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Phase II Gemcitabine + Cisplatin +/- Iressa Bladder CCT

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: October 31, 2005
Last updated: October 14, 2008
Last verified: October 2008
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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Time to progression (TTP)

Secondary Outcome Measures:
  • 1. Response rate
  • 2. Overall survival time
  • 3. Time to treatment failure
  • 4. Disease control rate
  • 5. Duration of response
  • 6. Safety and tolerability

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
Active Comparator: 1
Cisplatin + Gemcitabin
Drug: Gemcitabine
Drug: Cisplatin
Experimental: 2
Cisplatin + Gemcitabin + Gefitinib
Drug: Gemcitabine
Drug: Cisplatin
Drug: Gefitinib
Other Names:
  • Iressa
  • ZD1839


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00246974

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, Germany
Sponsors and Collaborators
Study Director: AstraZeneca Iressa Medical Science Director, MD AstraZeneca
  More Information Identifier: NCT00246974     History of Changes
Other Study ID Numbers: 1839IL/0063
Study First Received: October 31, 2005
Last Updated: October 14, 2008

Keywords provided by AstraZeneca:
bladder cancer
Transitionel cell cancer of the urothelium

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors processed this record on August 23, 2017