ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00101608
Recruitment Status : Completed
First Posted : January 13, 2005
Last Update Posted : March 2, 2010
Sponsor:
Collaborator:
Pierre Fabre Medicament
Information provided by:
Bristol-Myers Squibb

January 12, 2005
January 13, 2005
March 2, 2010
January 2005
April 2007   (Final data collection date for 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 ]
Not Provided
Complete list of historical versions of study NCT00101608 on ClinicalTrials.gov Archive Site
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 ]
Not Provided
Not Provided
Not Provided
 
Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Transitional Cell Carcinoma
  • Bladder Neoplasms
  • Kidney Neoplasms
  • Ureter Neoplasms
  • Bladder Cancer
  • Neoplasm, Bladder
Drug: vinflunine
solution for injection, IV, 280/320 mg/m2, every 3 wks, variable duration
Experimental: 1
Intervention: Drug: vinflunine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
Not Provided
April 2007
April 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Canada,   France,   Greece,   Indonesia,   Italy,   Korea, Republic of,   Philippines,   Singapore,   Spain,   Sweden,   Switzerland,   Thailand,   United States
Germany
 
NCT00101608
CA183-001
No
Not Provided
Not Provided
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Pierre Fabre Medicament
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP