TY - JOUR
T1 - Gemcitabine in patients with solid tumors and renal impairment
T2 - A pharmacokinetic phase I study
AU - Delaloge, Suzette
AU - Llombart, Antonio
AU - Di Palma, Mario
AU - Tourani, Jean Marc
AU - Turpin, Francois
AU - Ni, Lan
AU - Forgue, S. T.
AU - Le Chevalier, Thierry
PY - 2004/6/1
Y1 - 2004/6/1
N2 - The purpose of this phase I study was to determine the pharmacokinetics and toxicity of gemcitabine in patients with advanced, recurrent, and/or metastatic cancer and renal impairment. Patients were entered in 4 groups estimated by EDTA-Cr51 plasma clearance (CLp, mL/min): ≥80; ≥60 and <80; ≥30 and <60; and ≥30 and <80 plus renal insufficiency induced by previous chemotherapy, respectively. Gemcitabine 500 to 1000 mg/m2 was administered intravenously on days 1, 8, and 15 every 4 weeks. Plasma concentration data were pooled and analyzed using a population pharmacokinetic program (NONMEM). Eighteen white patients (14 females, 4 males) entered the study with a median age of 55 years. Linear regression analyses revealed no significant relationship between gemcitabine CLp and indices of renal impairment (EDTA-Cr51 CL; p = 0.797 or β2-microglobulin; p = 0.153). Hematologic and nonhematologic toxicities were mild. Thus, there seems to be no significant impact of mild to moderate renal insufficiency on gemcitabine pharmacokinetics in patients with advanced cancer.
AB - The purpose of this phase I study was to determine the pharmacokinetics and toxicity of gemcitabine in patients with advanced, recurrent, and/or metastatic cancer and renal impairment. Patients were entered in 4 groups estimated by EDTA-Cr51 plasma clearance (CLp, mL/min): ≥80; ≥60 and <80; ≥30 and <60; and ≥30 and <80 plus renal insufficiency induced by previous chemotherapy, respectively. Gemcitabine 500 to 1000 mg/m2 was administered intravenously on days 1, 8, and 15 every 4 weeks. Plasma concentration data were pooled and analyzed using a population pharmacokinetic program (NONMEM). Eighteen white patients (14 females, 4 males) entered the study with a median age of 55 years. Linear regression analyses revealed no significant relationship between gemcitabine CLp and indices of renal impairment (EDTA-Cr51 CL; p = 0.797 or β2-microglobulin; p = 0.153). Hematologic and nonhematologic toxicities were mild. Thus, there seems to be no significant impact of mild to moderate renal insufficiency on gemcitabine pharmacokinetics in patients with advanced cancer.
KW - Advanced cancer
KW - Gemcitabine
KW - Pharmacokinetics
KW - Renal impairment
KW - Solid tumors
UR - http://www.scopus.com/inward/record.url?scp=2942588389&partnerID=8YFLogxK
U2 - 10.1097/01.COC.0000071382.14174.C5
DO - 10.1097/01.COC.0000071382.14174.C5
M3 - Article
C2 - 15170150
AN - SCOPUS:2942588389
SN - 0277-3732
VL - 27
SP - 289
EP - 293
JO - American Journal of Clinical Oncology: Cancer Clinical Trials
JF - American Journal of Clinical Oncology: Cancer Clinical Trials
IS - 3
ER -