Clinical trial NCT05644041: Intravesical Gem/Doce in Patients With NMIBC
Official title: Phase II Trial of Intravesical Gemcitabine + Docetaxel in Patients With Nonmuscle Invasive Bladder Cancer With or Without Prior Bacillus Calmette-Guérin Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Urinary Bladder Cancer
Keywords: Bacillus Calmette-Guérin (BCG)
Nonmuscle invasive bladder cancer (NMIBC)
Intravesical immunotherapy
Post-transurethral resection
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Patients able to consent in English or Spanish; provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female ages ≥18 years.
4. Patients with intermediate or high-risk non-muscle-invasive UC of the bladder and no previous BCG treatment.

   1. 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:

1. Known hypersensitivity reaction to gemcitabine and/or docetaxel.
2. Clinical T2 or higher stage UC of the bladder.
3. Histopathology demonstrating any small cell component, pure adenocarcinoma, pure squamous cell carcinoma, or pure CIS of the bladder.
4. Active malignancies other than the disease being treated under study.
5. Subjects with concurrent upper urinary tract (i.e. ureter, renal pelvis) urothelial carcinoma of any stage.
6. Pregnant or breast-feeding women.
7. 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.

Primary outcomes:
measure: Complete response rate (CR) for treatment with intravesical gemcitabine for patients with intermediate and high-risk NMIBC
timeFrame: Complete response rate will be measured at the 3-month visit
Secondary outcomes:
measure: Durability of response in patients who achieve CR
timeFrame: Duration of CR will be measured as change from the 3-month visit up to 12 months after treatment initiation
measure: Tolerability and safety of the treatment
timeFrame: Toxicity assessment will be evaluated at the 3-month visit
measure: Proportion of patients who accept maintenance therapy
timeFrame: The assessment will be done at the 3-month visit
measure: Rate and reasons for cystectomy (if any)
timeFrame: Through study completion, an average of 1 year
Other outcomes:
measure: Specimen collection as part of standard of care for future exploratory research
timeFrame: Specimens will be collected from the first TURBT (occuring between 1-3 weeks prior to treatment)
Locations:
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Juan Chipollini, MD
role: PRINCIPAL_INVESTIGATOR
References: