Using Gemcitabine and Docetaxel for Bladder Cancer Treatment

Phase II Trial of Intravesical Gemcitabine + Docetaxel in Patients With Nonmuscle Invasive Bladder Cancer With or Without Prior Bacillus Calmette-Guérin Therapy

This study is testing if a combination of Gemcitabine and Docetaxel can help patients with non-muscle invasive bladder cancer who can't use or didn't respond to the standard BCG treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Arizona (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Tucson, Arizona)
• Trial ID: NCT05644041 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of intravesical Gemcitabine and Docetaxel in treating patients with non-muscle invasive bladder cancer (NMIBC) who are either unable to receive Bacillus Calmette-Guérin (BCG) therapy or have not responded to it. The study aims to provide an alternative treatment option for high-risk patients following BCG failure, addressing the current shortage of BCG and the limited options available for these patients. Participants will receive the combination of Gemcitabine and Docetaxel after undergoing transurethral resection of bladder tumors. The trial is conducted at the University of Arizona Cancer Center.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with intermediate or high-risk NMIBC who have not previously received BCG treatment.

Not a fit: Patients with muscle-invasive bladder cancer or those who have previously undergone BCG treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients with NMIBC who do not respond to BCG therapy.

How similar studies have performed: While the use of Gemcitabine and Docetaxel is being explored, the specific combination for NMIBC treatment is relatively novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Tucson, Arizona

• University of Arizona Cancer Center — Tucson, Arizona, United States (Recruiting)

Study contacts

• Principal investigator: Juan Chipollini, MD — University of Arizona
• Study coordinator: Juan Chipollini, MD

Conditions Urinary Bladder Cancer; Bacillus Calmette-Guérin; Nonmuscle invasive bladder cancer; Intravesical immunotherapy; Post-transurethral resection