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


Phase 2
18 Years
N/A
Not Enrolling
Both
Superficial Bladder Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon -Fri 9 AM-5 PM Eastern time (UTC/GMT - 5 hours,EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:

8048

NCT ID:

NCT00192049

Start Date:

December 2003

Completion Date:

April 2007

Related Keywords:

  • Superficial Bladder Cancer
  • Urinary Bladder Neoplasms

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