NCT05671900

Gemcitabine and Docetaxel Therapy in High-risk BCG-naive Patients With Non-muscle Invasive Bladder Cancer

The Efficacy of Sequential Intravesical Gemcitabine and Docetaxel Therapy (GEM/DOCE) in High-risk BCG-naive Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Clinical Hospital Centre Zagreb · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Bacillus Calmette-Guerin (BCG) is the standard of care for high-risk patients with non-muscle invasive bladder cancer (NMIBC) after transurethral tumor resection. Since 2012, global BCG shortage encouraged the search of alternative treatment for NMIBC treatment. Intravesical gemcitabine and docetaxel chemotherapy (GEM/DOCE) has shown safety and efficacy in 2 retrospective, single institution cohorts. At our institution, GEM/DOCE has been offered as an option for NMIBC in the treatment of high-risk BCG-naive patients per the protocol adapted from University of Iowa, in shortage situation. Our objective is to evaluate the efficacy of GEM/DOCE therapy.

Conditions

• Non-muscle-invasive Bladder Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine 1000 mg, Docetaxel 37.5g	6 weekly instillations of gemcitabine (1 gram of gemcitabine in 50 ml of sterile water) followed immediately by docetaxel (37.5 mg of docetaxel in 50 mL of saline) and subsequent monthly maintenance installations for those with no evidence of disease.

Timeline

• Start date: 2020-04-01
• Primary completion: 2024-06-01
• Completion: 2024-12-01
• First posted: 2023-01-05
• Last updated: 2024-03-08

Locations

1 site across 1 country: Croatia