Phase II Gemcitabine + Cisplatin +/- Iressa Bladder CCT

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00246974
First received: October 31, 2005
Last updated: October 14, 2008
Last verified: October 2008

October 31, 2005
October 14, 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00246974
1839IL/0063, D7913L00063
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