Oral cytarabine ocfosfate in acute myeloid leukemia and non-Hodgkin's lymphoma - Phase I/II studies and pharmacokinetics

Leukemia

Volumn 12, Issue 10, 1998, Pages 1618-1626

  Braess, J ^a   Freund, M ^b   Hanauske, A ^c   Heil, G ^d   Kaufmann, C ^a   Kern, W ^a   Schussler M ^e   Hiddemann, W ^a   Schleyer, E ^a  

^a UNIVERSITY OF GÖTTINGEN   (Germany)

^b UNIVERSITY OF ROSTOCK   (Germany)

^c UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^d HANNOVER MEDICAL SCHOOL   (Germany)

^e ASTA MEDICA AG   (Germany)

Author keywords

AML; Cytosine arabinoside; NHL; Oral application; Pharmacokinetics

Indexed keywords

CYTARABINE; CYTARABINE 5' STEARYLPHOSPHATE; PRODRUG; URACIL ARABINOSIDE;

ACUTE GRANULOCYTIC LEUKEMIA; AREA UNDER THE CURVE; ARTICLE; BLOOD TOXICITY; CLINICAL ARTICLE; CLINICAL TRIAL; DIARRHEA; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG HALF LIFE; DRUG METABOLISM; DRUG OXIDATION; DRUG UPTAKE; HUMAN; LEUKEMIA REMISSION; LIVER CELL; MAXIMUM PERMISSIBLE DOSE; NONHODGKIN LYMPHOMA; ORAL DRUG ADMINISTRATION; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SMALL INTESTINE ABSORPTION; THROMBOCYTOPENIA;

EID: 0031682978     PISSN: 08876924     EISSN: None     Source Type: Journal    
DOI: 10.1038/sj.leu.2401152     Document Type: Article

References (14)

1. Bishop JF, Matthews JP, Young GA, Szer J, Gillett A, Joshua D, Bradstock K, Enno A, Wolf MM, Fox R et al. A randomized study of high-dose cytarabine in induction in acute myeloid leukemia (see comments). Blood 1996; 87: 1710-1717.
2. Mayer RJ, Davis RB, Schiffer CA, Berg DT, Powell BL, Schulman P, Omura GA, Moore JO, McIntyre OR, Frei E III. Intensive postremission chemotherapy in adults with acute myeloid leukemia. Cancer and Leukemia Group B (see comments) New Engl J Med 1994; 331: 896-903.
3. Wiernik PH, Banks PL, Case DC Jr, Arlin ZA, Periman PO, Todd MB, Ritch PS, Enck RE, Weitberg AB. Cytarabine plus idarubicin or daunorubicin as induction and consolidaztion therapy for previously untreated adult patients with acute myeloid leukemia. Blood 1992; 79: 313-319.
4. Kern W, Schleyer E, Unterhalt M, Wormann B, Buchner T, Hiddemann W. High antileukemic activity of sequential high dose cytos-ine arabinoside and mitoxantrone in patients with refractory acute leukemias. Results of a clinical phase II study. Cancer 1997; 79: 59-68.
5. Breithaupt H, Pralle H, Eckhardt T, von Hattingberg M, Schick J, Loffler H. Clinical results and pharmacokinetics of high-dose cytosine arabinoside (HD ARA-C). Cancer 1982; 50: 1248-1257.
6. Capizzi RL, White JC, Powell BL, Perrino F. Effect of dose on the pharmacokinetic and pharmacodynamic effects of cytarabine. Semin Hematol 1991; 28: 54-69.
7. Saneyoshi M, Moruzumi M, Kodama K, Machida K, Kuminaka A, Yoshino H, Synthetic nucleosides and nucleotides. XVI. Synthesis and biological evaluation of a series of 1 -beta-D-arabinofuranosylcytosine-5′-alkyl or arylphosphates. Chemical Pharm Bull 1980; 28: 2915-2923.
8. Kodama K, Moruzumi M, Saitoh K, Kuninaka A, Yoshino A, Saneyoshi M. Antitumor activity and pharmacology of 1 -beta-D-arabinofuranosyl-5′-stearylphosphate: an orally active derivate of 1-beta-D-arabinofuranosylcytosine. Jpn J Cancer Res 1989; 80: 679-685.
9. Yoshida Y, Yamada Y, Watanabe T, Suga T, Takayama H. Participation of the peroxisomal beta-oxidation system in the chain shortening of PCA16, a metabolite of the cytosine arabinoside prodrug YNK01 in rat liver. Biochem Pharmacol 1990; 39: 1505-1512.
10. Schleyer E, Braess J, Ramsauer B, Unterhalt M, Kaufmann C, Wilde S, Schussler M, Hiddemann W. Pharmacokinetics of Ara-CMP-Stearate (YNK01): phase I study of the oral Ara-C derivative. Leukemia 1995; 9: 1085-1090.
11. Heinzel G, Bozler G, Van Rossum J (eds). Pharmacokinetics during Drug Development: Data Analysis and Evaluation Techniques. Curve Fitting Programs, 1982, pp. 207-208.
12. Tatsumi N, Yamada K, Ohshima T, Nakamura T, Ohno R, Masaoka T, Kimura I, Kimura K. Phase II study of YNK01 (1-beta-D-arabinofuranosylcytosine-5′-stearylphosphate) on hematological malignancies. Can To Kagaku Ryoho 1990; 17: 2387-2395.
13. Fukuoka M, Miyazaki T, Yoshida Y, Hattori M, Niitani H, Nakamura T, Hirota Y, Ohta K, Tanaka M, Suzuoki Y et al. Phase I study of YNK01 O-beta-D-arabinofuranosylcytosine-5′-stearylphosphate). Can To Kagaku Ryoho 1990; 17; 2213-2219.
14. Kiyama Y, Suzuki G, Masauzi N, Ohizumi H, Kobayashi N, Ogasawara M, Naohara T, Saito M, Higa T, Kasai M. Treatment of refractory hematologic malignancies by combination of cytarabine ocfosfate and etoposide. Can To Kagaku Ryoho 1996; 23: 1717-1720.