Back to resultsIntravesical Gemcitabine in Patients With NMIBC
Primary Purpose
Urinary Bladder Cancer
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Bladder Cancer focused on measuring Bacillus Calmette-Guérin (BCG), Nonmuscle invasive bladder cancer (NMIBC), Intravesical immunotherapy, Post-transurethral resection
Eligibility Criteria
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. 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 180 days of registration. OR Patients with a high-grade recurrence after 24 months since last dose of BCG. 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: Known hypersensitivity reaction to gemcitabine. 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. Subjects with concurrent upper urinary tract (i.e. ureter, renal pelvis) urothelial carcinoma of any stage. Pregnant or breast-feeding women. 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.
Sites / Locations
- University of Arizona Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gemcitabine induction
Arm Description
Patients will receive Gemcitabine once weekly for 6 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05644041
Brief Title
Intravesical Gemcitabine in Patients With NMIBC
Official Title
Phase II Trial of Intravesical Gemcitabine in Patients With Nonmuscle Invasive Bladder Cancer With or Without Prior Bacillus Calmette-Guérin Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder Cancer
Keywords
Bacillus Calmette-Guérin (BCG), Nonmuscle invasive bladder cancer (NMIBC), Intravesical immunotherapy, Post-transurethral resection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gemcitabine induction
Arm Type
Experimental
Arm Description
Patients will receive Gemcitabine once weekly for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine will be administered intravesically at a dose of 2000 mg.
Primary Outcome Measure Information:
Title
Complete response rate (CR) for treatment with intravesical gemcitabine for patients with intermediate and high-risk NMIBC
Description
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 Outcome Measure Information:
Title
Durability of response in patients who achieve CR
Description
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 initiation
Title
Tolerability and safety of the treatment
Description
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 visit
Title
Proportion of patients who accept maintenance therapy
Description
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 visit
Title
Rate and reasons for cystectomy (if any)
Description
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 year
Other Pre-specified Outcome Measures:
Title
Specimen collection as part of standard of care for future exploratory research
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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 180 days of registration. OR Patients with a high-grade recurrence after 24 months since last dose of BCG.
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:
Known hypersensitivity reaction to gemcitabine.
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.
Subjects with concurrent upper urinary tract (i.e. ureter, renal pelvis) urothelial carcinoma of any stage.
Pregnant or breast-feeding women.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Chipollini, MD
Phone
(520) 626-6895
Email
jchipollini@urology.arizona.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Michele Chu-Pilli
Phone
(520) 626-1183
Email
chum@arizona.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Chipollini, MD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85721
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Chu-Pilli
Email
chum@arizona.edu
First Name & Middle Initial & Last Name & Degree
UACC IIT
Email
UACC-IIT@uacc.arizona.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Intravesical Gemcitabine in Patients With NMIBC
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