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Anti-metabolites

Gemcitabine for Bladder Cancer

Phase 2
Recruiting
Led By Juan Chipollini, MD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status Grade 0-2
Patients with intermediate or high-risk non-muscle-invasive UC of the bladder and no previous BCG treatment
Must not have
Active malignancies other than the disease being treated under study
Subjects with concurrent upper urinary tract (i.e. ureter, renal pelvis) urothelial carcinoma of any stage
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to gain a better understanding of intravesical Gemcitabine chemotherapy for non-muscle invasive bladder cancer. It will assess the effectiveness of this treatment for those who can't access BCG or have failed BCG treatment.

Who is the study for?
This trial is for adults over 18 with intermediate or high-risk non-muscle invasive bladder cancer who haven't had BCG treatment. They must understand English or Spanish, agree to follow the study rules, and be available for its duration. Excluded are those allergic to Gemcitabine, pregnant or breastfeeding women, patients with advanced bladder cancer stages, other active cancers, certain psychiatric conditions or substance abuse issues.
What is being tested?
The trial studies how well Gemcitabine works as a chemotherapy given directly into the bladder (intravesical) for patients who can't receive BCG therapy or didn't respond to it. It aims to provide better insights on treating non-muscle invasive bladder cancer with this drug in a prospective patient group.
What are the potential side effects?
Potential side effects of intravesical Gemcitabine may include irritation in the bladder area, urinary symptoms like increased frequency and discomfort during urination, possible allergic reactions in sensitive individuals, and general side effects such as nausea and low blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
Select...
My bladder cancer is at an intermediate or high risk stage and I haven't had BCG treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any active cancer other than the one being treated in this study.
Select...
I have cancer in my upper urinary tract.
Select...
My bladder cancer is confirmed as a specific type by lab tests.
Select...
My bladder cancer is at least stage T2.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Complete response rate (CR) for treatment with intravesical gemcitabine for patients with intermediate and high-risk NMIBC
Secondary study objectives
Durability of response in patients who achieve CR
Proportion of patients who accept maintenance therapy
Rate and reasons for cystectomy (if any)
+1 more
Other study objectives
Specimen collection as part of standard of care for future exploratory research

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%
Dyspnoea
1%
Cerebral infarction
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)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Gemcitabine inductionExperimental Treatment1 Intervention
Patients will receive Gemcitabine once weekly for 6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~1920

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor
536 Previous Clinical Trials
159,705 Total Patients Enrolled
Juan Chipollini, MDPrincipal InvestigatorUniversity of Arizona

Media Library

Gemcitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT05644041 — Phase 2
Bladder Cancer Research Study Groups: Gemcitabine induction
Bladder Cancer Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT05644041 — Phase 2
Gemcitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05644041 — Phase 2
~2 spots leftby Jan 2025
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