- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00192049
A Randomized Study Comparing Single Agent Gemcitabine Intravesical Therapy Versus Mitomycin C in Patients With Intermediate Risk Superficial Bladder Cancer
May 16, 2007 updated by: Eli Lilly and Company
A Randomized Phase II Study Comparing Single Agent Gemcitabine Intravesical Therapy Versus Mitomycin C in Patients With Intermediate Risk Superficial Bladder Cancer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
90
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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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
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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
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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
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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
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Tel hashomer, 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
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Secondary Outcome Measures
Outcome Measure |
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Tumor recurrence rate in 6 months
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disease free interval
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Toxicity profile (local and systemic)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: 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), Eli Lilly and Company
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2003
Study Completion (Actual)
April 1, 2007
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 19, 2005
Study Record Updates
Last Update Posted (Estimate)
May 17, 2007
Last Update Submitted That Met QC Criteria
May 16, 2007
Last Verified
May 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Urinary Bladder Diseases
- Urinary Bladder Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Alkylating Agents
- Antibiotics, Antineoplastic
- Gemcitabine
- Mitomycins
- Mitomycin
Other Study ID Numbers
- 8048
- B9E-MC-S344
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Superficial Bladder Cancer
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University of SydneyAustralian and New Zealand Urogenital and Prostate Cancer Trials Group; Cancer... and other collaboratorsCompletedSuperficial Bladder CancerUnited States, Australia, New Zealand, Canada, United Kingdom
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University of Rome Tor VergataCompletedSuperficial Bladder CancerItaly
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Halozyme TherapeuticsCompletedSuperficial Bladder CancerUnited States
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Anchiano Therapeutics Israel Ltd.CompletedSuperficial Bladder CancerIsrael, United States
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North Florida/South Georgia Veterans Health SystemAxcan Pharma; North Florida Foundation for Research and EducationCompletedSuperficial Bladder CancerUnited States
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Eli Lilly and CompanyCompleted
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FKD Therapies OyCompletedSuperficial Bladder Cancer
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Abnoba GmbhCompletedSuperficial Bladder CancerEgypt, Germany
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Mansoura UniversityCompletedCarcinoma of Urinary Bladder, SuperficialEgypt
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National University Hospital, SingaporeNational Medical Research Council (NMRC), SingaporeCompletedCarcinoma of Urinary Bladder, SuperficialSingapore
Clinical Trials on Gemcitabine
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Sierra Oncology LLC - a GSK companyCompletedAdvanced Solid TumorsSpain, United Kingdom
-
University of Erlangen-Nürnberg Medical SchoolCompleted
-
Shenzhen University General HospitalNot yet recruiting
-
3D Medicines (Sichuan) Co., Ltd.Not yet recruitingBiliary Tract Neoplasms
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Kansai Hepatobiliary Oncology GroupCompleted
-
Fifth Affiliated Hospital, Sun Yat-Sen UniversityRecruiting
-
3D Medicines (Sichuan) Co., Ltd.RecruitingBiliary Tract NeoplasmsChina
-
Yung NAQueen Mary Hospital, Hong Kong; Pamela Youde Nethersole Eastern HospitalRecruitingMuscle-Invasive Bladder Carcinoma | Muscle Invasive Bladder Urothelial CarcinomaHong Kong
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Air Force Military Medical University, ChinaRecruiting