Transitional Cell CarcinomaPhase 2NCT00101608
Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium
A Phase 2 study testing vinflunine in people with Transitional Cell Carcinoma and Bladder Neoplasms, run by Bristol-Myers Squibb at 75 sites in 15 countries.
Trial summary
The purpose of this clinical research study is to learn if vinflunine can shrink or slow the growth of the cancer or increase survival in patients with transitional cell carcinoma of the urothelium. The safety of this treatment will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transitional Cell Carcinoma, Bladder Neoplasms, Kidney Neoplasms
- What is being tested?
- vinflunine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 75 sitesin 15 countries
- Study dates
- Jan 2005to 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
- Clinical diagnosis of transitional cell carcinoma of the urothelium that is locally advanced or metastatic (i.e. patients cannot be candidates for local/regional control of disease).
- Relapse or progression within 12.5 months of prior cisplatin or carboplatin containing chemotherapy regimen.
- Adequate performance status (Karnofsky greater or equal to 80).
Who cannot join
- Receipt of more than 1 prior chemotherapy regimen in any setting.
- Prior discontinuation of platinum due solely to toxicity.
- Current neuropathy greater or equal to CTC grade 2.
- Prior radiation to greater or equal to 30% of bone marrow.
- Inadequate hematologic function: ANC <1,500 cells/mm3, Platelet<100,000 cells/mm3.
- Inadequate hepatic function: total bilirubin > 1.5 times ULN, ALT/AST > 2.5 times ULN or > 5 times ULN in case of liver metastasis.
- Inadequate renal function: creatinine clearance <20 ml/min.
- Prior allergy to any vinca-alkaloid.
Trial locations and contacts
75 sites in 15 countries.
75 sites in 15 countries
United States38 sites
Local Institution
Ann Arbor, Michigan
Local Institution
Atlanta, Georgia
Local Institution
Aurora, Colorado
Local Institution
Baltimore, Maryland
Local Institution
Beverly Hills, California
Local Institution
Buffalo, New York
Local Institution
Burlington, Massachusetts
Local Institution
Charlotte, North Carolina
Local Institution
Chicago, Illinois
Local Institution
Cincinnati, Ohio
Local Institution
Dallas, Texas
Local Institution
Detroit, Michigan
Local Institution
Durham, North Carolina
Local Institution
Honolulu, Hawaii
Local Institution
Jacksonville, Florida
Local Institution
Joliet, Illinois
Local Institution
Kansas City, Missouri
Local Institution
La Jolla, California
Local Institution
Las Vegas, Nevada
Local Institution
Lebanon, New Hampshire
Local Institution
Los Angeles, California
Local Institution
Louisville, Kentucky
Local Institution
Miami, Florida
Local Institution
Milwaukee, Wisconsin
Local Institution
Nashville, Tennessee
Local Institution
New Haven, Connecticut
Local Institution
New York, New York
Local Institution
Philadelphia, Pennsylvania
Local Institution
Pittsburgh, Pennsylvania
Local Institution
Providence, Rhode Island
Local Institution
Santa Monica, California
Local Institution
Seattle, Washington
Local Institution
St Louis, Missouri
Local Institution
Stanford, California
Local Institution
The Bronx, New York
Local Institution
Urbana, Illinois
Local Institution
Vallejo, California
Local Institution
Washington D.C., District of Columbia
Australia6 sites
Local Institution
Adelaide, South Australia
Local Institution
Liverpool, New South Wales
Local Institution
Sydney, New South Wales
Local Institution
Taree, New South Wales
Local Institution
Waratah, New South Wales
Local Institution
Westmead, New South Wales
France5 sites
Local Institution
Caen
Local Institution
Le Mans
Local Institution
Nice
Local Institution
Paris
Local Institution
Toulouse
Italy5 sites
Local Institution
Genova
Local Institution
Milan
Local Institution
Roma
Local Institution
Rome
Local Institution
Viterbo
Canada4 sites
Local Institution
Edmonton, Alberta
Local Institution
London, Ontario
Local Institution
Montreal, Quebec
Local Insitution
Toronto, Ontario
Spain4 sites
Local Institution
Murcia
Local Institution
Palma de Mallorca
Local Institution
Santander
Local Institution
Seville
Philippines3 sites
Local Institution
Cebu City
Local Institution
Quezon
Local Institution
Quezon City
About this study
Official title: A Phase II Study of Intravenous (IV) Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma (TCC) of the Urothelium
The purpose of this clinical research study is to learn if vinflunine can shrink or slow the growth of the cancer or increase survival in patients with transitional cell carcinoma of the urothelium. The safety of this treatment will also be studied.
- Conditions
- Transitional Cell Carcinoma, Bladder Neoplasms, Kidney Neoplasms, Ureter Neoplasms, Bladder Cancer, Neoplasm, Bladder
- Being tested
- vinflunine
- Keywords
- urothelium
- Medical subject headings
- Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Kidney Neoplasms, Ureteral Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vinflunineDrug
solution for injection, IV, 280/320 mg/m2, every 3 wks, variable duration
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: vinflunine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the objective response rate in patients with TCC of the urothelium receiving vinflunine, who had evidence of documented progression at any time within 12 months after the last dose of platinum therapy and are not candidates of cystectomy.
Measured: 10-Apr-2007
Secondary outcomes (1)
To estimate duration of response, time to response disease control rate, progression free survival, and overall survival in this patient population, and evaluate the safety profile of vinflunine
Measured: 10-April-2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2005 (estimated)
- Study startJan 2005
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transitional Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pierre Fabre Medicament
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00101608
- Sponsor's protocol ID
- CA183-001
- Status last verified
- Aug 2008
- First submitted
- 12 Jan 2005
- Last updated
- 2 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Intravenous (IV) Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma (TCC) of the Urothelium
- ClinicalTrials.gov ID
- NCT00101608
- Acronym / sponsor ID
- CA183-001
- Conditions
- Transitional Cell Carcinoma, Bladder Neoplasms, Kidney Neoplasms, Ureter Neoplasms, Bladder Cancer, Neoplasm, Bladder
- Keywords
- urothelium
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Pierre Fabre Medicament
- Study start
- Jan 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 13 Jan 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 clinical research study is to learn if vinflunine can shrink or slow the growth of the cancer or increase survival in patients with transitional cell carcinoma of the urothelium. The safety of this treatment will also be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: vinflunine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of transitional cell carcinoma of the urothelium that is locally advanced or metastatic (i.e. patients cannot be candidates for local/regional control of disease).
- Relapse or progression within 12.5 months of prior cisplatin or carboplatin containing chemotherapy regimen.
- Adequate performance status (Karnofsky greater or equal to 80).
Key exclusion criteria (8 listed)
- Receipt of more than 1 prior chemotherapy regimen in any setting.
- Prior discontinuation of platinum due solely to toxicity.
- Current neuropathy greater or equal to CTC grade 2.
- Prior radiation to greater or equal to 30% of bone marrow.
- Inadequate hematologic function: ANC <1,500 cells/mm3, Platelet<100,000 cells/mm3.
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 |
|---|---|---|
| vinfluninesolution for injection, IV, 280/320 mg/m2, every 3 wks, variable duration | Drug | 1 |
Primary outcome
To estimate the objective response rate in patients with TCC of the urothelium receiving vinflunine, who had evidence of documented progression at any time within 12 months after the last dose of platinum therapy and are not candidates of cystectomy.
Time frame: 10-Apr-2007
1 secondary outcome
To estimate duration of response, time to response disease control rate, progression free survival, and overall survival in this patient population, and evaluate the safety profile of vinflunine
Time frame: 10-April-2007
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 2 Mar 2010.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
75 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing vinflunine in people with Transitional Cell Carcinoma and Bladder Neoplasms, run by Bristol-Myers Squibb at 75 sites in 15 countries.
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 3 inclusion and 8 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 2 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in United States, Australia, France, Italy, Canada and 10 more countries. 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 estimate the objective response rate in patients with TCC of the urothelium receiving vinflunine, who had evidence of documented progression at any time within 12 months after the last dose of platinum therapy and are not candidates of cystectomy. (time frame: 10-Apr-2007). 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 2 Mar 2010.