An Open Randomised Phase II Study Of Gemcitabine Plus Cisplatin +/- Concomitant or Sequential ZD1839 in Patients With Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Bladder Cancer
Both
Bladder Cancer
Trial Information
An Open Randomised Phase II Study Of Gemcitabine Plus Cisplatin +/- Concomitant or Sequential ZD1839 in Patients With Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time to progression (TTP)
Principal Investigator
AstraZeneca Iressa Medical Science Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
1839IL/0063
NCT ID:
NCT00246974
Start Date:
May 2003
Completion Date:
December 2007
Related Keywords:
- Bladder Cancer
- bladder cancer
- Transitionel cell cancer of the urothelium
- Urinary Bladder Neoplasms
- Carcinoma, Transitional Cell
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