Single Arm Phase I/II Study of Everolimus and Intravesical Gemcitabine in Patients with Primary or Secondary Carcinoma In Situ of the Bladder who failed Bacillus Calmette Guerin (NCT01259063)

Bladder Cancer
Guido DalbagniDean Bajorin

Abstract

Background: Standard treatment for BCG-refractory urothelial cancer is radical cystectomy. Identification of active agents is clearly warranted. Objective: To determine a safe dose of oral everolimus in combination with standard intravesical gemcitabine and to evaluate the efficacy of this combination. Methods: Patients with carcinoma in situ refractory to intravesical bacillus Calmette-Guérin and refusing cystectomy were eligible. Patients in the phase I part of the trial received one of three dose levels of oral everolimus. Patients also received a fixed dose of intravesical gemcitabine. Maintenance everolimus was given for 12 months in patients achieving a complete response confirmed by cystoscopy and cytology. Patients in phase II received continuous everolimus administered at 10 mg daily with intravesical gemcitabine followed by everolimus maintenance for 12 months of total therapy. The enrollment goal for the phase II was 33 patients. Results: 14 patients were enrolled in phase I of the trial. 23 patients were enrolled in phase II of the trial and 19 were evaluable for primary and secondary endpoints. Four patients withdrew consent prior to treatment initiation. Of the 19 patients evaluable for response, 3 (16%, 95% confi...Continue Reading

References

Jun 1, 1997·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·H A BurrisD D Von Hoff
Nov 18, 1997·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·W M StadlerF A Dorr
Mar 4, 2000·The Urologic Clinics of North America·G Dalbagni, H W Herr
Jul 22, 2005·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Hans von der MaaseMichael Arning
Dec 7, 2005·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·C N SternbergUNKNOWN EORTC Genito-Urinary Cancer Group
Jun 20, 2006·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Guido DalbagniDean Bajorin
Aug 19, 2007·European Surgical Research. Europäische Chirurgische Forschung. Recherches Chirurgicales Européennes·P TuncyurekS Stracke
Jun 16, 2010·The Journal of Urology·Daher C ChadeGuido Dalbagni
Mar 19, 2011·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Edmund ChiongH Barton Grossman
Jul 14, 2012·Journal of Toxicology and Environmental Health. Part a·Rosário Pinto-LeitePaula Oliveira
Apr 5, 2013·BJU International·Matthew I MilowskyDean F Bajorin
Jan 9, 2016·CA: a Cancer Journal for Clinicians·Rebecca L SiegelAhmedin Jemal

❮ Previous
Next ❯

Methods Mentioned

BETA
biopsies

Related Concepts

Related Feeds

Bladder Carcinoma In Situ

Bladder Carcinoma In Situ is a superficial bladder cancer that occurs on the surface layer of the bladder. Discover the latest research on this precancerous condition in this feed.