Intravesical administration of gemcitabine in superficial bladder cancer: A phase I study with pharmacodynamic evaluation

BJU International

Volumn 93, Issue 4, 2004, Pages 491-494

  De Berardinis, E ^a   Antonini, G ^a   Peters, G J ^b   Loves, W J P ^b   Van Der Born, K ^b   Codacci Pisanelli, G ^a,c   Silverio, F D I ^a  

^a SAPIENZA UNIVERSITY OF ROME   (Italy)

^b VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^c NONE   (Italy)

Author keywords

Gemcitabine; Intravesical; Pharmacology; Superficial bladder cancer; Trial

Indexed keywords

2',2' DIFLUORODEOXYURIDINE; BCG VACCINE; DEAMINASE; DEOXYCYTIDINE PHOSPHATE DEAMINASE; DRUG METABOLITE; GEMCITABINE; UNCLASSIFIED DRUG;

ADULT; AGED; ANEMIA; ARTICLE; BLADDER CANCER; BLADDER WALL; BLOOD TOXICITY; CANCER CHEMOTHERAPY; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG METABOLISM; DRUG SCREENING; DYSURIA; ENZYME ACTIVITY; ENZYME ASSAY; FEMALE; FLU LIKE SYNDROME; FOLLOW UP; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; LEUKOPENIA; LIVER TOXICITY; MALE; NEPHROTOXICITY; NEUTROPENIA; PHARMACODYNAMICS; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SKIN IRRITATION; SUPERFICIAL CANCER; SYSTEMIC DISEASE; THROMBOCYTOPENIA; URINARY FREQUENCY; URINARY URGENCY; DOSE RESPONSE; DRUG TOLERABILITY; DRUG TOXICITY;

ADMINISTRATION, INTRAVESICAL; AGED; ANTIMETABOLITES, ANTINEOPLASTIC; DEOXYCYTIDINE; DEOXYCYTIDINE KINASE; FEMALE; HUMANS; MALE; MIDDLE AGED; URINARY BLADDER NEOPLASMS;

EID: 1642328986     PISSN: 14644096     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1464-410X.2003.04656.x     Document Type: Article

References (21)

1. Cohen SM, Johansson SL. Epidemiology and etiology of bladder cancer. Urol Clin North Am 1992; 19: 421-8
2. Chopin DK, Gattegno B. Superficial bladder tumors. Eur Urol 2002; 42: 533-41
3. van der Meijden AP. Bladder cancer. BMJ 1998; 317: 1366-9
4. Au JL, Badalament RA, Wientjes MG et al. Methods to improve efficacy of intravesical mitomycin C: results of a randomized phase III trial. J Natl Cancer Inst 2001; 93: 597-604
5. Durek C, Richter E, Basteck A et al. The fate of bacillus Calmette-Guerin after intravesical instillation. J Urol 2000; 165: 1765-8
6. Sandler AB, Nemunaitis J, Denham C et al. Phase III trial of gemcitabine plus cisplatin versus cisplatin alone in patients with locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol 2000; 18: 122-30
7. Burris HA 3rd, Moore MJ, Andersen J et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol 1997; 15: 2403-13
8. Carmichael J. The role of gemcitabine in the treatment of other tumours. Br J Cancer 1998; 78 (Suppl. 3): 21-5
9. Von der Maase H, Hansen SW, Roberts JT. Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: results of a large, randomized, multinational, multicenter, phase III study. J Clin Oncol 2000; 18: 3068-77
10. Cozzi PJ, Bajorin DF, Tong W et al. Toxicology and pharmacokinetics of intravesical gemcitabine: a preclinical study in dogs. Clin Cancer Res 1999; 5: 2629-37
11. Dalbagni G, Russo P, Sheinfeld J et al. Phase I trial of intravesical gemcitabine in bacillus Calmette-Guérin-refractory transitional-cell carcinoma of the bladder. J Clin Oncol 2002; 20: 3193-8
12. Laufer M, Ramalingam S, Schoenberg MP et al. Intravesical gemcitabine therapy for superficial transitional cell carcinoma of the bladder: a phase I and pharmacokinetic study. J Clin Oncol 2003; 21: 697-703
13. Kroep JR, Giaccone G, Voorn DA et al. Gemcitabine and paclitaxel: pharmacokinetic and pharmacodynamic interactions in patients with non-small-cell lung cancer. J Clin Oncol 1999; 17: 2190-7
14. Kroep JR, Loves WJP, van der Wilt CL et al. Pretreatment deoxycytidine kinase levels predict in vivo gemcitabine sensitivity. Mol Cancer Ther 2002; 1: 371-6
15. Peters GJ, Laurensse EJ, Leyva A, Pinedo HM. Tissue homogenization using a micro-dismembrator for the measurement of enzyme activities. Clin Chim Acta 1986; 158: 193-8
16. Bergman AM, Pinedo HM, Jongsma AP et al. Decreased resistance to gemcitabine (2′,2′-difluorodeoxycytidine) of cytosine arabinoside-resistant myeloblastic murine and rat leukemia cell lines: role of altered activity and substrate specificity of deoxycytidine kinase. Biochem Pharmacol 1999; 57: 397-406
17. Rots MG, Willey JC, Jansen G et al. mRNA expression levels of methotrexate resistance-related proteins in childhood leukemia as determined by a standardized competitive template-based RT-PCR method. Leukemia 2000; 14: 2166-75
18. Van der Wilt CL, Kroep JR, Loves WJP et al. Expression of deoxycytidine kinase measured in leukemic cells in comparison to solid tumor cell lines is applicable for small samples of liver metastases and normal liver. Eur J Cancer 2003; 39: 691-7
19. Moore MJ, Tannock IF, Ernst DS, Huan S, Murray N. Gemcitabine: a promising new agent in the treatment of advanced urothelial cancer. J Clin Oncol 1997; 15: 3441-5
20. Paroni R, Salonia A, Lev A et al. Effect of local hyperthermia of the bladder on mitomycin C pharmacokinetics during intravesical chemotherapy for the treatment of superficial transitional cell carcinoma. Br J Clin Pharmacol 2001; 52: 273-8
21. De Bruijn EA, Sleeboom HP, van Helsdingen PJ, van Oosterum AT, Tjaden UR, Maes RA. Pharmacodynamics and pharmacokinetics of intravesical mitomycin C upon different dwelling times. Int J Cancer 1992; 51: 359-64