Gemcitabine + Docetaxel for Bladder Cancer
(GEMDOCE Trial)

Recruiting in Palo Alto (17 mi)

Overseen byMax Kates, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?A single-arm, two-stage, open-label, phase 2 study investigating the safety and efficacy of intravesical gemcitabine/docetaxel for bacillus Calmette-Guerin (BCG)-naïve patients with non-muscle invasive bladder cancer (NMIBC).

Eligibility Criteria

This trial is for adults with early-stage bladder cancer that hasn't spread into the muscle. They should be in fairly good health, not pregnant or breastfeeding, and haven't had certain cancer treatments recently. People with more advanced cancer, another serious active cancer, or those who've used gemcitabine or docetaxel for other cancers can't join.

Inclusion Criteria

Subjects who give a written informed consent obtained according to local guidelines

I am post-menopausal or not pregnant.

I am able to care for myself and perform daily activities.

+2 more

Exclusion Criteria

I have another cancer with a life expectancy of less than 12 months.

I received cancer treatment less than 4 weeks ago or am still experiencing side effects.

I had radiotherapy less than 4 weeks ago or still have side effects.

+5 more

Participant Groups

The study tests a combination of two drugs, Gemcitabine and Docetaxel, given directly into the bladder to treat patients who have never received BCG therapy. It's an open-label phase 2 study which means everyone gets the treatment and researchers track its safety and effectiveness.

1Treatment groups

Experimental Treatment

Group I: Intravesical Gemcitabine/DocetaxelExperimental Treatment2 Interventions

Gemcitabine/Docetaxel induction is given intravesically in sequential order once a week for six consecutive weeks. One gram of gemcitabine in 50 ml of sterile water is slowly instilled into the bladder via a Foley catheter and the catheter is clamped for 60 minutes. The bladder is then drained and 40 mg of docetaxel in 50 ml of NSS is then slowly instilled via the Foley catheter into the bladder. The catheter is again clamped for 60 minutes before draining. If initial efficacy seen, patients will have monthly maintenance instillations of Gemcitabine/Docetaxel.

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

🇺🇸 Approved in United States as Taxotere for: