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Intravesical Gemcitabine and Docetaxel for BCG-Unresponsive Bladder Cancer

This study is testing if a combination of two chemotherapy drugs, Gemcitabine and Docetaxel, can treat high-grade non-muscle-invasive bladder cancer (NMIBC) that has not responded to standard BCG therapy. The drugs are given directly into your bladder (intravesically) through a catheter, one after the other. Each drug stays in your bladder for 60 minutes. The treatment starts with weekly instillations for six weeks. The study aims to see how well this treatment works at 3 months for different types of NMIBC, specifically carcinoma in situ (CIS) and papillary tumors, and to understand any side effects. You may be eligible if you are between 18 and 99 years old with a confirmed diagnosis of bladder cancer that has not spread to your upper urinary tract or prostatic urethra. The planned enrollment for this study is 174 participants.

Study design
This is an interventional study with a planned enrollment of 174 participants. It will evaluate the efficacy of the treatment in two groups: those with carcinoma in situ (CIS) and those with high-grade papillary tumors.
What's involved
The treatment involves weekly instillations of Gemcitabine and Docetaxel into the bladder for a 6-week induction phase. Success will be measured at approximately 3 months through procedures like cystoscopy, urine cytology, and bladder biopsy.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints for efficacy are measured at 3 months after treatment. Other outcomes like high-grade recurrence-free survival and overall survival will also be evaluated.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07322263

Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC

Recruiting
PHASE2Ages 18–99InterventionalTreatment
Michael A. O'Donnell
~174 participants
Updated 2026-04-17 on ClinicalTrials.gov
What's tested:Intravesical Gemcitabine and Docetaxel

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Efficacy of Intravesical Gemcitabine/Docetaxel in BCG-Unresponsive Carcinoma In Situ NMIBC
Measured over 3 months
+1 more outcome measured

Conditions

Bladder Cancer
Non-Muscle Invasive Bladder Cancer (NMIBC)
Urothelial Carcinoma
Carcinoma in Situ (CIS)
High-Grade Papillary Bladder Tumors
BCG-Unresponsive Bladder Cancer
Ta Stage Bladder Cancer
T1 Stage Bladder Cancer
BCG-Refractory Bladder Cancer
High-Risk NMIBC
Micropapillary Variant Urothelial Carcinoma (Favorable Subtype)

Explore related trials

Bladder CarcinomaCarcinoma In Situ

NCT07322263

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Iowa

    Iowa City, Iowastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Michael A O'Donnell, MD · PRINCIPAL_INVESTIGATOR · University of Iowa

Who to contact

Denise Juhr, BS
[email protected]
(319) 467-6313
Email the study team

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Eligibility criteria

Inclusion

Carcinoma in situ (CIS), with or without non-muscle-invasive stage Ta or T1 tumors of any grade.
High-Grade Papillary tumors (stages Ta and/or T1) without CIS.
All visible bladder tumors must be completely resected within 8 weeks prior to initiating intravesical Gem/Doce therapy.
If more than 8 weeks have passed since diagnosis or resection of index bladder CIS ± non-invasive tumor (pTa or T1 tumors), an office cystoscopy must be performed within 8 weeks of Gem/Doce initiation to confirm no visible tumor regrowth.
Occurrence of high-grade, stage T1 cancer after at least 5/6 weekly BCG induction treatments.
Occurrence of CIS within 12 months, or high-grade papillary disease, stage Ta/T1, within 6 months after an "adequate" course of BCG therapy.
N.B: Physician may have some flexibility (+/- 1 month) in the use of 6 and 12 months to define BCG-unresponsive NMIBC.
N.B: Once a patient has been correctly defined as having BCG-unresponsive disease, they will be considered to always be BCG-unresponsive for the purpose of this study. In other words, there is no restriction as to when the BCG-unresponsive term was assigned.
The occurrence of low-grade (LG) Ta disease will not be considered a HG relapse event given its prognosis is much more favorable that HG disease. However, all LG tumor must be completely resected before continuing with Gemcitabine/Docetaxel therapy.
Subjects must be eligible for radical cystectomy and decline this standard of care treatment or not be a surgical candidate for radical cystectomy (as appropriate) based on other comorbidities.
All grossly visible disease in the bladder must be fully resected with pathologic stage and grade assessed at the local study institution. Local pathologists are strongly encouraged to use the current LG and HG AJCC criteria.
Patients enrolled in other clinical trials must have received their last treatment at least 8 weeks prior to enrollment if the treatment was an intravesical agent. If the treatment included a systemic immune-modulating agent (e.g. anti-PD(L)-1 or anti CTLA4) then at least two dosing intervals must have elapsed untreated before the patient is eligible.
Age \> 18 and must be able to read, understand and sign the local informed consent.
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance Status of 2 or less, including patients who are not surgical candidates due to comorbid conditions.
Women of childbearing potential must have a negative pregnancy test at screening.
All patients of childbearing potential must be willing to consent to using effective contraception, i.e., IUD, Birth control pills, Depo-Provera, and/or condoms while on treatment and for 3 months after their last Gemcitabine/Docetaxel treatment.
No intravesical or upper tract topical therapy within 8 weeks of study entry.
Must be willing and able to comply with all protocol requirements.
Should have a Complete Blood Count (CBC) with differential before the index tumor resection or biopsy (within 30 days) and/or within 14 days before starting Gemcitabine/Docetaxel therapy.
Must be willing and able to give informed consent and any authorizations required by the local Institutional Review Board (IRB) for participation in this study.

Exclusion

History or concurrent Stage T2 or greater urothelial cancer.
History or concurrent upper tract or prostatic urethral cancer (no suspicious or positive upper tract cytology and negative upper tract imaging within 6 months of study entry; visually normal or absent prostatic urethra by cystoscopy).
History or concurrent variant bladder cancer histology including squamous cell carcinoma, adenocarcinoma, small cell carcinoma, plasmacytoid carcinoma, nested urothelial carcinoma, sarcomatoid carcinoma, squamous, glandular, metastatic carcinoma and others. Select urothelial carcinoma with favorable micropapillary differentiation is permitted (see above).
Active other malignancies excluding indolent or well-controlled prostate cancer, basal or squamous cell skin cancers or non-invasive cancer of the cervix are permitted so long as they are not expected to impact 3-year survival outcomes.
History of severe hypersensitivity reaction (\>= grade 3) to Gemcitabine and/or Docetaxel.
History of severe hypersensitivity reaction (\>= grade 3) to Polysorbate 80 containing drugs (Docetaxel is formulated with Polysorbate 80)
Concurrent treatment with any intravesical or systemic chemotherapeutic agent (8-week washout required).
Treatment with a checkpoint inhibitor within 2 treatment cycles of enrollment.
Major surgery within 3 months of enrollment.
Inadequate organ and bone marrow function as evidenced by:
History of radiation to the pelvis.
History of difficult catheterization that in the opinion of the Investigator will prevent safe and/or reliable administration of the intravesical agents.
History of interstitial cystitis or current inability to hold \~ 2 ounces of fluid in the bladder for the expected 60-minute retention time (assistive medication and/or techniques (gravity reflux; split dosing) are permitted).
Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy (3- week documented clearance required).
Known human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C infection.
Recent Covid infection within 30 days of enrollment or currently symptomatic of Covid-related illnesses.
Significant cardiovascular risk (e.g., coronary stenting within 8 weeks, myocardial infarction within 6 months).
Women who are pregnant or lactating.
Participation in any other research protocol involving administration of an investigational agent within 6 weeks of study entry (8-week washout required)
Any other major or unstable medical condition that in the Investigator's opinion, could affect patient performance status, ability to receive the intravesical therapy and/or life expectancy during the five years of intended study participation.

What this trial measures

  • Efficacy of Intravesical Gemcitabine/Docetaxel in BCG-Unresponsive Carcinoma In Situ NMIBC3 months

    To determine the efficacy of intravesical Gemcitabine/Docetaxel in patients with BCG-unresponsive carcinoma in situ (CIS) urothelial bladder carcinoma, as measured by the complete response (CR) rate (%) at approximately 3 months. CR will be determined through mandatory cystoscopy, urine cytology, and biopsy for those with CIS.

  • Efficacy of Intravesical Gemcitabine/Docetaxel in BCG-Unresponsive Papillary NMIBC3 months

    To determine the efficacy of intravesical Gemcitabine/Docetaxel in patients with BCG-unresponsive papillary urothelial bladder carcinoma, as measured by high-grade recurrence-free survival (HG RFS) rate (%) at approximately 3 months. Non-positive cytology and non-suspicious visual cystoscopic findings will determine lack of HG disease for subjects entering this study with papillary tumors (HG Ta T1).