Phase II Gemcitabine + Cisplatin +/- Iressa Bladder CCT
Study identifier:1839IL/0063
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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
Medical condition
Bladder Cancer
Phase
Phase 2
Healthy volunteers
No
Study drug
Gemcitabine, Cisplatin, Gefitinib
Sex
All
Actual Enrollment
108
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Dec 2003
Primary Completion Date: 01 Sept 2008
Study Completion Date: 01 Sept 2008
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 Cisplatin + Gemcitabin | Drug: Gemcitabine intravenous Drug: Cisplatin intravenous |
| Experimental: 2 Cisplatin + Gemcitabin + Gefitinib | Drug: Gemcitabine intravenous Drug: Cisplatin intravenous Drug: Gefitinib oral Other Name: Iressa Other Name: ZD1839 |
Contacts
Investigators
Principal Investigator
AstraZeneca Iressa Medical Science Director
AstraZeneca
