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Anti-metabolites

Intravesical Gemcitabine for Bladder Cancer

Phase 2
Waitlist Available
Research Sponsored by Southwest Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine directly into the bladder may kill more tumor cells. PURPOSE: This phase II trial is studying how well gemcitabine works in treating patients with recurrent bladder cancer that has progressed despite previous Bacillus Calmette-Guerin (BCG).

Eligible Conditions
  • Bladder Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 at the End of Induction
Secondary study objectives
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Overall Survival (OS)
Recurrence-free Survival (RFS)

Side effects data

From 2019 Phase 1 & 2 trial • 26 Patients • NCT01535924
100%
White blood cell decreased
100%
Anemia
100%
Lymphocyte count decreased
67%
Platelet count decreased
67%
Vomiting
67%
Nausea
67%
Hyperglycemia
67%
Neutrophil count decreased
33%
Hyperhidrosis
33%
Dyspnea
33%
Sinusitis
33%
Abdominal Pain
33%
Alanine aminotransferase increased
33%
Constipation
33%
Dysgeusia
33%
Edema face
33%
Fatigue
33%
Hematoma
33%
Productive cough
33%
Pruritus
33%
Rash maculo-papular
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1 (Dose Levels 3)
Phase 1 (Dose Levels 4)
Phase 2 (Dose Levels 5)
Phase 2
Phase 1 (Dose Levels 1)
Phase 1 (Dose Levels 2)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Intravesical GemcitabineExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
FDA approved

Find a Location

Who is running the clinical trial?

Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
261,129 Total Patients Enrolled
SWOG Cancer Research NetworkLead Sponsor
395 Previous Clinical Trials
265,016 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,942 Total Patients Enrolled
~3 spots leftby Sep 2025
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