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Transitional Cell Carcinoma of the Urothelial TractPhase 3NCT00315237

Phase III Trial of Vinflunine Plus Best Supportive Care vs. Best Supportive Care in Patients With Transitional Cell Carcinoma (TCC) of the Urothelial Tract

A Phase 3 study of Transitional Cell Carcinoma of the Urothelial Tract and Bladder Cancer, run by Pierre Fabre Medicament at 10 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this clinical research study is to learn if patients who receive vinflunine plus best supportive care live longer than patients who receive best supportive care alone. This study will also investigate patient benefit, safety and whether or not vinflunine shrinks or slows the growth of the cancer. Read more about this study

Who is it for?
Ages 18 years and older
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
364 participants
Where
10 sitesCanada
Study dates
Jul 2005to Jan 2008
Phase
Phase 3
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

  • Bladder cancer
  • Progressed after 1st line platinum-chemotherapy
  • >= 18 years old
  • Adequate hematologic, hepatic \& renal function

Who cannot join

  • CNS disease
  • Moderate neuropathy
  • More than 1 previous chemotherapy

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Canada10 sites

  • Local Institution

    Brampton, Ontario

  • Local Institution

    Calgary, Alberta

  • Local Institution

    Edmonton, Alberta

  • Local Institution

    Hamilton, Ontario

  • Local Institution

    Kingston, Ontario

  • Local Institution

    London, Ontario

  • Local Institution

    Montreal, Quebec

  • Local Institution

    Toronto, Ontario

  • Local Institution

    Vancouver, British Columbia

  • Local Institution

    Victoria, British Columbia

Other trials in Canada

About this study

Official title: Prospective, Randomized Phase III Trial of I.V. Vinflunine Plus Best Supportive Care as Second Line Therapy Versus Best Supportive Care After a Platinum-containing Regimen, in Patients With Advanced Transitional Cell Carcinoma of Urothelial Tract

The purpose of this clinical research study is to learn if patients who receive vinflunine plus best supportive care live longer than patients who receive best supportive care alone. This study will also investigate patient benefit, safety and whether or not vinflunine shrinks or slows the growth of the cancer.

Being tested
vinflunine and best supportive care
Medical subject headings
Carcinoma, Transitional Cell, Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • vinflunine and best supportive careDrug

    solution for injection, IV, 280/320 mg/m2, every 3 wks variable duration

Study groups in NCT00315237
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: vinflunine and best supportive care
2No interventionbest supportive care for 18 week duration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. duration of Overall Survival after Randomization

    Measured: 30-March-07

Secondary outcomes (6)

  1. patient benefit

    Measured: 30-Mar-07

  2. safety

    Measured: 30-Mar-2007

  3. response rate

    Measured: throughout the study

  4. time to response

    Measured: upon occurrence

  5. response duration

    Measured: throughout the study

  6. progression free survival

    Measured: throughout the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2006 (estimated)
  2. Study startJul 2005
  3. Primary completionJan 2008
  4. Study completionJan 2008

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
364 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00315237
Sponsor's protocol ID
L0070 IN 302 P1
Other IDs
CA183004
Status last verified
Jan 2010
First submitted
14 Apr 2006
Last updated
7 Jan 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Rassy EE, Bakouny Z, Aoun F, Haddad FG, Sleilaty G, Assi T, Kattan J. A network meta-analysis of the PD(L)-1 inhibitors in the salvage treatment of urothelial bladder cancer. Immunotherapy. 2018 Jun;10(8):657-663. doi: 10.2217/imt-2017-0190. Epub 2018 Mar 22.

    PubMed 29562804

Questions about this trial

What is this clinical trial studying?

A Phase 3 study of Transitional Cell Carcinoma of the Urothelial Tract and Bladder Cancer, run by Pierre Fabre Medicament at 10 sites in Canada.

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 7 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

duration of Overall Survival after Randomization (time frame: 30-March-07). 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 NCT00315237, 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 7 Jan 2010; AzTrials last refreshed its copy on 26 Oct 2026.

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