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Phase II Gemcitabine + Cisplatin +/- Iressa Bladder CCT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00246974
Recruitment Status : Completed
First Posted : November 1, 2005
Last Update Posted : October 15, 2008
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Drug: Gemcitabine Drug: Cisplatin Drug: Gefitinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
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
Study Start Date : May 2003
Actual Primary Completion Date : October 2007
Actual Study Completion Date : December 2007

Arm Intervention/treatment
Active Comparator: 1
Cisplatin + Gemcitabin
Drug: Gemcitabine

Drug: Cisplatin

Experimental: 2
Cisplatin + Gemcitabin + Gefitinib
Drug: Gemcitabine

Drug: Cisplatin

Drug: Gefitinib
Other Names:
  • Iressa
  • ZD1839

Primary Outcome Measures :
  1. Time to progression (TTP)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00246974

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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
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Study Director: AstraZeneca Iressa Medical Science Director, MD AstraZeneca
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ClinicalTrials.gov Identifier: NCT00246974    
Other Study ID Numbers: 1839IL/0063
First Posted: November 1, 2005    Key Record Dates
Last Update Posted: October 15, 2008
Last Verified: October 2008
Keywords provided by AstraZeneca:
bladder cancer
Transitionel cell cancer of the urothelium
Additional relevant MeSH terms:
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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