Paclitaxel-Hyaluronic Acid for Intravesical Therapy of Bacillus Calmette-Guérin Refractory Carcinoma In Situ of the Bladder: Results of a Phase I Study

No AccessJournal of UrologyAdult Urology1 Feb 2011Paclitaxel-Hyaluronic Acid for Intravesical Therapy of Bacillus Calmette-Guérin Refractory Carcinoma In Situ of the Bladder: Results of a Phase I Study P.F. Bassi, A. Volpe, D. D'Agostino, G. Palermo, D. Renier, S. Franchini, A. Rosato, and M. Racioppi P.F. BassiP.F. Bassi Department of Urology, Catholic University School of Medicine, Rome, Italy , A. VolpeA. Volpe Department of Urology, Catholic University School of Medicine, Rome, Italy , D. D'AgostinoD. D'Agostino Department of Urology, Catholic University School of Medicine, Rome, Italy , G. PalermoG. Palermo Department of Urology, Catholic University School of Medicine, Rome, Italy , D. RenierD. Renier Fidia Farmaceutici S.p.A. – Abano Terme, Italy , S. FranchiniS. Franchini Fidia Farmaceutici S.p.A. – Abano Terme, Italy , A. RosatoA. Rosato Department of Oncology and Surgical Sciences, University of Padova, and Istituto Oncologico Veneto IRCCS, Padova, Italy , and M. RacioppiM. Racioppi Department of Urology, Catholic University School of Medicine, Rome, Italy View All Author Informationhttps://doi.org/10.1016/j.juro.2010.09.073AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: Carcinoma in situ represents high grade anaplasia of the bladder mucosa. Intravesical immunotherapy with bacillus Calmette-Guérin is the gold standard treatment for patients with carcinoma in situ. Patients with carcinoma in situ refractory to bacillus Calmette-Guérin are candidates for major surgery such as radical cystectomy. We identified the maximum tolerated dose and the recommended dose, and evaluated the safety profile of paclitaxel-hyaluronic acid bioconjugate given by intravesical instillation to patients with carcinoma in situ refractory to bacillus Calmette-Guérin. Materials and Methods: A total of 16 patients with carcinoma in situ refractory to bacillus Calmette-Guérin were enrolled in a phase I, open label, single institution study. A minimum of 3 eligible patients were included per dose level. Paclitaxel-hyaluronic acid solution (ONCOFID-P-B™) was administered for 6 consecutive weeks. The primary objective was to identify the maximum tolerated dose and the recommended dose. As secondary objectives the safety profile of ONCOFID-P-B, the pharmacokinetic profile after each instillation and the tumor response were also evaluated. Results: No dose limiting toxicity occurred at any drug level evaluated. The plasma levels of the study drug were always below the lower limit of quantification at all tested doses after each instillation. A total of 11 adverse events were reported by 7 patients and 9 (60%) showed complete treatment response. 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Volume 185 Issue 2 February 2011 Page: 445-449 Advertisement Copyright & Permissions© 2011 by American Urological Association Education and Research, Inc.Keywordspaclitaxelhyaluronic acidadministrationintravesicalcarcinoma in situurinary bladderMetrics Author Information P.F. Bassi Department of Urology, Catholic University School of Medicine, Rome, Italy More articles by this author A. Volpe Department of Urology, Catholic University School of Medicine, Rome, Italy More articles by this author D. D'Agostino Department of Urology, Catholic University School of Medicine, Rome, Italy More articles by this author G. Palermo Department of Urology, Catholic University School of Medicine, Rome, Italy More articles by this author D. Renier Fidia Farmaceutici S.p.A. – Abano Terme, Italy More articles by this author S. Franchini Fidia Farmaceutici S.p.A. – Abano Terme, Italy More articles by this author A. Rosato Department of Oncology and Surgical Sciences, University of Padova, and Istituto Oncologico Veneto IRCCS, Padova, Italy More articles by this author M. Racioppi Department of Urology, Catholic University School of Medicine, Rome, Italy More articles by this author Expand All Advertisement PDF downloadLoading ...