Status:
COMPLETED
Phase II Gemcitabine + Cisplatin +/- Iressa Bladder CCT
Lead Sponsor:
AstraZeneca
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of the study is to assess the activity of ZD1839 250 mg once daily in addition to the standard chemotherapy in patients with advanced or metastatic transitional cell carcinoma of...
Eligibility Criteria
Inclusion
- Histologically or cytologically-confirmed transitional cell carcinoma of the urothelium
- Locally advanced or metastatic disease
- At least one measurable lesion as defined by RECIST
- Chemotherapy-naiv
Exclusion
- Previous chemotherapy or other systemic antitumour therapy
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma, cervical cancer in situ or locally limited prostate cancer
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00246974
Start Date
May 1 2003
End Date
December 1 2007
Last Update
October 15 2008
Active Locations (14)
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1
Research Site
Aachen, Germany
2
Research Site
Augsburg, Germany
3
Research Site
Berlin, Germany
4
Research Site
Dresden, Germany