Phase II Trial of Intravesical Gemcitabine + Docetaxel in Patients With Nonmuscle Invasive Bladder Cancer With or Without Prior Bacillus Calmette-Guérin Therapy
Summary
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.
Arms & interventions
- Druggemcitabine + docetaxel
The study drugs, Gemcitabine and Docetaxel, will be administered intravesically at 1000 mg and 40 mg, respectively.
Outcome measures
Primary
Complete response rate (CR) for treatment with intravesical gemcitabine for patients with intermediate and high-risk NMIBC
The primary outcome measure will be CR rate, defined as the percentage of patients with CR at the 3-month visit. An event will be defined as the earliest date of recurrence as determined using the date of cystoscopy, biopsy, or cytology, whichever occurs first.
Time frame: Complete response rate will be measured at the 3-month visit
Secondary
Durability of response in patients who achieve CR
Time frame: Duration of CR will be measured as change from the 3-month visit up to 12 months after treatment initiation
Tolerability and safety of the treatment
Time frame: Toxicity assessment will be evaluated at the 3-month visit
Proportion of patients who accept maintenance therapy
Time frame: The assessment will be done at the 3-month visit
Rate and reasons for cystectomy (if any)
Time frame: Through study completion, an average of 1 year
Eligibility criteria
Study locations (1)
University of Arizona Cancer Center
Tucson, Arizona, 85721