Document Detail

Phase I pharmacokinetic study of a single intravesical instillation of gemcitabine administered immediately after transurethral resection plus multiple random biopsies in patients with superficial bladder cancer.
MedLine Citation:
PMID:  15247710     Owner:  NLM     Status:  MEDLINE    
PURPOSE: In this phase I study we determined the pharmacokinetic and toxicity profiles of a single intravesical instillation of gemcitabine administered immediately after complete transurethral resection (TUR) plus multiple random biopsies.
MATERIALS AND METHODS: Ten patients with superficial bladder cancer clinically staged as Ta/T1 with no carcinoma in situ were included. A single dose of gemcitabine was administered intra-vesically immediately after TUR plus 6 random biopsies. Five patients received 1,500 mg and 5 received 2,000 mg diluted in 100 ml saline. Retention time in the bladder was 60 minutes. Concentrations of gemcitabine and dFdU (2',2'-difluoro-2'-deoxyuridine) were determined by high pressure liquid chromatography assay.
RESULTS: Treatment was clinically well tolerated in all patients. Two patients in the 1,500 mg group had minimal hipogastric discomfort and 1 in the 2,000 mg group had grade 1 bladder spasms. There was no remarkable systemic toxicity on hematology or biochemistry at any dose level on day 12 or 30. One patient per dose level showed tumor recurrence on 3-month repeat cystourethroscopy. Mean maximum gemcitabine concentration was 1.8 microg/ml and the mean last AUC was 158 microg/ml*minute. There was large interpatient variability but no significant differences between the 2 dose levels.
CONCLUSIONS: Single intravesical instillation of gemcitabine immediately after TUR and multiple random biopsies for superficial bladder cancer are a safe and well tolerated treatment. The favorable toxicity and pharmacokinetic profiles of intravesical gemcitabine support future phase II studies with this agent.
Juan Palou; Antonio Carcas; Jose Segarra; Blanca Duque; Jose Salvador; Ignacio Garcia-Ribas; Humberto Villavicencio
Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase I; Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The Journal of urology     Volume:  172     ISSN:  0022-5347     ISO Abbreviation:  J. Urol.     Publication Date:  2004 Aug 
Date Detail:
Created Date:  2004-07-12     Completed Date:  2004-08-09     Revised Date:  2013-06-03    
Medline Journal Info:
Nlm Unique ID:  0376374     Medline TA:  J Urol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  485-8     Citation Subset:  AIM; IM    
Department of Urology Fundació Puigvert, Universidad Autónoma de Barcelona, Spain.
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MeSH Terms
Administration, Intravesical
Aged, 80 and over
Antimetabolites, Antineoplastic / administration & dosage,  pharmacokinetics*
Carcinoma, Transitional Cell / drug therapy*,  surgery
Deoxycytidine / administration & dosage,  analogs & derivatives*,  pharmacokinetics*
Middle Aged
Urinary Bladder Neoplasms / drug therapy*,  surgery
Reg. No./Substance:
0/Antimetabolites, Antineoplastic; 951-77-9/Deoxycytidine; B76N6SBZ8R/gemcitabine

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