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

A Phase II Study of Intravenous (IV) Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma (TCC) of the Urothelium

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00101608

Enrollment

150

Registered

2005-01-13

Start date

2005-01-31

Completion date

2007-04-30

Last updated

2010-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer, Bladder Neoplasms, Kidney Neoplasms, Neoplasm, Bladder, Transitional Cell Carcinoma, Ureter Neoplasms

Keywords

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.

Interventions

DRUGvinflunine

solution for injection, IV, 280/320 mg/m2, every 3 wks, variable duration

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Australia, Austria, Canada, France, Greece, Indonesia, Italy, Philippines, Singapore, South Korea, Spain, Sweden, Switzerland, Thailand, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026