A Phase I 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 Cancer

Protocol: 
AAAM8506
Phase: 
I

A Phase I 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 Cancer

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.

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States