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Anti-metabolites
S0353, Gemcitabine in Treating Patients With Recurrent Bladder Cancer That Has Not Responded to Previous Bacillus Calmette-Guerin
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
Approved for 10 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
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 • NCT01535924100%
White blood cell decreased
100%
Anemia
100%
Lymphocyte count decreased
67%
Vomiting
67%
Platelet count decreased
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)
Awards & Highlights
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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: 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
260,143 Total Patients Enrolled
SWOG Cancer Research NetworkLead Sponsor
398 Previous Clinical Trials
265,558 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,179 Total Patients Enrolled