Urothelial Carcinoma BladderPhase 2GEMDOCENCT04386746
Intravesical Gemcitabine and Docetaxel for BCG naïve Non-muscle Invasive Bladder Cancer
A Phase 2 study testing Gemcitabine and Docetaxel in people with Urothelial Carcinoma Bladder and Bladder Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
A single-arm, two-stage, open-label, phase 2 study investigating the safety and efficacy of intravesical gemcitabine/docetaxel for bacillus Calmette-Guerin (BCG)-naïve patients with non-muscle invasive bladder cancer (NMIBC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma Bladder, Bladder Cancer
- What is being tested?
- Gemcitabine and Docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2020to 30 Nov 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed intermediate or high-risk non-muscle invasive urothelial carcinoma of the bladder (Ta, T1, or Tis stage) on TURBT obtained within 90 days of registration defined according to modified EORTC risk criteria summarized as follows:
- Low-risk tumors: Initial or recurrent tumor > 12 months after resection with all of the following:
- Solitary tumor
- Low-grade
- < 3 cm
- No carcinoma in situ (CIS)
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- Intermediate-risk tumors: All tumors not defined in the two adjacent categories (between the category of low- and high-risk)
- High-risk tumors: Any of the following:
- T1 tumor
- High-grade
- CIS
- Multiple and recurrent and large (> 3 cm) Ta low-grade tumors (all conditions must be met for this point of Ta low-grade tumors)
- Note #1: Low-risk tumors as defined above are not eligible
- Note #2: Mixed histologies are permitted, provided a component of urothelial carcinoma is present
- Note #3: All patients with high-grade T1 (HGT1) should undergo a restaging TURBT
- Eastern Cooperative Oncology Group (ECOG) (WHO) performance status 0, 1, or 2
- Age ≥ 18 years old at time of consent
- Evidence of post-menopausal status or negative urinary or serum pregnancy test or 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. The following age-specific requirements apply:
- Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
- Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
- Subjects who give a written informed consent obtained according to local guidelines.
Who cannot join
- Subjects with muscle-invasive (i.e. T2, T3, T4), locally advanced unresectable, or metastatic urothelial carcinoma as assessed on baseline radiographic imaging obtained within 90 days prior to study registration. The required radiographic imaging includes:
- Abdomen/Pelvis - CT scan
- Chest - chest x-ray or CT scan
- Subjects with concurrent upper urinary tract (i.e. ureter, renal pelvis) urothelial carcinoma of any stage.
- Note: Subjects with history of non-invasive (Ta, Tis) upper tract urothelial carcinoma that has been definitively treated with at least one post-treatment disease assessment (i.e. cytology, biopsy, imaging) that demonstrates no evidence of residual disease are eligible.
- Subjects with another active second malignancy with an estimated overall survival from the second malignancy of < 12 months. Subjects with another second active malignancy that are deemed to have an estimated overall survival of >12 months are eligible.
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- Subjects who have received the last administration of an anti-cancer therapy including chemotherapy, immunotherapy, and monoclonal antibodies ≤ 4 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy.
- Subjects who have had radiotherapy ≤ 4 weeks prior to starting study drug, or who have not recovered from radiotherapy toxicities.
- Pregnant or breast-feeding women.
- Subjects unwilling or unable to comply with the protocol.
- Patients with prior systemic gemcitabine or docetaxel use for a non-bladder malignancy may enroll and receive treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University: Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287
About this study
Official title: A Phase II Trial for the Use of Intravesical Gemcitabine and Docetaxel (GEMDOCE) in the Treatment of BCG naïve Non-muscle Invasive Urothelial Carcinoma of the Bladder
A single-arm, two-stage, open-label, phase 2 study investigating the safety and efficacy of intravesical gemcitabine/docetaxel for bacillus Calmette-Guerin (BCG)-naïve patients with non-muscle invasive bladder cancer (NMIBC).
Read the detailed description
All participants will receive an induction course of gemcitabine/docetaxel instillations (administered once a week for six consecutive weeks) followed by monthly maintenance instillations if initial efficacy is seen. In addition to providing initial efficacy data, this study will provide safety and long-term efficacy data on the combination regimen studied. A tolerable safety profile and demonstrated efficacy would support a potential, randomized phase 3 trial comparing the experimental combination therapy and standard of care intravesical BCG therapy.
- Conditions
- Urothelial Carcinoma Bladder, Bladder Cancer
- Being tested
- Gemcitabine, Docetaxel
- Keywords
- NMIBC
- Medical subject headings
- Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemzar
1g gemcitabine in 50ml sterile water; instilled once weekly for 6 weeks and then once monthly for ≤ 21 months.
DocetaxelDrug
Also called Taxotere
37.5mg docetaxel in 50ml normal saline solution (NSS); instilled once weekly for 6 weeks and then once monthly for ≤ 21 months.
| Study group | Role | What they receive |
|---|---|---|
| Intravesical Gemcitabine/Docetaxel | Experimental | Gemcitabine/Docetaxel induction is given intravesically in sequential order once a week for six consecutive weeks. One gram of gemcitabine in 50 ml of sterile water is slowly instilled into the bladder via a Foley catheter and the catheter is clamped for 60 minutes. The bladder is then drained and 40 mg of docetaxel in 50 ml of NSS is then slowly instilled via the Foley catheter into the bladder. The catheter is again clamped for 60 minutes before draining. If initial efficacy seen, patients will have monthly maintenance instillations of Gemcitabine/Docetaxel. Receives: Drug: Gemcitabine; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-Month Complete Response Rate
Number of patients with no evidence of recurrent high grade urothelial carcinoma of the bladder of any stage as assessed by cystoscopy with biopsy and urine cytology.
Measured: 3 months
Secondary outcomes (24)
12-Month Relapse-Free Survival Rate
Proportion of patients alive and with no evidence of recurrent high grade urothelial carcinoma of the bladder of any stage.
Measured: 12 months
24-Month Relapse-Free Survival Rate
Proportion of patients alive and with no evidence of recurrent high grade urothelial carcinoma of the bladder of any stage.
Measured: 24 months
Safety Profile as Assessed by Proportion of Adverse Events by Type
Proportion of adverse events by type, as defined by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Measured: Up to 24 months
Safety Profile as Assessed by Proportion of Adverse Events by Grade
Proportion of adverse events by grade, as defined by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Measured: Up to 24 months
Number of Gene Alterations as Measured by RNA-seq
Number of gene alterations as measured by RNA-seq. Compare results to 3-month Complete Response rate using statistical methods.
Measured: 3 months
Type of Gene Alterations as Measured by RNA-seq
Type of gene alterations as measured by RNA-seq. Compare results to 3-month Complete Response rate using statistical methods.
Measured: 3 months
Number of Gene Alterations as Measured by RNA-seq
Number of gene alterations as measured by RNA-seq. Compare results to 12-month Relapse-Free Survival rate using statistical methods.
Measured: 12 months
Type of Gene Alterations as Measured by RNA-seq
Type of gene alterations as measured by RNA-seq. Compare results to 12-month Relapse-Free Survival rate using statistical methods.
Measured: 12 months
Number of DNA Mutations as Measured by Whole Transcriptome
Number of DNA mutations as measured by whole transcriptome. Compare results to 3-month Complete Response rate.
Measured: 3 months
Number of DNA Mutations as Measured by Whole Exome
Number of DNA mutations as measured by whole exome. Compare results to 3-month Complete Response rate.
Measured: 3 months
Number of DNA Mutations as Measured by Panel DNA Sequencing
Number of DNA mutations as measured by panel DNA sequencing. Compare results to 3-month Complete Response rate.
Measured: 3 months
Type of DNA Mutations as Measured by Whole Transcriptome
Type of DNA mutations as measured by whole transcriptome. Compare results to 3-month Complete Response rate.
Measured: 3 months
Type of DNA Mutations as Measured by Whole Exome
Type of DNA mutations as measured by whole exome. Compare results to 3-month Complete Response rate.
Measured: 3 months
Type of DNA Mutations as Measured by Panel DNA Sequencing
Type of DNA mutations as measured by panel DNA sequencing. Compare results to 3-month Complete Response rate.
Measured: 3 months
Number of DNA Mutations as Measured by Whole Transcriptome
Number of DNA mutations as measured by whole transcriptome. Compare results to 12-month Relapse Free Survival rate using statistical analysis.
Measured: 12 months
Number of DNA Mutations as Measured by Whole Exome
Number of DNA mutations as measured by whole exome. Compare results to 12-month Relapse Free Survival rate using statistical analysis.
Measured: 12 months
Number of DNA Mutations as Measured by Panel DNA Sequencing
Number of DNA mutations as measured by panel DNA sequencing. Compare results to 12-month Relapse Free Survival rate using statistical analysis.
Measured: 12 months
Type of DNA Mutations as Measured by Whole Transcriptome
Type of DNA mutations as measured by whole transcriptome. Compare results to 12-month Relapse Free Survival rate using statistical analysis.
Measured: 12 months
Type of DNA Mutations as Measured by Whole Exome
Type of DNA mutations as measured by whole exome. Compare results to 12-month Relapse Free Survival rate using statistical analysis.
Measured: 12 months
Type of DNA Mutations as Measured by Panel DNA Sequencing
Type of DNA mutations as measured by panel DNA sequencing. Compare results to 12-month Relapse Free Survival rate using statistical analysis.
Measured: 12 months
Numbers of T-cell Subpopulations
Numbers of t-cell subpopulations utilizing immunohistochemical (IHC) staining and flow cytometry. Compare results to 3-month Complete Response rate using statistical analysis.
Measured: 3 months
Ratio of T-cell Subpopulations
Ratio of t-cell subpopulations utilizing IHC staining and flow cytometry. Compare results to 3-month Complete Response rate using statistical analysis.
Measured: 3 months
Numbers of T-cell Subpopulations
Numbers of t-cell subpopulations utilizing IHC staining and flow cytometry. Compare results to 12-month Relapse-Free Survival rate using statistical analysis.
Measured: 12-months
Ratio of T-cell Subpopulations
Ratio of t-cell subpopulations utilizing IHC staining and flow cytometry. Compare results to 12-month Relapse-Free Survival rate using statistical analysis.
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start29 Jul 2020
- Primary completion4 Oct 2022
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urothelial Carcinoma BladderStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Max Kates, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386746
- Sponsor's protocol ID
- J2020
- Other IDs
- IRB00241941
- Acronym
- GEMDOCE
- Status last verified
- Nov 2025
- First submitted
- 8 May 2020
- Last updated
- 17 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial for the Use of Intravesical Gemcitabine and Docetaxel (GEMDOCE) in the Treatment of BCG naïve Non-muscle Invasive Urothelial Carcinoma of the Bladder
- ClinicalTrials.gov ID
- NCT04386746
- Acronym / sponsor ID
- GEMDOCE / J2020
- Conditions
- Urothelial Carcinoma Bladder, Bladder Cancer
- Keywords
- NMIBC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- 4 Oct 2022 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 13 May 2020 (actual)
- Results
- Posted 13 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single-arm, two-stage, open-label, phase 2 study investigating the safety and efficacy of intravesical gemcitabine/docetaxel for bacillus Calmette-Guerin (BCG)-naïve patients with non-muscle invasive bladder cancer (NMIBC).
Detailed description
All participants will receive an induction course of gemcitabine/docetaxel instillations (administered once a week for six consecutive weeks) followed by monthly maintenance instillations if initial efficacy is seen. In addition to providing initial efficacy data, this study will provide safety and long-term efficacy data on the combination regimen studied. A tolerable safety profile and demonstrated efficacy would support a potential, randomized phase 3 trial comparing the experimental combination therapy and standard of care intravesical BCG therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravesical Gemcitabine/Docetaxel | Experimental | Drug: Gemcitabine, Drug: DocetaxelGemcitabine/Docetaxel induction is given intravesically in sequential order once a week for six consecutive weeks. One gram of gemcitabine in 50 ml of sterile water is slowly instilled into the bladder via a Foley catheter and the catheter is clamped for 60 minutes. The bladder is then drained and 40 mg of docetaxel in 50 ml of NSS is then slowly instilled via the Foley catheter into the bladder. The catheter is again clamped for 60 minutes before draining. If initial efficacy seen, patients will have monthly maintenance instillations of Gemcitabine/Docetaxel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Histologically confirmed intermediate or high-risk non-muscle invasive urothelial carcinoma of the bladder (Ta, T1, or Tis stage) on TURBT obtained within 90 days of registration defined according to modified EORTC risk criteria summarized as follows:
- Eastern Cooperative Oncology Group (ECOG) (WHO) performance status 0, 1, or 2
- Age ≥ 18 years old at time of consent
- Evidence of post-menopausal status or negative urinary or serum pregnancy test or 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. The following age-specific requirements apply:
- Subjects who give a written informed consent obtained according to local guidelines.
Key exclusion criteria (11 listed)
- Subjects with muscle-invasive (i.e. T2, T3, T4), locally advanced unresectable, or metastatic urothelial carcinoma as assessed on baseline radiographic imaging obtained within 90 days prior to study registration. The required radiographic imaging includes:
- Subjects with concurrent upper urinary tract (i.e. ureter, renal pelvis) urothelial carcinoma of any stage.
- Subjects with another active second malignancy with an estimated overall survival from the second malignancy of < 12 months. Subjects with another second active malignancy that are deemed to have an estimated overall survival of >12 months are eligible.
- Subjects who have received the last administration of an anti-cancer therapy including chemotherapy, immunotherapy, and monoclonal antibodies ≤ 4 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy.
- Subjects who have had radiotherapy ≤ 4 weeks prior to starting study drug, or who have not recovered from radiotherapy toxicities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GemcitabineAlso: Gemzar1g gemcitabine in 50ml sterile water; instilled once weekly for 6 weeks and then once monthly for ≤ 21 months. | Drug | Intravesical Gemcitabine/Docetaxel |
| DocetaxelAlso: Taxotere37.5mg docetaxel in 50ml normal saline solution (NSS); instilled once weekly for 6 weeks and then once monthly for ≤ 21 months. | Drug | Intravesical Gemcitabine/Docetaxel |
Primary outcome
3-Month Complete Response Rate
Time frame: 3 months
Number of patients with no evidence of recurrent high grade urothelial carcinoma of the bladder of any stage as assessed by cystoscopy with biopsy and urine cytology.
24 secondary outcomes
12-Month Relapse-Free Survival Rate
Time frame: 12 months
24-Month Relapse-Free Survival Rate
Time frame: 24 months
Safety Profile as Assessed by Proportion of Adverse Events by Type
Time frame: Up to 24 months
Safety Profile as Assessed by Proportion of Adverse Events by Grade
Time frame: Up to 24 months
Number of Gene Alterations as Measured by RNA-seq
Time frame: 3 months
Type of Gene Alterations as Measured by RNA-seq
Time frame: 3 months
Number of Gene Alterations as Measured by RNA-seq
Time frame: 12 months
Type of Gene Alterations as Measured by RNA-seq
Time frame: 12 months
Number of DNA Mutations as Measured by Whole Transcriptome
Time frame: 3 months
Number of DNA Mutations as Measured by Whole Exome
Time frame: 3 months
Number of DNA Mutations as Measured by Panel DNA Sequencing
Time frame: 3 months
Type of DNA Mutations as Measured by Whole Transcriptome
Time frame: 3 months
Type of DNA Mutations as Measured by Whole Exome
Time frame: 3 months
Type of DNA Mutations as Measured by Panel DNA Sequencing
Time frame: 3 months
Number of DNA Mutations as Measured by Whole Transcriptome
Time frame: 12 months
Number of DNA Mutations as Measured by Whole Exome
Time frame: 12 months
Number of DNA Mutations as Measured by Panel DNA Sequencing
Time frame: 12 months
Type of DNA Mutations as Measured by Whole Transcriptome
Time frame: 12 months
Type of DNA Mutations as Measured by Whole Exome
Time frame: 12 months
Type of DNA Mutations as Measured by Panel DNA Sequencing
Time frame: 12 months
Numbers of T-cell Subpopulations
Time frame: 3 months
Ratio of T-cell Subpopulations
Time frame: 3 months
Numbers of T-cell Subpopulations
Time frame: 12-months
Ratio of T-cell Subpopulations
Time frame: 12-months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Max Kates, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine and Docetaxel in people with Urothelial Carcinoma Bladder and Bladder Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-Month Complete Response Rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.