A Phase 1/2 trial for the use of Intravesical Cabazitaxel, Gemcitabine, and Cisplatin (CGC) in the treatment of BCG-Refractory Non-muscle invasive Urothelial Carcinoma of the Bladder
Are you Eligible? (Inclusion Criteria)
- Inclusion Criteria:
- 1) The patient must be at least 18 years of age.
- 2)Patients must have a histologically confirmed diagnosis of non- muscle invasive urothelial carcinoma of the bladder at the study institution prior to the beginning of the study. This includes patients with:
- • High grade Ta papillary lesion(s)
- • High or low grade T1 papillary lesion(s)
- • CIS, with or without Ta or T1 papillary tumor(s) of any grade
- 3)The patient must have BCG refractory or recurrent non-muscle invasive bladder cancer
- • Refractory disease is defined as evidence of persistent high risk bladder cancer (Ta, T1 and/or CIS) at the first cystoscopic exam after the initial 6 week induction course of BCG or at the 6 month cystoscopic exam.
- • Recurrent disease is defined as reappearance of disease after achieving a tumor- free status by 6 months following a full induction course of BCG with or without maintenance BCG. Participants must have recurred within 18 months following the last dose of BCG.
- 4)Patients must be eligible for radical cystectomy and refuse this standard of care treatment or not be a surgical candidate for radical cystectomy based on other comorbidities.
- Exclusion Criteria:
- 1)History of severe hypersensitivity reaction (≥grade 3) to docetaxel
- 2)History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs
- 3) Women who are pregnant or lactating.