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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
October 31, 2005
November 1, 2005
October 15, 2008
May 2003
October 2007   (Final data collection date for primary outcome measure)
Time to progression (TTP)
Same as current
Complete list of historical versions of study NCT00246974 on ClinicalTrials.gov Archive Site
  • 1. Response rate
  • 2. Overall survival time
  • 3. Time to treatment failure
  • 4. Disease control rate
  • 5. Duration of response
  • 6. Safety and tolerability
Same as current
Not Provided
Not Provided
 
Phase II Gemcitabine + Cisplatin +/- Iressa Bladder CCT
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Bladder Cancer
  • Drug: Gemcitabine
    intravenous
  • Drug: Cisplatin
    intravenous
  • Drug: Gefitinib
    oral
    Other Names:
    • Iressa
    • ZD1839
  • Active Comparator: 1
    Cisplatin + Gemcitabin
    Interventions:
    • Drug: Gemcitabine
    • Drug: Cisplatin
  • Experimental: 2
    Cisplatin + Gemcitabin + Gefitinib
    Interventions:
    • Drug: Gemcitabine
    • Drug: Cisplatin
    • Drug: Gefitinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
125
December 2007
October 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
Switzerland
 
NCT00246974
1839IL/0063
D7913L00063
Not Provided
Not Provided
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: AstraZeneca Iressa Medical Science Director, MD AstraZeneca
AstraZeneca
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP