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Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC

ConditionsBladder CancerNon-Muscle Invasive Bladder Cancer (NMIBC)Urothelial CarcinomaCarcinoma in Situ (CIS)High-Grade Papillary Bladder TumorsBCG-Unresponsive Bladder CancerTa Stage Bladder CancerT1 Stage Bladder CancerBCG-Refractory Bladder CancerHigh-Risk NMIBCMicropapillary Variant Urothelial Carcinoma (Favorable Subtype)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorMichael A. O'Donnell

About this trial

The goal of this clinical trial is to learn whether a combination of two chemotherapy drugs, Gemcitabine and Docetaxel, can treat high-grade non-muscle-invasive bladder cancer (HG-NMIBC) in adults whose cancer failed conventional BCG therapy. The drugs are given directly into the bladder (intravesically), one immediately after the other.

The study will also assess the safety of this treatment.

The main questions it aims to answer are:

Can this drug combination effectively treat HG-NMIBC that did not respond to BCG and help prevent the cancer from coming back, offering long-term protection? What side effects or medical issues do participants experience during treatment?

Researchers will evaluate this non-surgical approach as a potential alternative to bladder removal surgery (radical cystectomy), with the goal of validating it as a bladder-sparing option in this setting.

Participants will:

* Go through a screening process, including tumor removal and imaging tests * Receive weekly bladder treatments with Gemcitabine followed by Docetaxel for 6 weeks * If the cancer responds, continue with similar once monthly treatments (maintenance therapy) for up to 2 years * Attend regular check-ups, including bladder exams, urine tests, biopsies, and optional quality-of-life surveys * Possibly receive a second 6-week treatment cycle if the cancer returns early * Be followed for up to 5 years to monitor long-term outcomes

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intravesical Gemcitabine and Docetaxel

    Drug

    Sequential intravesical administration of Gemcitabine (1000mg) followed by Docetaxel (37 mg), delivered via sterile urethral catheter. Each drug is retained in the bladder for 60 minutes per instillation. The treatment consists of a 6-week induction phase (weekly instillations), followed by a 24-month maintenance phase (monthly instillations). This regimen is designed for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), including carcinoma in situ (CIS) and high-grade papillary tumors (Ta/T1). The study evaluates efficacy, tolerability, and bladder preservation outcomes.

Treatment groups

174 Participants
are divided into 2 treatment groups
Group A: Arm AExperimental treatment 1 intervention
Group B: Arm BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Efficacy of Intravesical Gemcitabine/Docetaxel in BCG-Unresponsive Carcinoma In Situ NMIBC

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.

Time frame
3 months
2

Efficacy of Intravesical Gemcitabine/Docetaxel in BCG-Unresponsive Papillary NMIBC

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).

Time frame
3 months

Secondary outcomes

1

Long-Term Efficacy of Intravesical Sequential Gemcitabine/Docetaxel in BCG-Unresponsive NMIBC

To assess duration of complete response for CIS +/- papillary TaT1 in month

Time frame
Up to 60 months (5 years) from initiation of treatment, with key evaluations at 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, and 60 months
2

Long-Term Efficacy of Intravesical Sequential Gemcitabine/Docetaxel in BCG-Unresponsive NMIBC

To assess high-grade recurrence-free survival (HGRFS) for HG papillary only TaT1 in month

Time frame
Up to 60 months (5 years) from initiation of treatment, with key evaluations at 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, and 60 months
3

Long-Term Efficacy of Intravesical Sequential Gemcitabine/Docetaxel in BCG-Unresponsive NMIBC

To assess recurrence-free survival (RFS) in month

Time frame
Up to 60 months (5 years) from initiation of treatment, with key evaluations at 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, and 60 months
4

Long Term Efficacy of Intravesical Sequential Gemcitabine/Docetaxel in BCG-Unresponsive NMIBC

To assess progression-free survival (PFS) in month

Time frame
Up to 60 months (5 years) from initiation of treatment, with key evaluations at 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, and 60 months

Other outcomes

1

Safety of Intravesical Sequential Gemcitabine/Docetaxel in BCG-Unresponsive NMIBC: Adverse Event Analysis

To assess the incidence (%) of adverse events

Time frame
Up to 60 months (5 years) from initiation of treatment, with key evaluations at 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, and 60 months
2

Safety of Intravesical Sequential Gemcitabine/Docetaxel in BCG-Unresponsive NMIBC: Adverse Event Analysis

To assess the severity of adverse events (Common Terminology Criteria for Adverse Events (CTCAE)) (Grade I-IV)

Time frame
Up to 60 months (5 years) from initiation of treatment, with key evaluations at 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, and 60 months
3

Change in Health-Related Quality of Life Measured by FACT-Bladder (FACT-Bl)

The Functional Assessment of Cancer Therapy-Bladder (FACT-Bl) is a validated, patient-reported outcome measure assessing health-related quality of life in bladder cancer. It includes the FACT-G core domains: Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), Functional Well-Being (FWB) plus a Bladder Cancer Subscale (BLCS). Score (range: 0-160). Higher scores indicate better quality of life.

Time frame
Up to 60 months (5 years), with assessments at baseline, Week 6 of induction, and at key evaluation points: 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, and 60 months.
4

Change in Health-Related Quality of Life Measured by FACT-General (FACT-G)

The Functional Assessment of Cancer Therapy-General (FACT-G) is a validated, oncology-generic patient-reported outcome covering Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Total Score Range: 0-108; higher scores indicate better quality of life.

Time frame
Up to 60 months (5 years), with assessments at baseline, Week 6 of induction, and at key evaluation points: 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, and 60 months.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Michael A. O'Donnell

Lead sponsor

University of Iowa

Sponsor institution

Source ClinicalTrials.gov
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