Phase II Gemcitabine + Cisplatin +/- Iressa Bladder CCT

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

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 the urothelium by estimating the time to progression.

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