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Original Article

Phase I Study of Arabinosyl-5-zacytidine (Fazarabine) in Adult Acute Leukemia and Chronic Myelogenous Leukemia in Blastic Phase

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Pages 511-518 | Received 30 Dec 1998, Published online: 01 Jul 2009

References

  • Mayer R J. Current chemotherapeutic treatment approaches to the management of previously untreated adults with de novo acute myelogenous leukemia. Sem Oncol 1987; 14: 384–96
  • Mayer R J, Davis R B, Schiffer C A, et al. Intensive post‐remission chemotherapy in adults with acute myeloid leukemia. N Engl J Med 1994; 331: 896–903
  • Beisler J A, Abbasi M M, Driscoll J S. The synthesis and anti‐tumor activity of arabinosyl‐5 azacytosine. Biochem Pharmacol 1977; 26: 2469–72
  • Driscoll J S. The preclinical new drug research program of the National Cancer Institute. Cancer Treat Rep 1984; 68: 63–76
  • Townsend A, Leclerc J M, Dutschman G, Cooney D A, Cheng Y C. Metabolism of 1–β‐D arabinosyl‐5‐zacytosine and incorporation into DNA of human T‐lymphoblastic cells (Molt‐4). Cancer Res 1985; 45: 3522–8
  • Glaser R I, Knode M C. l‐β‐D‐arabinosyl‐5‐zacytosine: cytocidal activity and effects on the synthesis and methyla‐tion of DNA in human colon carcinoma cells. Mol Pharmacol 1984; 26: 381–7
  • Veseiy J, Piskala A. Mechanism of action of I‐β‐D‐ara‐binofuranosyl‐5‐zacytosine and its effects in L 12 10 leukemia cells. Neoplasma 1986; 33: 3–10
  • Dalal M, Plowman J, Breitman T R, et al. Arabinofurano‐syl‐5‐zacytosine: antitumor and cytotoxic properties. Cancer Res 1986; 46: 831–8
  • Zaharko D S, Covey J M. Arabinosyl‐5‐zacytosine: plasma kinetics and therapeutic.response (L 1210) in vitro and in vivo in mice. Invest New Drugs 1985; 3: 323–9
  • Driscoll J S, Johns D G, Plowman J. Comparison of the activity of arabinosyl‐5‐zacytosine, arabinosyl cytosine, and 5‐zacytidine against intracellularly implanted L 1210 leukemia. Invest New Drugs 1985; 3: 3314
  • Grem J L, Shoemaker D D, Hoth D F, et al. Arabinosyl‐5‐za‐cytosine: a novel nucleoside entering clinical trials. Invest New Drugs 1987; 5: 315–32
  • Wallace R E, Lindh D, Durr F E. Arabinosyl‐5‐zacytosine (ara‐AC, fazarabine, NSC 281272) activity against human tumor xenografts. Proc Am Assoc Cancer Res 1987; 28: 307
  • Surbone A, Ford H, Kelley J A, et al. Phase I and pharmacok‐inetic study of arabinofuranosyl 5‐zacytosine (Fazarabine, NSC 281272). Cancer Res 1990; 50: 1220–5
  • Bennett J M, Catovsky D, Daniel M T, et al. Proposals for the classification of the acute leukemias. Br J Haematol 1976; 33: 451–8
  • National Cancer Institute. Guidelines for reporting of adverse drug reactions. Division of Cancer Treatment, National Cancer Institute, Bethesda, MD 1988
  • Notari R E, De Young J L. Kinetics and mechanisms of degradation of the antileukemic agent 5‐zacytidine in aqueous solutions. J Pharm Sci 1975; 64: 1148–56
  • Mojaverian P, Repta A J. Development of an intravenous formulation of the unstable investigational cytotoxic nucleo‐sides 5‐zacvtosine arabinoside and 5‐zacvtidine. J Pharm Pharmacol 1984; 36: 728–33
  • Estey E, Kornblau S, Pierce S, Kantarjian H, Beran M, Keating M. A stratification system for evaluating and selecting therapies in patients with relapsed or primary refractory acute myelogenous leukemia. Blood 1996; 88: 756
  • Glazer R, Knode M. I‐β‐D‐Arabinosyl‐5‐acytosine. Cyto‐cidal activity and effects on the synthesis and methylation of DNA in human colon carcinoma cells. Mol Pharmacol 1984; 26: 381–7
  • Kantarjian H M, Estey E H, Keating M A. New chemothera‐peutic agents in acute myeloid leukemia. Leukemia 1996; 10(Suppl 1)4–6
  • Attadia V. Effects of 5‐za‐2‐eoxycytidine on differentiation and oncogen expression in the human monoblastic leukemia cell line U‐937. Leukemia 1993; 7(Suppl 1)9–16
  • Moore M, Andersen J, Bums H. A randomized trial of gem‐citabine versus 5‐U as first‐line therapy in advanced pancreatic cancer. Proc Am Soc Clin 1995; 14: 199, abstr
  • Anderson F L, Lund B, Hansen H H, et al. Phase 11 study of gemcitabine in non‐small cell lung cancer. Proc Am Soc Clin Oncol 1991; 10: 247, abstr
  • Smith T L, Lee J, Kantarjian H M, Legha S S, Raber M N. Design and results of phase I cancer clinical trials: three‐year experience at M. D. Anderson Cancer Center. J Clin Oncol 1996; 14: 287–295
  • Estey E, Hoth D, Simon R, et al. Therapeutic response in phase I trials of antineoplastic agents. Cancer Treat Rep 1986; 70: 1105–1115
  • Penta J S, Rosner G L, Trump D L. Choice of starting dose and escalation for phase I studies of antitumor agents. Cancer Chemother Pharmacol 1992; 31: 247–250
  • Von Hoff D D, Turner J. Response rates, duration of response, and dose response effects in phase I studies of antineoplas‐tics. Invest New Drugs 1991; 9: 115–122
  • O'Quigley J, Pepe M, Fisher L. Continual reassessment method A practical design for phase I clinical trials in cancer. Biometrics 1990; 46: 33–48
  • Gatsonis C, Greenhouse J B. Bayesian methods for phase I clinical trials. StatMed 1992; 1: 1377–1389
  • Mick R, Lane N, Daugherty C, et al. Physician‐determined patient risk of toxic effects: impact on enrollment and decision making in phase I cancer trials. J Natl Cancer Inst 1994; 86: 1685–1693
  • O'Quigley J. Estimating the probability of toxicity at the recommended dose following a phase I clinical trial in cancer. Biometrics 1992; 48: 853–862
  • Chevret S. The continual reassessment method in cancer phase I clinical trials: A simulation study. Stat Med 1993; 12: 1093–1108
  • Goodman S N, Zahurak M, Piantadosi S. Some practical improvements in the continual reassessment method for phase I studies. Stat Med 1994; 13: 1–13
  • Collins J M, Grieshaber C K, Chabner B A. Pharmacologically guided phase I clinical trials based upon preclinical drug development. J Natl Cancer Inst 1990; 82: 1321–1326
  • Mick R, Ratain M J. Model‐guided determination of maximum tolerated dose in phase I clinical trials: Evidence for increased precision. J Natl Cancer Inst 1993; 85: 217–223

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