Status:
UNKNOWN
Activity Study of Sunitinib In Metastatic Pretreated Urothelial Cancer
Lead Sponsor:
Campania Younger Oncologists Association
Conditions:
Urinary Bladder Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
Gemcitabine and cisplatin represent the standard first-line chemotherapy in metastatic bladder carcinoma. This regimen has replaced in most centers the MVAC combination showing a similar efficacy but ...
Detailed Description
OBJECTIVES * PRIMARY To determine the antitumor efficacy ( response rate) of sunitinib * SECONDARY To determine: safety, duration of response, Quality of life (QoL), progression free survival (PFS) a...
Eligibility Criteria
Inclusion
- cytological confirmation of UROTHELIAL carcinoma
- Failure of Cisplatin-gemcitabine regimen as first-line
- Presence of measurable metastases
- Performance status 0-1 ECOG
- Age of 18 years or older
- Written informed consent
- Adequate organ function ( based on tests of hematologic, hepatic, renal and cardiac function).
Exclusion
- administration of a previous biological therapy ( sorafenib , bevacizumab or mTor Inhibitor)
- brain metastases
- significant cardiac events within the 6 months prior to study drug administration.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00818350
Start Date
January 1 2009
End Date
January 1 2011
Last Update
January 7 2009
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