Intravesical Gem/Doce in Patients With NMIBC

Part of paid clinical trials in Tucson, Arizona.

Sponsor
University of Arizona
Study ID
NCT05644041
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Urinary Bladder Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • gemcitabine + docetaxel — DRUG
    The study drugs, Gemcitabine and Docetaxel, will be administered intravesically at 1000 mg and 40 mg, respectively.

Study Details

Intravesical immunotherapy or chemotherapy for non-muscle invasive bladder cancer (NMIBC) is a well-established treatment for preventing or delaying tumor recurrence after tumor resection. For high-risk non-muscle invasive bladder cancer, immunotherapy in the form of intravesical Bacillus Calmette-Guérin (BCG) can be effective as first-line; nevertheless, the response rate to BCG is suboptimal with many patients failing treatment. Following BCG-failure, however, very few effective therapeutic options exist besides life-changing cystectomy. Recent shortages of BCG have pushed the use of alternative intravesical therapies for non-muscle invasive bladder cancer. At the University of Arizona Cancer Center, the use of intravesical Gemcitabine + Docetaxel (Gem/Doce) is considered as standard treatment for patients with non-invasive bladder cancer who are unable to get BCG or are BCG-resistant. The role of Gemcitabine as first-line treatment for NMIBC is poorly understood. The purpose of this study is to gain a better understanding of the use of Gemcitabine + Docetaxel intravesical chemotherapy for non-muscle invasive bladder cancer.

Key Dates

Start date
Mar 1, 2023
Status verified
Feb 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Gemcitabine induction
    Patients will receive Gemcitabine + Docetaxel once weekly for 6 weeks.

Primary Outcome Measure

Complete response rate (CR) for treatment with intravesical gemcitabine for patients with intermediate and high-risk NMIBC [ Time Frame: Complete response rate will be measured at the 3-month visit ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Arizona Cancer CenterTucsonArizona85721
Michele Chu-Pilli
[email protected]
UACC IIT
[email protected]

Find similar trials in Tucson, AZ

By research site
University of Arizona Cancer Center· Tucson, AZ

Related Studies