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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcitabine induction | Experimental | Patients will receive Gemcitabine + Docetaxel once weekly for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine + docetaxel | Drug | The study drugs, Gemcitabine and Docetaxel, will be administered intravesically at 1000 mg and 40 mg, respectively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Complete response rate will be measured at the 3-month visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Duration of CR will be measured as change from the 3-month visit up to 12 months after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Specimens will be collected from the first TURBT (occuring between 1-3 weeks prior to treatment) |
Inclusion Criteria:
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.
6. Eastern Cooperative Oncology Group (ECOG) performance status Grade 0-2. 7. Post-transurethral bladder tumor resection. 8. 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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan Chipollini, MD | Contact | (520) 626-6895 | jchipollini@urology.arizona.edu | |
| Michele Chu-Pilli | Contact | (520) 626-1183 | chum@arizona.edu |
| Name | Affiliation | Role |
|---|---|---|
| Juan Chipollini, MD | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Cancer Center | Recruiting | Tucson | Arizona | 85721 | United States |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| 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. | Toxicity assessment will be evaluated at the 3-month visit |
| 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. | The assessment will be done at the 3-month visit |
| 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. | Through study completion, an average of 1 year |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |