Superficial Bladder CancerPhase 2NCT00191711
Intravesical Gemcitabine Instillation Followed by Transurethral Resection for the Treatment of Patients With Superficial Bladder Cancer at Low Risk.
A Phase 2 study testing Gemcitabine in people with Superficial Bladder Cancer, run by Eli Lilly and Company at 1 site in Italy.
Trial summary
The purpose of this study is to determine whether neoadjuvant intravesical Gemcitabine is enough active in patients with a solitary, low risk superficial bladder cancer.After diagnostic urethrocystoscopy or bladder sonography, all patients will receive intravesical gemcitabine once a week during 6 weeks. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Superficial Bladder Cancer
- What is being tested?
- Gemcitabine
- How many people
- 43 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2004to Oct 2005
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary solitary bladder tumour not exceeding 2 cm of diameter at sonography and/or at cystoscopy, judged by the investigator not muscle infiltrating and at low risk
- Urinary cytology negative for severe dysplasia (G3).
- ECOG performance status 0-1
- Absence of anti-coagulant therapy or acetyl-salicylic acid chronic therapy
- Absence of other present or past neoplasias except for healed skin basalioma
Who cannot join
- Tumours with infiltrative patterns at cystoscopy
- Transitional carcinoma of the upper urinary tract and prostatic urethra.
- Any previous or concomitant malignancy other than superficial bladder cancer with the exception of cutaneous basalioma and/or cancer of the cervix, adequately treated.
Trial locations and contacts
1 site in 1 country.
Italy1 site
For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Mon - Fri 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your physician
Sesto Fiorentino, Florence, 50019
About this study
Official title: Phase II Study of 6 Weeks Intravesical Gemcitabine Instillation Followed By Transurethral Resection in Patients Affected By Superficial Bladder Cancer at Low Risk
The purpose of this study is to determine whether neoadjuvant intravesical Gemcitabine is enough active in patients with a solitary, low risk superficial bladder cancer.After diagnostic urethrocystoscopy or bladder sonography, all patients will receive intravesical gemcitabine once a week during 6 weeks. Two weeks after finishing antiblastic therapy, all patients will be submitted to a new cystoscopy, with TUR or cold biopsies of the site of the initial lesion.
- Conditions
- Superficial Bladder Cancer
- Being tested
- Gemcitabine
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate pathological complete response rate achieved by 6 week neoadjuvant intravesical administration of Gemcitabine followed by transurethral resection (TUR) or cold biopsies, in patients affected by low risk superficial bladder cancer .
Secondary outcomes (1)
To assess toxicity profile in the same group of patients.
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 startFeb 2004
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 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 Monday-Friday 9 am-5 pm Eastern time (UTC/GMT - 5 hours, EST), Study chair, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00191711
- Sponsor's protocol ID
- 8332
- Other IDs
- B9E-MC-S346
- Status last verified
- Jan 2007
- First submitted
- 12 Sep 2005
- Last updated
- 26 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of 6 Weeks Intravesical Gemcitabine Instillation Followed By Transurethral Resection in Patients Affected By Superficial Bladder Cancer at Low Risk
- ClinicalTrials.gov ID
- NCT00191711
- Acronym / sponsor ID
- 8332
- Conditions
- Superficial Bladder Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Study completion
- Oct 2005
- 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.
The purpose of this study is to determine whether neoadjuvant intravesical Gemcitabine is enough active in patients with a solitary, low risk superficial bladder cancer.After diagnostic urethrocystoscopy or bladder sonography, all patients will receive intravesical gemcitabine once a week during 6 weeks. Two weeks after finishing antiblastic therapy, all patients will be submitted to a new cystoscopy, with TUR or cold biopsies of the site of the initial lesion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary solitary bladder tumour not exceeding 2 cm of diameter at sonography and/or at cystoscopy, judged by the investigator not muscle infiltrating and at low risk
- Urinary cytology negative for severe dysplasia (G3).
- ECOG performance status 0-1
- Absence of anti-coagulant therapy or acetyl-salicylic acid chronic therapy
- Absence of other present or past neoplasias except for healed skin basalioma
Key exclusion criteria (3 listed)
- Tumours with infiltrative patterns at cystoscopy
- Transitional carcinoma of the upper urinary tract and prostatic urethra.
- Any previous or concomitant malignancy other than superficial bladder cancer with the exception of cutaneous basalioma and/or cancer of the cervix, adequately treated.
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 | – |
Primary outcome
To evaluate pathological complete response rate achieved by 6 week neoadjuvant intravesical administration of Gemcitabine followed by transurethral resection (TUR) or cold biopsies, in patients affected by low risk superficial bladder cancer .
1 secondary outcome
To assess toxicity profile in the same group of patients.
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 26 Jan 2007.
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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 Monday-Friday 9 am-5 pm Eastern time (UTC/GMT - 5 hours, EST) study chair
Eli Lilly and Company
1 site 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 in people with Superficial Bladder Cancer, run by Eli Lilly and Company at 1 site in Italy.
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 5 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 26 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
To evaluate pathological complete response rate achieved by 6 week neoadjuvant intravesical administration of Gemcitabine followed by transurethral resection (TUR) or cold biopsies, in patients affected by low risk superficial bladder cancer .. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2007.