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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00101608
Other study ID # CA183-001
Secondary ID
Status Completed
Phase Phase 2
First received January 12, 2005
Last updated February 27, 2010
Start date January 2005
Est. completion date April 2007

Study information

Verified date August 2008
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical 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.


Other known NCT identifiers
  • NCT00268424

Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date April 2007
Est. primary completion date April 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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:

- 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Bristol-Myers Squibb Pierre Fabre Medicament

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  France,  Greece,  Indonesia,  Italy,  Korea, Republic of,  Philippines,  Singapore,  Spain,  Sweden,  Switzerland,  Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 10-Apr-2007 No
Secondary 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 10-April-2007 Yes
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