Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium
Completed · Phase 2
Conditions studied: Transitional Cell Carcinoma, Bladder Neoplasms, Kidney Neoplasms, Ureter Neoplasms, Bladder Cancer, Neoplasm, Bladder
In brief
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.
Key facts
- Study ID
- NCT00101608
- Run by
- Bristol-Myers Squibb
- People needed
- 150
- Starts
- 2005-01-01
- Expected to finish
- 2007-04-01
- Last updated by the study team
- 2010-03-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- Local Institution — La Jolla, California, United States
- Local Institution — Los Angeles, California, United States
- Local Institution — Santa Monica, California, United States
- Local Institution — Stanford, California, United States
- Local Institution — Vallejo, California, United States
- Local Institution — Aurora, Colorado, United States
- Local Institution — New Haven, Connecticut, United States
- Local Institution — Washington D.C., District of Columbia, United States
- Local Institution — Jacksonville, Florida, United States
- Local Institution — Miami, Florida, United States
- Local Institution — Atlanta, Georgia, United States
- Local Institution — Honolulu, Hawaii, United States
- Local Institution — Chicago, Illinois, United States
- Local Institution — Joliet, Illinois, United States
- Local Institution — Urbana, Illinois, United States
- Local Institution — Louisville, Kentucky, United States
- Local Institution — Baltimore, Maryland, United States
- Local Institution — Burlington, Massachusetts, United States
- Local Institution — Ann Arbor, Michigan, United States
- Local Institution — Detroit, Michigan, United States
- Local Institution — Kansas City, Missouri, United States
- Local Institution — St Louis, Missouri, United States
- Local Institution — Las Vegas, Nevada, United States
- Local Institution — Lebanon, New Hampshire, United States
- Local Institution — Beverly Hills, California, United States
Full record on ClinicalTrials.gov
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