Phase I clinical and pharmacokinetic study of topotecan administered by a 24-hour continuous infusion.
作者： L J van Warmerdam , W W ten Bokkel Huinink , S Rodenhuis , I Koier , B E Davies
DOI: 10.1200/JCO.1995.13.7.1768
关键词: Pharmacology 、 Topotecan 、 Vomiting 、 Medicine 、 Nausea 、 Leukopenia 、 Camptothecin 、 Chemotherapy 、 Pharmacokinetics 、 Mucositis
摘要: PURPOSETo determine the maximum-tolerable dose (MTD) and to investigate pharmacokinetics pharmacodynamics of topotecan in a phase I study. Topotecan is novel semisynthetic derivative anticancer agent camptothecin inhibits intranuclear enzyme topoisomerase I. Broad preclinical activity rationalized further clinical evaluation.PATIENTS AND METHODSIn this trial, was administered by 24-hour continuous infusion every 21 days patients with solid malignant tumors.RESULTSA total 25 eligible patients, whom 22 were pretreated, entered They received following dosages topotecan: 2.5, 3.75, 5.60, 8.4, 10.5 mg/m2 infusion. Reversible leukopenia thrombocytopenia dose-limiting, mild anemia occurring regularly. Other toxicities, such as alopecia, mucositis, nausea, vomiting sporadic mild. Responses not observed. However, eight had stable disease. The plasma concentration-time curves compat...
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