Brief Title
Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium
Official Title
A Phase II Study of Intravenous (IV) Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma (TCC) of the Urothelium
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. The safety of this treatment will also be studied.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
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.
Secondary Outcome
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
Condition
Transitional Cell Carcinoma
Intervention
vinflunine
Study Arms / Comparison Groups
1
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
150
Start Date
January 2005
Completion Date
April 2007
Primary Completion Date
April 2007
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Bristol-Myers Squibb, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT00101608
Organization ID
CA183-001
Study Sponsor
Bristol-Myers Squibb
Collaborators
Pierre Fabre Medicament
Study Sponsor
Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb
Verification Date
August 2008