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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00192049
Other study ID # 8048
Secondary ID B9E-MC-S344
Status Completed
Phase Phase 2
First received September 12, 2005
Last updated May 16, 2007
Start date December 2003
Est. completion date April 2007

Study information

Verified date May 2007
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial 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.


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Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Gemcitabine

mitomycin C


Locations

Country Name City State
Israel 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 Beer Sheva
Israel 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 Haifa
Israel 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 Jerusalem
Israel 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 Kfar saba
Israel 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

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Tumor recurrence rate in 6 months
Secondary disease free interval
Secondary Toxicity profile (local and systemic)
See also
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Completed NCT00782587 - Study of Immediate Post-Operative Intravesical Instillation of Chemophase® in Patients With Superficial Bladder Cancer Phase 1
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Recruiting NCT03121768 - A New Prognostic Model for Predicting the Outcome of Patients With Non-muscle Invasive Bladder Cancer (NMIBC) N/A
Completed NCT03091764 - Evaluation of a Patient-Reported Symptom Index for NMIBC
Completed NCT01939756 - Intravesical Natural Baobab Oil in the Management of BCG-induced Lower Urinary Tract Symptoms Phase 1/Phase 2
Completed NCT00595088 - Phase 2b, Trial of Intravesical DTA-H19/PEI in Patients With Intermediate-Risk Superficial Bladder Cancer Phase 2
Completed NCT02007005 - Maximum Tolerable Concentration of abnobaVISCUM Fraxini Intravesically in Patients With Superficial Bladder Cancer Phase 1/Phase 2
Completed NCT01149174 - Preoperative Intravesical Electromotive Mitomycin-c for Primary Non-muscle Invasive Bladder Cancer Phase 3
Completed NCT00322699 - Sequential Whole Bladder Photodynamic Therapy (WBPDT) in the Management of Superficial Bladder Cancer Phase 1/Phase 2
Completed NCT00191711 - Intravesical Gemcitabine Instillation Followed by Transurethral Resection for the Treatment of Patients With Superficial Bladder Cancer at Low Risk. Phase 2
Recruiting NCT04752722 - LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve Phase 1/Phase 2
Recruiting NCT02106572 - Therapeutic Instillation of Mistletoe Phase 3
Completed NCT00734994 - Mitomycin C With Hyperthermia and Intravesical Mitomycin C to Treat Recurrent Bladder Cancer Phase 0

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