Intravesical Gem/Doce in Patients With NMIBC

NCT05644041 | Recruiting Phase 2 FDA Drug

• 1 other identifier: STUDY00000198
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Bladder Cancer

Keywords

Bacillus Calmette-Guérin (BCG); Nonmuscle invasive bladder cancer (NMIBC); Intravesical immunotherapy; Post-transurethral resection

Outcome Measures

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.

  Complete response rate will be measured at the 3-month visit

Secondary Outcomes (4)

• 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

• Tolerability and safety of the treatment

  Toxicity assessment will be evaluated at the 3-month visit

• Proportion of patients who accept maintenance therapy

  The assessment will be done at the 3-month visit

• Rate and reasons for cystectomy (if any)

  Through study completion, an average of 1 year

Other Outcomes (1)

• 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)

Study Arms (1)

Gemcitabine induction

EXPERIMENTAL

Patients will receive Gemcitabine + Docetaxel once weekly for 6 weeks.

Drug: gemcitabine + docetaxel

Interventions

gemcitabine + docetaxel DRUG

The study drugs, Gemcitabine and Docetaxel, will be administered intravesically at 1000 mg and 40 mg, respectively.

Gemcitabine induction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \. 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona Cancer Center

Tucson, Arizona, 85721, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Gemcitabine; Docetaxel

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Juan Chipollini, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Chipollini, MD

CONTACT

(520) 626-6895; jchipollini@urology.arizona.edu

Michele Chu-Pilli

CONTACT

(520) 626-1183; chum@arizona.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 9, 2022
• Study Start: March 1, 2023
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)