Intravesical Gemcitabine in Patients With NMIBC
Study Details
Study Description
Brief Summary
Intravesical immunotherapy or chemotherapy for non-muscle invasive bladder cancer is a well-established treatment for preventing or delaying tumor recurrence after bladder 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. In addition, nationwide shortages of BCG have pushed the use of alternative intravesical therapies for non-muscle invasive bladder cancer. At Banner University Medical-Tucson, the use of intravesical Gemcitabine is considered as standard treatment for patients with bladder cancer who are unable to get BCG or have failed prior BCG treatment. The role of Gemcitabine as treatment for NBMIC is poorly understood. The purpose of this study is to gain a better understanding of the use of Gemcitabine intravesical chemotherapy for non-muscle invasive bladder cancer in a prospective cohort of patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Gemcitabine induction Patients will receive Gemcitabine once weekly for 6 weeks. |
Drug: Gemcitabine
Gemcitabine will be administered intravesically at a dose of 2000 mg.
|
Outcome Measures
Primary Outcome Measures
- Complete response rate (CR) for treatment with intravesical gemcitabine for patients with intermediate and high-risk NMIBC [Complete response rate will be measured at the 3-month visit]
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.
Secondary Outcome Measures
- Durability of response in patients who achieve CR [Duration of CR will be measured as change from the 3-month visit up to 12 months after treatment initiation]
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.
- Tolerability and safety of the treatment [Toxicity assessment will be evaluated at the 3-month visit]
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.
- Proportion of patients who accept maintenance therapy [The assessment will be done at the 3-month visit]
To assess the number of patients who are agreeable to monthly maintenance therapy for 10 months as per patient and physician discretion.
- Rate and reasons for cystectomy (if any) [Through study completion, an average of 1 year]
To assess rate of salvage cystectomy and reasons for cystectomy at the time of tumor recurrence (if any) after treatment with gemcitabine.
Other Outcome Measures
- Specimen collection as part of standard of care for future exploratory research [Specimens will be collected from the first TURBT (occuring between 1-3 weeks prior to treatment)]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Provision of signed and dated informed consent form
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Stated willingness to comply with all study procedures and availability for the duration of the study
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Male or female ages ≥18 years.
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Patients with intermediate or high-risk non-muscle-invasive UC of the bladder and no previous BCG treatment.
- Histologically confirmed intermediate or high-risk non-muscle invasive urothelial carcinoma of the bladder (Ta, T1, or Tis stage) on Transurethral Resection of Bladder Tumor (TURBT) must be obtained within 90 days of registration.
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Patients with a high-grade recurrence after 24 months since last dose of BCG.
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Eastern Cooperative Oncology Group (ECOG) performance status Grade 0-2.
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Post-transurethral bladder tumor resection.
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Evidence of post-menopausal status or negative urinary pregnancy test of female pre-menopausal patients is required. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.
Exclusion Criteria:
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Known hypersensitivity reaction to gemcitabine.
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Clinical T2 or higher stage UC of the bladder.
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Histopathology demonstrating any small cell component, pure adenocarcinoma, pure squamous cell carcinoma, or pure CIS of the bladder.
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Active malignancies other than the disease being treated under study.
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Subjects with concurrent upper urinary tract (i.e. ureter, renal pelvis) urothelial carcinoma of any stage.
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Pregnant or breast-feeding women.
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Has an underlying substance abuse or psychiatric disorder such that, in the opinion of the investigator, the patient would be unable to comply with the protocol.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Arizona Cancer Center | Tucson | Arizona | United States | 85721 |
Sponsors and Collaborators
- University of Arizona
Investigators
- Principal Investigator: Juan Chipollini, MD, University of Arizona
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00000198