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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 Institution Chicago, Illinois  
Local Institution Baltimore, Maryland  
Local Institution Bronx, New York  
Local Institution Cincinnati, Ohio  
Local Institution Vancouver, Washington  
Local Institution Green Bay, Wisconsin  
Local Institution Corona, California  
Local Institution Aurora, Colorado  
Local Institution Hamden, Connecticut  
Local Institution Washington, District of Columbia  
Local Institution Fort Lauderdale, Florida  
Local Institution Springfield, Massachusetts  
Local Institution Wilmington, North Carolina  
Local Institution Duncansville, Pennsylvania  
Local Institution Austin, Texas  
Local Institution Rome, Georgia  
Local Institution Providence, Rhode Island  
Local Institution Chattanooga, Tennessee  
Local Institution Columbia, Missouri  
Local Institution Louisville, Kentucky  
Local Institution Detroit, Michigan  
Local Institution Honolulu, Hawaii  
Local Institution Las Vegas, Nevada  
Local Institution Lebanon, New Hampshire