S0353, Gemcitabine in Treating Patients With Recurrent Bladder Cancer That Has Not Responded to Previous Bacillus Calmette-Guerin
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).
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Intravesical Gemcitabine in Patients With Superficial Bladder Cancer Who Have Progressed Despite Intravesical BCG|
- Complete Response Rate at the End of Induction [ Time Frame: Week 8-12, then every 3 months for the first 2 years, and then every 6 months for the years 3-5 ] [ Designated as safety issue: No ]Complete Response is defined as negative cystoscopy with negative biopsy and no evidence of cancer on urine cytology at the Week 8 - 12 cystoscopy
- Overall Survival (OS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]Measured from the day of registration to death due to any cause. Survival is censored at date of last contact.
- Recurrence-free Survival (RFS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]Recurrence-free Survival is defined as time from registration to first instance of disease recurrence, or death due to any cause.
- Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug [ Time Frame: Patients were assessed for adverse events weekly for 6 weeks and then every 4 weeks for 40 weeks ] [ Designated as safety issue: Yes ]Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
|Study Start Date:||November 2006|
|Estimated Study Completion Date:||February 2014|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
- 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.