Salvage Docetaxel for Pretreated Urothelial Cancer
A Phase II Study of Salvage Docetaxel in Patients With Advanced Urothelial Cancer Failed to Prior Chemotherapy
1 other identifier
interventional
31
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2010
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 26, 2012
CompletedFirst Posted
Study publicly available on registry
October 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedMay 15, 2014
October 1, 2012
2.7 years
September 26, 2012
May 14, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
response rate
6 weeks
Secondary Outcomes (1)
progression-free survival
6 weeks
Other Outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
every 3 weeks
Study Arms (1)
docetaxel
EXPERIMENTALDays 1 \& 8 Docetaxel 35 mg/m2 IV
Interventions
Treatment will be continued until progression, unacceptable toxicity, or refusal
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, Gangnam-gu, 135710, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Soon Il Lee, MD
Dankook University Hospital, Cheonan, Korea
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2012
First Posted
October 22, 2012
Study Start
August 1, 2010
Primary Completion
April 1, 2013
Study Completion
December 1, 2013
Last Updated
May 15, 2014
Record last verified: 2012-10