Clinical trial · Interventional
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
NCT00101608CI-TRIAL-00003218completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Bladder Neoplasms | Bladder Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Kidney Neoplasms | Kidney Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Neoplasm, Bladder | Bladder Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Transitional Cell Carcinoma | Transitional Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Ureter Neoplasms | Ureter Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| vinflunine | Drug | Vinflunine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: vinflunine
Primary outcomes (1)
- measure
- 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.
- timeFrame
- 10-Apr-2007
Secondary outcomes (1)
- measure
- 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
- timeFrame
- 10-April-2007
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.