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Anti-tumor antibiotic

Gemcitabine + Docetaxel for Bladder Cancer (GEMDOCE Trial)

Phase 2
Waitlist Available
Led By Max Kates, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Evidence of post-menopausal status or negative urinary or serum pregnancy test or female pre-menopausal patients is required
Eastern Cooperative Oncology Group (ECOG) (WHO) performance status 0, 1, or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

GEMDOCE Trial Summary

This trial is testing a new combination therapy for bladder cancer that has not yet been proven safe or effective. If the new therapy is found to be both safe and effective, it could become the new standard of care.

Who is the study for?
This trial is for adults with early-stage bladder cancer that hasn't spread into the muscle. They should be in fairly good health, not pregnant or breastfeeding, and haven't had certain cancer treatments recently. People with more advanced cancer, another serious active cancer, or those who've used gemcitabine or docetaxel for other cancers can't join.Check my eligibility
What is being tested?
The study tests a combination of two drugs, Gemcitabine and Docetaxel, given directly into the bladder to treat patients who have never received BCG therapy. It's an open-label phase 2 study which means everyone gets the treatment and researchers track its safety and effectiveness.See study design
What are the potential side effects?
Potential side effects may include irritation inside the bladder, urinary symptoms like increased frequency or discomfort when urinating, allergic reactions to medications used, as well as possible blood disorders.

GEMDOCE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am post-menopausal or not pregnant.
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I am able to care for myself and perform daily activities.
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My bladder cancer is confirmed and not yet invasive.
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I am 18 years old or older.

GEMDOCE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
3-Month Complete Response Rate
Secondary outcome measures
12-Month Relapse-Free Survival Rate
24-Month Relapse-Free Survival Rate
Safety Profile as Assessed by Proportion of Adverse Events by Grade
+1 more
Other outcome measures
Number of DNA Mutations as Measured by Panel DNA Sequencing
Number of DNA Mutations as Measured by Whole Exome
Number of DNA Mutations as Measured by Whole Transcriptome
+7 more

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680
51%
Neutropenia
47%
Leukopenia
46%
Nausea
43%
Vomiting
35%
Anaemia
31%
Decreased appetite
26%
Haemoglobin decreased
26%
Fatigue
25%
Constipation
25%
White blood cell count decreased
24%
Neutrophil count decreased
19%
Alanine aminotransferase increased
13%
Platelet count decreased
12%
Rash
10%
Aspartate aminotransferase increased
10%
Thrombocytopenia
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Ischaemic stroke
1%
Cerebral infarction
1%
Dyspnoea
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)

GEMDOCE Trial Design

1Treatment groups
Experimental Treatment
Group I: Intravesical Gemcitabine/DocetaxelExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
FDA approved
Gemcitabine
FDA approved

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
554 Previous Clinical Trials
32,884 Total Patients Enrolled
Max Kates, MDPrincipal InvestigatorJohns Hopkins University

Media Library

Docetaxel (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04386746 — Phase 2
Bladder Cancer Research Study Groups: Intravesical Gemcitabine/Docetaxel
Bladder Cancer Clinical Trial 2023: Docetaxel Highlights & Side Effects. Trial Name: NCT04386746 — Phase 2
Docetaxel (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04386746 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we currently looking for new participants in this experiment?

"According to the most recent update on clinicaltrials.gov, this trial is no longer looking for patients. The study was first posted on 7/29/2020 but has not been updated since 8/18/2022. Although this particular trial has completed recruitment, there are 3623 other trials that are still enrolling patients."

Answered by AI

Is Gemcitabine a drug with few adverse effects?

"While there is some evidence of Gemcitabine's safety, it did not receive a score higher than 2 because this is only a Phase 2 trial."

Answered by AI

How many patients are enrolled in this clinical trial?

"Currently, this clinical trial is not accepting new patients. The original posting was on 7/29/2020 with the most recent update being made on 8/18/2022. If you are looking for other trials, there are 2865 active studies searching for patients with carcinoma and 758 trials actively enrolling patients that focus on Gemcitabine."

Answered by AI

What conditions does Gemcitabine typically alleviate?

"Gemcitabine can be used to treat neoplasm metastasis, metastatic bladder cancer, and patients with advance directives."

Answered by AI

What is the research history of Gemcitabine?

"There are 758 ongoing studies and 255 in Phase 3 that involve Gemcitabine. The research is being conducted all over the world with 42911 different trial locations, although a significant portion of the work is happening in Shanghai, China."

Answered by AI
~6 spots leftby Mar 2025