Clinical trial NCT00192049: A Randomized Study Comparing Single Agent Gemcitabine Intravesical Therapy Versus Mitomycin C in Patients With Intermediate Risk Superficial Bladder Cancer
Official title: A Randomized Phase II Study Comparing Single Agent Gemcitabine Intravesical Therapy Versus Mitomycin C in Patients With Intermediate Risk Superficial Bladder Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Superficial Bladder Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
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.
Secondary outcomes:
measure: Tumor recurrence rate in 6 months
measure: disease free interval
measure: Toxicity profile (local and systemic)
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: 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
city: Haifa
country: Israel
facility: 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
city: Jerusalem
country: Israel
facility: 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
city: Kfar saba
country: Israel
facility: 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
city: Tel hashomer
country: Israel
facility: 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
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: Han MA, Maisch P, Jung JH, Hwang JE, Narayan V, Cleves A, Hwang EC, Dahm P. Intravesical gemcitabine for non-muscle invasive bladder cancer. Cochrane Database Syst Rev. 2021 Jun 14;6(6):CD009294. doi: 10.1002/14651858.CD009294.pub3.