Superficial Bladder CancerPhase 2NCT00192049
A Randomized Study Comparing Single Agent Gemcitabine Intravesical Therapy Versus Mitomycin C in Patients With Intermediate Risk Superficial Bladder Cancer
A Phase 2 study testing Gemcitabine and mitomycin C in people with Superficial Bladder Cancer, run by Eli Lilly and Company at 5 sites in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Superficial Bladder Cancer
- What is being tested?
- Gemcitabine and mitomycin C
- How many people
- 90 participants
- Where
- 5 sitesIsrael
- Study dates
- Dec 2003to Apr 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Israel5 sites
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
Beersheba
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
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
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
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 Litwinsky
About this study
Official title: 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.
- Conditions
- Superficial Bladder Cancer
- Being tested
- Gemcitabine, mitomycin C
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
mitomycin CDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (3)
Tumor recurrence rate in 6 months
disease free interval
Toxicity profile (local and systemic)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startDec 2003
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Superficial Bladder CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192049
- Sponsor's protocol ID
- 8048
- Other IDs
- B9E-MC-S344
- Status last verified
- May 2007
- First submitted
- 12 Sep 2005
- Last updated
- 17 May 2007
- Results posted
- No
Publications
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.
PubMed 34125951
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study Comparing Single Agent Gemcitabine Intravesical Therapy Versus Mitomycin C in Patients With Intermediate Risk Superficial Bladder Cancer
- ClinicalTrials.gov ID
- NCT00192049
- Acronym / sponsor ID
- 8048
- Conditions
- Superficial Bladder Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Study completion
- Apr 2007 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gemcitabine | Drug | – |
| mitomycin C | Drug | – |
Primary outcome
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.
3 secondary outcomes
Tumor recurrence rate in 6 months
disease free interval
Toxicity profile (local and systemic)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2007.
- Derived from this study: PubMed 34125951Han 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.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
Related trials for Superficial Bladder Cancer
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RecruitingPhase 1/2
LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve
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Superficial Bladder Cancer, Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine and mitomycin C in people with Superficial Bladder Cancer, run by Eli Lilly and Company at 5 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00192049, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2007; AzTrials last refreshed its copy on 27 Oct 2026.