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CompletedNCT00101608Updated Mar 2, 2010

Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium

A Phase 2 interventional study of vinflunine in Transitional Cell Carcinoma, Bladder Neoplasms and Kidney Neoplasms, sponsored by Bristol-Myers Squibb. Completed at 75 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-03-02.

Sponsored by Bristol-Myers Squibb · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
150
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Transitional Cell Carcinoma
  • Bladder Neoplasms
  • Kidney Neoplasms
  • Ureter Neoplasms
  • Bladder Cancer
  • Neoplasm, Bladder

Keywords

  • urothelium
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 150 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    1

    Drug: vinflunine

Interventions

  • Drugvinflunine

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

06

What researchers measure

Primary outcomes

  1. 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

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

    Time frame: 10-April-2007

07

Study locations

75 sites
  • Local Institution
    Beverly Hills, California, United States
  • Local Institution
    La Jolla, California, United States
  • Local Institution
    Los Angeles, California, United States
  • Local Institution
    Santa Monica, California, United States
  • Local Institution
    Stanford, California, United States
  • Local Institution
    Vallejo, California, United States
  • Local Institution
    Aurora, Colorado, United States
  • Local Institution
    New Haven, Connecticut, United States
  • Local Institution
    Washington, District of Columbia, United States
  • Local Institution
    Jacksonville, Florida, United States
  • Local Institution
    Miami, Florida, United States
  • Local Institution
    Atlanta, Georgia, United States
  • Local Institution
    Honolulu, Hawaii, United States
  • Local Institution
    Chicago, Illinois, United States
  • Local Institution
    Joliet, Illinois, United States
  • Local Institution
    Urbana, Illinois, United States
  • Local Institution
    Louisville, Kentucky, United States
  • Local Institution
    Baltimore, Maryland, United States
  • Local Institution
    Burlington, Massachusetts, United States
  • Local Institution
    Ann Arbor, Michigan, United States
  • Local Institution
    Detroit, Michigan, United States
  • Local Institution
    Kansas City, Missouri, United States
  • Local Institution
    St. Louis, Missouri, United States
  • Local Institution
    Las Vegas, Nevada, United States
  • Local Institution
    Lebanon, New Hampshire, United States
  • Local Institution
    Bronx, New York, United States
  • Local Institution
    Buffalo, New York, United States
  • Local Institution
    New York, New York, United States
  • Local Institution
    Charlotte, North Carolina, United States
  • Local Institution
    Durham, North Carolina, United States
  • Local Institution
    Cincinnati, Ohio, United States
  • Local Institution
    Philadelphia, Pennsylvania, United States
  • Local Institution
    Pittsburgh, Pennsylvania, United States
  • Local Institution
    Providence, Rhode Island, United States
  • Local Institution
    Nashville, Tennessee, United States
  • Local Institution
    Dallas, Texas, United States
  • Local Institution
    Seattle, Washington, United States
  • Local Institution
    Milwaukee, Wisconsin, United States
  • Local Institution
    Liverpool, New South Wales, Australia
  • Local Institution
    Sydney, New South Wales, Australia
  • Local Institution
    Taree, New South Wales, Australia
  • Local Institution
    Waratah, New South Wales, Australia
  • Local Institution
    Westmead, New South Wales, Australia
  • Local Institution
    Adelaide, South Australia, Australia
  • Local Institution
    Linz, Austria
  • Local Institution
    Salzburg, Austria
  • Local Institution
    Edmonton, Alberta, Canada
  • Local Institution
    London, Ontario, Canada
  • Local Insitution
    Toronto, Ontario, Canada
  • Local Institution
    Montreal, Quebec, Canada
  • Local Institution
    Caen, France
  • Local Institution
    Le Mans Cedex 2, France
  • Local Institution
    Nice, France
  • Local Institution
    Paris, France
  • Local Institution
    Toulouse, France
  • Local Institution
    Ilion, Greece
  • Local Institution
    Jakarta, Indonesia
  • Local Institution
    Genova, Italy
  • Local Institution
    Milan, Italy
  • Local Institution
    Roma, Italy
  • Local Institution
    Rome, Italy
  • Local Institution
    Viterbo, Italy
  • Local Institution
    Seoul, Korea, Republic of
  • Local Institution
    Cebu City, Philippines
  • Local Institution
    Quezon City, Philippines
  • Local Institution
    Quezon, Philippines
  • Local Institution
    Singapore, Singapore
  • Local Institution
    Murcia, Spain
  • Local Institution
    Palma De Mallorca, Spain
  • Local Institution
    Santander, Spain
  • Local Institution
    Sevilla, Spain
  • Local Institution
    Linkoping, Sweden
  • Local Institution
    Uppsala, Sweden
  • Local Institution
    Aarau, Switzerland
  • Local Institution
    Bangkok, Thailand
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00101608
Lead sponsor
Bristol-Myers Squibb
Collaborators
Pierre Fabre Medicament
First posted
Jan 13, 2005
Start date
Jan 2005
Primary completion
Apr 2007
Completion
Apr 2007
Last update
Mar 2, 2010

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.

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