Bladder Cancer Clinical Trial
Official title:
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
| Verified date | October 2008 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Federal Institute for Drugs and Medical Devices |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 125 |
| Est. completion date | December 2007 |
| Est. primary completion date | October 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Research Site | Aachen | |
| Germany | Research Site | Augsburg | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Dresden | |
| Germany | Research Site | Freiburg | |
| Germany | Research Site | Halle/ Saale | |
| Germany | Research Site | Hamburg | |
| Germany | Research Site | Hannover | |
| Germany | Research Site | Kassel | |
| Germany | Research Site | Mainz | |
| Germany | Research Site | Mannheim | |
| Germany | Research Site | Münster | |
| Germany | Research Site | Tübingen | |
| Germany | Research Site | Ulm |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to progression (TTP) | |||
| Secondary | 1. Response rate | |||
| Secondary | 2. Overall survival time | |||
| Secondary | 3. Time to treatment failure | |||
| Secondary | 4. Disease control rate | |||
| Secondary | 5. Duration of response | |||
| Secondary | 6. Safety and tolerability |
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