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A Phase II Study of Salvage Docetaxel in Patients With Advanced Urothelial Cancer Failed to Prior Chemotherapy


Phase 2
20 Years
75 Years
Open (Enrolling)
Both
Urothelial Cancer

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Trial Information

A Phase II Study of Salvage Docetaxel in Patients With Advanced Urothelial Cancer Failed to Prior Chemotherapy


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response rate

Outcome Time Frame:

6 weeks

Safety Issue:

No

Principal Investigator

Soon Il Lee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dankook University Hospital, Cheonan, Korea

Authority:

Korea: Food and Drug Administration

Study ID:

2010-03-072

NCT ID:

NCT01711112

Start Date:

August 2010

Completion Date:

April 2013

Related Keywords:

  • Urothelial Cancer

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