Salvage Docetaxel for Pretreated Urothelial Cancer

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Treatments: Docetaxel

Criteria

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