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A Phase II Study of Intravenous (IV) Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma (TCC) of the Urothelium


Phase 2
18 Years
N/A
Not Enrolling
Both
Transitional Cell Carcinoma, Bladder Neoplasms, Kidney Neoplasms, Ureter Neoplasms, Bladder Cancer, Neoplasm, Bladder

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Trial Information

A Phase II Study of Intravenous (IV) Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma (TCC) of the Urothelium


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.

Type of Study:

Interventional

Study Design:

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

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.

Outcome Time Frame:

10-Apr-2007

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA183-001

NCT ID:

NCT00101608

Start Date:

January 2005

Completion Date:

April 2007

Related Keywords:

  • Transitional Cell Carcinoma
  • Bladder Neoplasms
  • Kidney Neoplasms
  • Ureter Neoplasms
  • Bladder Cancer
  • Neoplasm, Bladder
  • urothelium
  • Urinary Bladder Neoplasms
  • Neoplasms
  • Carcinoma
  • Carcinoma, Transitional Cell
  • Kidney Neoplasms
  • Ureteral Neoplasms

Name

Location

Local InstitutionChicago, Illinois  
Local InstitutionBaltimore, Maryland  
Local InstitutionBronx, New York  
Local InstitutionCincinnati, Ohio  
Local InstitutionVancouver, Washington  
Local InstitutionGreen Bay, Wisconsin  
Local InstitutionCorona, California  
Local InstitutionAurora, Colorado  
Local InstitutionHamden, Connecticut  
Local InstitutionWashington, District of Columbia  
Local InstitutionFort Lauderdale, Florida  
Local InstitutionSpringfield, Massachusetts  
Local InstitutionWilmington, North Carolina  
Local InstitutionDuncansville, Pennsylvania  
Local InstitutionAustin, Texas  
Local InstitutionRome, Georgia  
Local InstitutionProvidence, Rhode Island  
Local InstitutionChattanooga, Tennessee  
Local InstitutionColumbia, Missouri  
Local InstitutionLouisville, Kentucky  
Local InstitutionDetroit, Michigan  
Local InstitutionHonolulu, Hawaii  
Local InstitutionLas Vegas, Nevada  
Local InstitutionLebanon, New Hampshire