Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium

Phase 2

Completed

• Conditions: Transitional Cell Carcinoma; Bladder Neoplasms; Kidney Neoplasms; Ureter Neoplasms; Bladder Cancer; Neoplasm, Bladder
• Interventions: Drug: vinflunine

• Registration Number: NCT00101608
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-01-12
• Study First Submitted QC: 2005-01-12
• Study First Posted: 2005-01-13
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2008-08
• Disposition First Submitted: 2010-02-27
• Disposition First Submitted QC: 2010-02-27
• Last Update Submitted: 2010-02-27
• Disposition First Posted: 2010-03-02
• Last Update Posted: 2010-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	vinflunine	-

Primary Outcome Measures

Name	Time	Method
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.	10-Apr-2007

Secondary Outcome Measures

Name	Time	Method
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	10-April-2007

Trial Locations

Locations (2)

Local Institution; 🇹🇭 Bangkok, Thailand

Local Insitution; 🇨🇦 Toronto, Ontario, Canada