NCT00003129

Chemotherapy in Treating Patients With Early-Stage Bladder Cancer

Phase II Study of Intravesical Therapy With AD 32 in Patients With Papillary Urothelial Carcinoma or Carcinoma in Situ (CIS) Refractory to Prior Therapy With Bacillus Calmette-Guerin

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Eastern Cooperative Oncology Group · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of chemotherapy in treating patients with early-stage bladder cancer that has not responded to BCG therapy.

Detailed description

OBJECTIVES: * Determine the recurrence rate and disease free survival in patients with recurrent or refractory papillary transitional cell carcinoma of the bladder with or without carcinoma in situ of the bladder treated with intravesical AD 32. * Evaluate the safety of administering this drug in these patients. * Determine the effectiveness of this drug, in terms of recurrence rates and disease free survival, in these patients. OUTLINE: Patients are stratified according to cellular diagnosis (papillary transitional cell carcinoma (Ta/T1) with no carcinoma in situ (Tis) vs Tis with or without Ta/T1). Patients receive intravesical AD 32 once a week for 6 weeks. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	valrubicin

Timeline

• Start date: 1998-09-01
• Primary completion: 2002-11-01
• Completion: 2009-05-01
• First posted: 2003-04-18
• Last updated: 2023-06-22

Locations

10 sites across 1 country: United States