Clinical trial · Interventional
Salvage Docetaxel for Pretreated Urothelial Cancer
A Phase II Study of Salvage Docetaxel in Patients With Advanced Urothelial Cancer Failed to Prior Chemotherapy
- 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)
Based on the previous clinical experience in other cancers, and considering the absence of current standard salvage regimens, the single agent docetaxel is selected as the regimen for this phase II study. Main toxicity of docetaxel is myelosuppression. The low rate of severe myelosuppression observed in other cancer trials warrants further study in urothelial cancer. The objective of the study is to evaluate the safety and activity of weekly docetaxel given as salvage therapy for advanced urothelial cancer.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- docetaxel
- description
- Days 1 \& 8 Docetaxel 35 mg/m2 IV
- interventionNames
- Drug: Docetaxel
Primary outcomes (1)
- measure
- response rate
- timeFrame
- 6 weeks
Secondary outcomes (1)
- measure
- progression-free survival
- timeFrame
- 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * aged over 20 years or older * histologically confirmed metastatic and/or unresectable urothelial carcinoma arising from bladder, ureter, or renal pelvis * ECOG performance status of 0 or 1 * measurable disease, or evaluable lesion(s), as defined by RECIST * clinical failure of the prior chemotherapy for advanced disease, including gemcitabine and platinum * adequate major organ functions * written informed consent Exclusion Criteria: * severe co-morbid illness and/or active infections * prior treatment with taxanes (paclitaxel and docetaxel) * any patients judged by the investigator to be unfit to participate in the study
References
Publications (0)
Data not yet available