Phase II Gemcitabine + Cisplatin +/- Iressa Bladder CCT
Phase 2
Completed
- Conditions
- Bladder Cancer
- Interventions
- Registration Number
- NCT00246974
- Lead Sponsor
- AstraZeneca
- 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 the urothelium by estimating the time to progression.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 125
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Cisplatin Cisplatin + Gemcitabin + Gefitinib 2 Gefitinib Cisplatin + Gemcitabin + Gefitinib 2 Gemcitabine Cisplatin + Gemcitabin + Gefitinib 1 Gemcitabine Cisplatin + Gemcitabin 1 Cisplatin Cisplatin + Gemcitabin
- Primary Outcome Measures
Name Time Method Time to progression (TTP)
- Secondary Outcome Measures
Name Time Method 1. Response rate 2. Overall survival time 3. Time to treatment failure 4. Disease control rate 5. Duration of response 6. Safety and tolerability
Trial Locations
- Locations (1)
Research Site
🇩🇪Ulm, Germany