Status:
COMPLETED
Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Pierre Fabre Medicament
Conditions:
Transitional Cell Carcinoma
Bladder Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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. T...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2007
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00101608
Start Date
January 1 2005
End Date
April 1 2007
Last Update
March 2 2010
Active Locations (75)
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1
Local Institution
Beverly Hills, California, United States
2
Local Institution
La Jolla, California, United States
3
Local Institution
Los Angeles, California, United States
4
Local Institution
Santa Monica, California, United States