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

Journal of Urology

Volumn 172, Issue 2, 2004, Pages 485-488

  Palou, Juan ^a,d   Carcas, Antonio ^b   Segarra, Jose ^a   Duque, Blanca ^b   Salvador, Jose ^a   Garcia Ribas, Ignacio ^c   Villavicencio, Humberto ^a  

^a UNIVERSITAT AUTÒNOMA DE BARCELONA   (Spain)

^b HOSPITAL UNIVERSITARIO LA PAZ   (Spain)

^c ELI LILLY AND COMPANY   (Spain)

^d FUNDACIÓ PUIGVERT   (Spain)

Author keywords

Administration, intravesical; Bladder; Bladder neoplasms; Gemcitabine

Indexed keywords

ANTINEOPLASTIC AGENT; GEMCITABINE;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; BLADDER BIOPSY; BLADDER CANCER; BLADDER SPASM; CANCER CHEMOTHERAPY; CLINICAL ARTICLE; CLINICAL TRIAL; DRUG BLOOD LEVEL; DRUG SAFETY; FEMALE; HUMAN; MALE; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SINGLE DRUG DOSE; TRANSURETHRAL RESECTION; TREATMENT OUTCOME; TUMOR RECURRENCE; TUMOR VOLUME;

EID: 3142616896     PISSN: 00225347     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.ju.0000131770.14409.7f     Document Type: Article

References (17)

1. Millan-Rodriguez, F., Chéchile-Toniolo, G., Salvador-Bayarri, J., Palou, J., Algaba, F. and Vicente-Rodriguez, J.: Primary superficial bladder cancer risk groups according to progression, mortality and recurrence. J Urol, 164: 680, 2000
2. Pawinski, A., Sylvester, R., Kurth, K. H., Bouffioux, C., Van Der Meijden, A., Parmar, M. K. B. et al: A combined analysis of European Organization for Research and Treatment of Cancer, and Medical Research Council randomized clinical trials for the prophylactic treatment of stage TaT1 bladder cancer. J Urol, 156: 1934, 1996
3. Solsona, E., Iborra, I., Ricos, J. V., Monros, J. L., Casanova, J. and Dumont, R.: Effectiveness of a single immediate mitomycin C instillation in patients with low risk superficial bladder cancer: short and long-term follow up. J Urol, 161: 1120, 1999
4. Tolley, D. A., Parmar, M. K. B., Grigor, K. M., Lallemand, G. and The Medical Research Council Superficial Bladder Cancer Working Party: The effect of intravesical mitomycin C on recurrence of newly diagnosed superficial bladder cancer: a further report with 7 wears of followup. J Urol, 155: 1233, 1996
5. Plunkett, W., Huang, P., Searcy, C. E. and Gandhi, V.: Gemcitabine: preclinical pharmacology and mechanisms of action. Semin Oncol, suppl., 23: 3, 1996
6. Burris, H. A., 3rd, Moore, M. J., Andersen, J., Green, M. R., Rothenberg, M. L., Modiano, M. R. 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, 15: 2403, 1997
7. Sandler, A. B., Nemunaitis, J., Denham, C., Von Pawel, J., Cormier, Y., Gatzemeier, U. 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, 18: 122, 2000
8. Lorusso, V., Pollera, C. F., Antimi, M., Luporini, G., Gridelli, C., Frassineti, G. L. et al: A phase II study of gemcitabine in patients with transitional cell carcinoma of the urinary tract previously treated with platinum. Italian Co-operative Group on Bladder Cancer. Eur J Cancer, 34: 1208, 1998
9. Moore, M. J., Tannock, I. F., Ernst, D. S., Huan, S. and Murray, N.: Gemcitabine: a promising new agent in the treatment of advanced urothelial cancer. J Clin Oncol, 15: 3441, 1997
10. Stadler, W. M., Kuzel, T., Roth, B., Raghavan, D. and Dorr, F. A.: Phase II study of single-agent gemcitabine in previously untreated patients with metastatic urothelial cancer. J Clin Oncol, 15: 3394, 1997
11. von der Maase, H., Hansen, S. W., Roberts, J. T., Dogliotti, L., Oliver, T., Moore, M. J. et al: 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, 18: 3068, 2000
12. Dalbagni, G., Russo, P., Sheinfeld, J., Mazumdar, M., Tong, W., Rabbani, F. et al: Phase I trial of intravesical gemcitabine in bacillus Calmette-Guerin-refractory transitional-cell carcinoma of the bladder. J Clin Oncol, 20: 3193, 2002
13. Venook, A. P., Egorin, M. J., Rosner, G. L., Hollis, D., Mani, S., Hawkins, M. et al: Phase I and pharmacokinetic trial of gemcitabine in patients with hepatic or renal dysfunction: Cancer and Leukemia Group B 9565. J Clin Oncol, 18: 2780, 2000
14. Laufer, M., Ramalingam, S., Schoenberg, M. P., Haisfield-Wolf, M. E., Zuhowski, E. G., Trueheart, I. N. et al: Intravesical gemcitabine therapy for superficial transitional cell carcinoma of the bladder: a phase I and pharmacokinetic study. J Clin Oncol, 21: 697, 2003
15. Roskos, L. K., Dhahir, P. H. and Allerheiligen, S. R. B.: Kinetics of gemcitabine deamination to 2′-deoxy-2′,2′-difluorouridine (dFdU) ex vivo in whole human blood and analysis of product inhibition. Pharmaceut Res, suppl., 12: S375, 1995
16. Danesi, R., Fogli, S., Donati, S., Bocci, G., Gennari, A., Innocenti, F. et al: Pharmacokinetics of gemcitabine, epirubicin, paclitaxel and their metabolites in advanced breast cancer patients. Proc Am Soc Clin Oncol, 18: 208, 1999
17. Peters, G. J., Ruiz Van Haperen, V. W. T., Noordhuis, P., Veerman, G. and Vermorken, J. B.: Clinical pharmacology of gemcitabine (2′,2′- difluorodeoxycytidine, dFdC) in relation to accumulation of its active metabolite dF-dCTP in normal and tumor cells. Eur J Cancer, 27: S195, 1991