Intravesical Gem/Doce in Patients With NMIBC
ConditionUrinary Bladder Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Arizona
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients able to consent in English or Spanish; provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female ages ≥18 years.
Patients with intermediate or high-risk non-muscle-invasive UC of the bladder and no previous BCG treatment.
Disqualifiers
Known hypersensitivity reaction to gemcitabine and/or docetaxel.
Clinical T2 or higher stage UC of the bladder.
Histopathology demonstrating any small cell component, pure adenocarcinoma, pure squamous cell carcinoma, or pure CIS of the bladder.
Active malignancies other than the disease being treated under study.
Trial design
Design model
Single group
Treatments tested in this trial
gemcitabine + docetaxel
DrugThe study drugs, Gemcitabine and Docetaxel, will be administered intravesically at 1000 mg and 40 mg, respectively.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Gemcitabine inductionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 visitSecondary outcomes
1
Durability of response in patients who achieve CR
To assess durable CR in patients who achieved CR at the 3-month visit, defined as the percentage of patients with no detectable disease 6, 9, and 12 months after treatment initiation. Duration of CR will be defined as the time from the date of evidence of CR at the 3-month visit to the earliest date of recurrence.
Time frame
Duration of CR will be measured as change from the 3-month visit up to 12 months after treatment initiation2
Tolerability and safety of the treatment
To assess adverse events using the Medical Dictionary for Regulatory Activities (MedDRA) version 21.0 and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Adverse events will be monitored during the course of treatment, and a toxicity assessment will be done after completion of treatment that will descriptively summarize any treatment-related adverse events that occur on or after the date of the first instillation of gemcitabine.
Time frame
Toxicity assessment will be evaluated at the 3-month visit3
Proportion of patients who accept maintenance therapy
To assess the number of patients who are agreeable to monthly maintenance therapy for 10 months as per patient and physician discretion.
Time frame
The assessment will be done at the 3-month visit4
Rate and reasons for cystectomy (if any)
To assess rate of salvage cystectomy and reasons for cystectomy at the time of tumor recurrence (if any) after treatment with gemcitabine.
Time frame
Through study completion, an average of 1 yearOther outcomes
1
Specimen collection as part of standard of care for future exploratory research
Tissue will be collected for future exploratory analyses. Collected tissue will be stored at the University of Arizona Cancer Center Tissue Acquisition and Cellular/Molecular Analysis Shared Resource (TACMASR) for use in future studies but will not be directly assessed for the purposes of this study.
Time frame
Specimens will be collected from the first TURBT (occuring between 1-3 weeks prior to treatment)Sponsors and contacts
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Source ClinicalTrials.gov