A Randomized Study Comparing Single Agent Gemcitabine Intravesical Therapy Versus Mitomycin C in Patients With Intermediate Risk Superficial Bladder Cancer

Phase 2

Completed

• Conditions: Superficial Bladder Cancer

• Registration Number: NCT00192049
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Gemcitabine has been shown to be highly effective and well tolerated in the first and second line therapy, as a single agent or in combination therapy for treatment of metastatic transitional cell carcinoma. On the basis of Gemcitabine clinical activity and good tolerability this drug has been recently tested in intravesical therapy. we consider Gemcitabine as a good therapy candidate for patient with intermediate risk superficial bladder cancer. Based on the phase I/II clinical trials w are going to explore the efficacy and tolerability of Gemcitabine in this setting, and compare it to Mitomycin C which is widely used in this group of patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Study Completion: 2007-04
• Status Verified: 2007-05
• Last Update Submitted: 2007-05-16
• Last Update Posted: 2007-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Histologically verified superficial transitional cell carcinoma of the bladder.
• patients with primary or recurrent intermediate risk superficial bladder cancer after TUR. Patients with primary tumor with stage TaG1 with multiple lesions (>3) or lesions bigger than 3 cm or patients with TaG2-3 or T1G1-2.
• Patients must not be pre-treated with any intravesical immunotherapy (BCG) or chemotherapy.
• Male or female, age greater than 18.

Exclusion Criteria

• Time between TUR and start of intravesical chemotherapy will be longer than 4 weeks.
• Patients who have received previous (BCG) or chemotherapy.
• Patients with evidence of invasive, locally advanced or metastatic bladder cancer (greater than or equal to T2 disease; stage greater than or equal to B1) or patients with upper urinary tract disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Compare the tumor recurrence rate at 12 months after TUR in patients with intermediate risk superficial bladder cancer treated with intravesical Gemcitabine or Mitomycin C.

Secondary Outcome Measures

Name	Time	Method
Tumor recurrence rate in 6 months
disease free interval
Toxicity profile (local and systemic)

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician; 🇮🇱 Tel hashomer, Israel