CGC Therapy for Bladder Cancer
(CGC Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byGuarionex DeCastro, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Guarionex J. Decastro

No Placebo Group

Trial Summary

What is the purpose of this trial?The investigators intend to evaluate the safety and toxicity proﬁle of intravesically administered multidrug regimen of Cabazitaxel, Cisplatin and Gemcitabine in treatment refractory Transitional Cell Carcinoma.The investigators propose to conduct a combined phase I trial to assess the safety, toxicity, and efﬁcacy of a novel multidrug intravesical regimen consisting of Cabazitaxel, Gemcitabine, and Cisplatin (CGC) in the treatment of BCG resistant non-muscle invasive urothelial carcinoma of the bladder. This phase I trial will have a combined dose and cycle-escalation scheme with enrollment of up to 24 patients.

Eligibility Criteria

This trial is for adults over 18 with non-muscle invasive bladder cancer resistant to BCG therapy. They must be eligible for but not wanting or able to undergo radical cystectomy, have an ECOG status of 0 or 1, and agree to use effective contraception. Exclusions include severe drug allergies, recent participation in other trials, certain treatments within the last 6 weeks, concurrent cancers or chemotherapy, and inadequate organ function.

Inclusion Criteria

All visible bladder cancer has been surgically removed and its stage confirmed.

All patients of childbearing potential must be willing to consent to using effective contraception while on treatment and for 3 months after their participation in the study ends

My bladder cancer is confirmed and not spread into the muscle.

+9 more

Exclusion Criteria

I have a history of bladder reflux or currently have a urinary stent.

You have had a very bad allergic reaction to drugs containing polysorbate 80 in the past.

My organ and bone marrow functions are not meeting certain health standards.

+7 more

Participant Groups

The study tests a new combination of drugs (Cabazitaxel, Gemcitabine, Cisplatin) given directly into the bladder for those whose bladder cancer hasn't responded to standard treatment. Up to 24 patients will join this phase I trial which aims to find out how safe the treatment is and what dose is best.

5Treatment groups

Experimental Treatment

Group I: Gem, High Cab, and Low CisExperimental Treatment3 Interventions

Gemcitabine: Intravesical; 2000mg/100ml; 1 time a week for 6 weeks; 2 hours Cabazitaxel: Intravesical; 5mg/100ml; 1 time a week for 6 weeks; 2 hours Cisplatin: Intravesical; 66mg/100ml; 1 time a week for 6 weeks; 2 hours

Group II: Gem, High Cab, Mod CisExperimental Treatment3 Interventions

Gemcitabine: Intravesical; 2000mg/100ml; 1 time a week for 6 weeks; 2 hours Cabazitaxel: Intravesical; 5mg/100ml; 1 time a week for 6 weeks; 2 hours Cisplatin: Intravesical; 80mg/100ml; 1 time a week for 6 weeks; 2 hours

Group III: Gem, High Cab, High CisExperimental Treatment3 Interventions

Gemcitabine: Intravesical; 2000mg/100ml; 1 time a week for 6 weeks; 2 hours Cabazitaxel: Intravesical; 5mg/100ml; 1 time a week for 6 weeks; 2 hours Cisplatin: Intravesical; 100mg/100ml; 1 time a week for 6 weeks; 2 hours

Group IV: Gem and Low CabExperimental Treatment2 Interventions

Gemcitabine: Intravesical; 2000mg/100ml; 1 time a week for 6 weeks; 2 hours Cabazitaxel: Intravesical; 2.5mg/100ml; 1 time a week for 6 weeks; 2 hours

Group V: Gem and High CabExperimental Treatment2 Interventions

Gemcitabine: Intravesical; 2000mg/100ml; 1 time a week for 6 weeks; 2 hours Cabazitaxel: Intravesical; 5mg/100ml; 1 time a week for 6 weeks; 2 hours

Cabazitaxel is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Jevtana for: