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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Complete response rate (CR) for treatment with intravesical gemcitabine for patients with intermediate and high-risk NMIBC

Secondary outcome measures

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 outcome measures

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

Blood sodium decreased

Hypokalaemia

Insomnia

Pyrexia

Hyponatraemia

Blood creatinine increased

Lymphopenia

Diarrhoea

Dyspepsia

Red blood cell count decreased

Cough

Dizziness

Bone marrow failure

Ischaemic stroke

Cerebral infarction

Dyspnoea

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Gemcitabine Plus Cisplatin (GC)

Pemetrexed Plus Cisplatin (PC)

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

~2070

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor

514 Previous Clinical Trials

148,569 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

Frequently Asked Questions

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

Has the FDA authorized Gemcitabine induction for medical use?

"The safety metrics of gemcitabine induction have been assessed to be a 2 on our team's scale, as Phase 2 trials are indicative that the drug has some evidence behind it in regards to its security but not necessarily efficacy."

Answered by AI

Are investigators currently looking for participants to join this research?

"The data available on clinicaltrials.gov suggests that this particular trial is no longer searching for participants, as its last update was made on December 21st of 2022. However, there are 318 other medical trials actively recruiting at the present moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intravesical Gemcitabine in Patients With NMIBC

2023. "Intravesical Gemcitabine in Patients With NMIBC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05644041.