 26: 647-662.
5. de Gramont A, Bosset JF, Milan C, Rougier P, Bouche O, Etienne PL, Morvan F, Louvet C, Guillot T, Francois E, Bedenne L. Randomized trial comparing monthly low-dose leucovorin and fluorouracil bolus with bimonthly high-dose leucovorin and fluorouracil bolus plus continuous infusion for advanced colorectal cancer: a French intergroup study. J Clin Oncol. 1997; 15: 808-815.
6. 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.
7. Delord JP, Umlil A, Guimbaud R, Gregoire N, Lafont T, Canal P, Bugat R, Chatelut E. Population pharmacokinetics of oxaliplatin. Cancer Chemother Pharmacol. 2003; 51: 127-131.
8. Douillard JY, Cunningham D, Roth AD, Navarro M, James RD, Karasek P, Jandik P, Iveson T, Carmichael J, Alakl M, Gruia G, Awad L, Rougier P. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet. 2000; 355: 1041-1047.
9. Falcone A, Masi G, Allegrini G, Danesi R, Pfanner E, Brunetti IM, DiPaolo A, Cupini S, Del Tacca M, Conte P. Biweekly chemotherapy with oxaliplatin, irinotecan, infusional fluorouracil, and leucovorin: a pilot study in patients with metastatic colorectal cancer. J Clin Oncol. 2002; 20: 4006-4014.
10. Garufi C, Levi F, Aschelter AM, Pace R, Giunta S, Nistico C, Galla DA, Silecchia GF, Franchi F, Narduzzi C, Terzoli E. A phase I trial of 5-day chronomodulated infusion of 5-fluorouracil and 1-folinic acid in patients with metastatic colorectal cancer. Eur J Cancer. 1997; 33: 1566-1571.
11. Giacchetti S, Perpoint B, Zidani R, Le Bail N, Faggiuolo R, Focan C, Chollet P, Llory JF, Letourneau Y, Coudert B, Bertheaut-Cvitkovic F, Larregain-Fournier D, Le Rol A, Walter S, Adam R, Misset JL, Levi F. Phase III multicenter randomized trial of oxaliplatin added to chronomodulated fluorouracil-leucovorin as first-line treatment of metastatic colorectal cancer. J Clin Oncol. 2000; 18: 136-147.
12. Graham MA, Lockwood GF, Greenslade D, Brienza S, Bayssas M, Gamelin E. Clinical pharmacokinetics of oxaliplatin: a critical review. Clin Cancer Res. 2000; 6: 1205-1218.
13. Köhne CH, Wils J, Lorenz M, Schoffski P, Voigtmann R, Bokemeyer C, Lutz M, Kleeberg C, Ridwelski K, Souchon R, El-Serafi M, Weiss U, Burkhard O, Ruckle H, Lichnitser M, Langenbuch T, Scheithauer W, Baron B, Couvreur ML, Schmoll HJ; European Organization of Research and Treatment of Cancer Gastrointestinal Group Study 40952. Randomized phase III study of high-dose fluorouracil given as a weekly 24-hour infusion with or without leucovorin versus bolus fluorouracil plus leucovorin in advanced colorectal cancer: J Clin Oncol. 2003; 21: 3721-3728.
14. Levi F, Zidani R, Misset JL. Randomised multicentre trial of chronotherapy with oxaliplatin, fluorouracil, and folinic acid in metastatic colorectal cancer. International Organization for Cancer Chronotherapy. Lancet. 1997; 350: 681-686.
15. Levi F, Zidani R, Brienza S, Dogliotti L, Perpoint B, Rotarski M, Letourneau Y, Llory JF, Chollet P, Le Rol A, Focan C. A multicenter evaluation of intensified, ambulatory, chronomodulated chemotherapy with oxaliplatin, 5-fluorouracil, and leucovorin as initial treatment of patients with metastatic colorectal carcinoma. International Organization for Cancer Chronotherapy. Cancer. 1999; 85: 2532-2540.
16. Levi F. Circadian chronotherapy for human cancers. Lancet Oncol. 2001; 2: 307-315.
17. Levi F, Metzger G, Massari C, Milano G. Oxaliplatin: pharmacokinetics and chronopharmacological aspects. Clin Pharmacokinet. 2000; 38: 1-21.
18. Lokich J. Infusional 5-FU: historical evolution, rationale, and clinical experience. Oncology. 1998; 12: 19-22.
19. Massari C, Brienza S, Rotarski M, Gastiaburu J, Misset JL, Cupissol D, Alafaci E, Dutertre-Catella H, Bastian G. Pharmacokinetics of oxaliplatin in patients with normal versus impaired renal function. Cancer Chemother Pharmacol. 2000; 45: 157-164.
20. Merkel U, Wedding U, Roskos M, Hofften K, Hoffmann A. Pharmacokinetics of oxaliplatin during chronomodulated infusion in metastatic gastrointestinal cancer patients: a pilot investigation with preliminary results. Exp Toxicol Pathol. 2003; 54: 475-479.
21. Meta-Analysis Group in Cancer. Efficacy of intravenous continuous infusion of fluorouracil compared with bolus administration in advanced colorectal cancer. J Clin Oncol. 1998; 16: 301-308.
22. Ohdo S. Changes in toxicity and effectiveness with timing of drug administration: implications for drug safety. Drug Saf. 2003; 26: 999-1010.
23. Raymond E, Buquet-Fagot C, Djelloul S, Mester J, Cvitkovic E, Allain P, Louver C, Gespach C. Antitumor activity of oxaliplatin in combination with 5-fluorouracil and the thymidylate synthase inhibitor AG337 in human colon, breast and ovarian cancers. Anticancer Drugs. 1997; 8: 876-885.
24. Rixe O, Ortuzar W, Alvarez M, Parker R, Reed E, Paull K, Fojo T. Oxaliplatin, tetraplatin, cisplatin, and carboplatin: spectrum of activity in drug-resistant cell lines and in the cell lines of the National Cancer Institute's Anticancer Drug Screen panel. Biochem Pharmacol. 1996; 52: 1855-1865.
25. Saltz LB, Cox JV, Blanke C, Rosen LS, Fehrenbacher L, Moore MJ, Maroun JA, Ackland SP, Locker PK, Pirotta N, Elfring GL, Miller LL. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group. N Engl J Med. 2000; 343: 905-914.
26. Sanofi-Synthelabo. Eloxatin® Prescription Information [online]. http://www.sanofi-synthelabo.us; 2004.
27. Simpson D, Dunn C, Curran M, Goa KL. Oxaliplatin: a review of its use in combination therapy for advanced metastatic colorectal cancer. Drugs. 2003; 63: 2127-2156.
28. Takimoto CH, Remick SC, Sharma S, Mani S, Ramanathan RK, Doroshow J, Hamilton A, Mulkerin D, Graham M, Lockwood GF, Ivy P, Egorin M, Schuler B, Greenslade D, Goetz A, Knight R, Thomas R, Monahan BP, Dahut W, Grem JL; National Cancer Institute Organ Dysfunction Working Group Study. Dose-escalating and pharmacological study of oxaliplatin in adult cancer patients with impaired renal function. J Clin Oncol. 2003; 21: 2664-2672.
29. Winnefeld K, Schröter H. Bestimmung des Platins im Serum mittels Graphitrohr-AAS 4. Applikations-schriften zur AAS, Zeiss Jena, Germany; 1992.