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Phase II Gemcitabine + Cisplatin +/- Iressa Bladder CCT

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00246974
First Posted: November 1, 2005
Last Update Posted: October 15, 2008
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.
Information provided by:
AstraZeneca
  Purpose
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
intravenous
Drug: Cisplatin
intravenous
Experimental: 2
Cisplatin + Gemcitabin + Gefitinib
Drug: Gemcitabine
intravenous
Drug: Cisplatin
intravenous
Drug: Gefitinib
oral
Other Names:
  • Iressa
  • ZD1839

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
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


Locations
Germany
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
AstraZeneca
Investigators
Study Director: AstraZeneca Iressa Medical Science Director, MD AstraZeneca
  More Information

ClinicalTrials.gov Identifier: NCT00246974     History of Changes
Other Study ID Numbers: 1839IL/0063
D7913L00063
First Submitted: October 31, 2005
First Posted: November 1, 2005
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:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Gemcitabine
Gefitinib
Cisplatin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors