Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00234039
Status:
COMPLETED
Last Update Posted:
2016-01-08
First Post:
2005-10-05
Brief Title:
S0353 Gemcitabine in Treating Patients With Recurrent Bladder Cancer That Has Not Responded to Previous Bacillus Calmette-Guerin
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Phase II Study of Intravesical Gemcitabine in Patients With Superficial Bladder Cancer Who Have Progressed Despite Intravesical BCG
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
OBJECTIVES
Determine the 8-12 week efficacy of intravesical gemcitabine in terms of complete response rate in patients with recurrent superficial transitional cell carcinoma of the bladder that have progressed despite prior intravesical Bacillus Calmette-Guerin BCG
Determine the recurrence-free worsening-free progression-free and overall survival of patients treated with this drug
Evaluate the toxicity of this drug in these patients
Correlate preliminarily expression levels of genes or genetic polymorphisms involved in the gemcitabine pathway and angiogenesis with clinical toxicity response and relapse-free survival of patients treated with this drug
OUTLINE This is a multicenter study
Induction therapy Patients receive gemcitabine intravesically once a week for 6 weeks weeks 1-6 in the absence of disease progression or unacceptable toxicity Patients achieving a complete response proceed to maintenance therapy at week 14
Maintenance therapy Patients receive gemcitabine intravesically once in weeks 14 18 22 26 30 34 38 42 46 and 50 in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 25-45 patients will be accrued for this study within 6-12 months
Determine the 8-12 week efficacy of intravesical gemcitabine in terms of complete response rate in patients with recurrent superficial transitional cell carcinoma of the bladder that have progressed despite prior intravesical Bacillus Calmette-Guerin BCG
Determine the recurrence-free worsening-free progression-free and overall survival of patients treated with this drug
Evaluate the toxicity of this drug in these patients
Correlate preliminarily expression levels of genes or genetic polymorphisms involved in the gemcitabine pathway and angiogenesis with clinical toxicity response and relapse-free survival of patients treated with this drug
OUTLINE This is a multicenter study
Induction therapy Patients receive gemcitabine intravesically once a week for 6 weeks weeks 1-6 in the absence of disease progression or unacceptable toxicity Patients achieving a complete response proceed to maintenance therapy at week 14
Maintenance therapy Patients receive gemcitabine intravesically once in weeks 14 18 22 26 30 34 38 42 46 and 50 in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 25-45 patients will be accrued for this study within 6-12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA032102 | NIH | None | None |
| S0353 | OTHER | SWOG | httpsreporternihgovquickSearchU10CA032102 |