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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00246974 |
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.
Condition | Intervention | Phase |
---|---|---|
Bladder Cancer |
Drug: Gemcitabine Drug: Cisplatin Drug: Gefitinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 125 |
Study Start Date: | May 2003 |
Study Completion Date: | December 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Cisplatin + Gemcitabin
|
Drug: Gemcitabine
intravenous
Drug: Cisplatin
intravenous
|
2: Experimental
Cisplatin + Gemcitabin + Gefitinib
|
Drug: Gemcitabine
intravenous
Drug: Cisplatin
intravenous
Drug: Gefitinib
oral
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Research Site | |
Augsburg, Germany | |
Research Site | |
Hamburg, Germany | |
Research Site | |
Kassel, Germany | |
Research Site | |
Münster, Germany | |
Research Site | |
Ulm, Germany | |
Research Site | |
Tübingen, Germany | |
Research Site | |
Dresden, Germany | |
Research Site | |
Mainz, Germany | |
Research Site | |
Aachen, Germany | |
Research Site | |
Halle/ Saale, Germany | |
Research Site | |
Berlin, Germany | |
Research Site | |
Mannheim, Germany | |
Research Site | |
Freiburg, Germany | |
Research Site | |
Hannover, Germany |
Study Director: | AstraZeneca Iressa Medical Science Director, MD | AstraZeneca |
Study ID Numbers: | 1839IL/0063, D7913L00063 |
Study First Received: | October 31, 2005 |
Last Updated: | October 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00246974 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
bladder cancer Transitionel cell cancer of the urothelium |
Cystocele Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Neoplasms Carcinoma, Transitional Cell Urologic Neoplasms Transitional cell carcinoma Carcinoma |
Cisplatin Urologic Diseases Gemcitabine Gefitinib Urinary tract neoplasm Neoplasms, Glandular and Epithelial Bladder neoplasm |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |