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CompletedNCT00246974Updated Oct 15, 2008

Phase II Gemcitabine + Cisplatin +/- Iressa Bladder CCT

A Phase 2 interventional study of Gemcitabine and Cisplatin in Bladder Cancer, sponsored by AstraZeneca. Completed at 14 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-10-15.

Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
125
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Bladder Cancer

Keywords

  • bladder cancer
  • Transitionel cell cancer of the urothelium
03

In context

Urinary Bladder Neoplasms

1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.

This study's planned enrollment of 125 is above the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
125 participants (estimated)

Study arms

  • Active comparator
    1

    Cisplatin + Gemcitabin

    Drug: Gemcitabine · Drug: Cisplatin

  • Experimental
    2

    Cisplatin + Gemcitabin + Gefitinib

    Drug: Gemcitabine · Drug: Cisplatin · Drug: Gefitinib

Interventions

  • DrugGemcitabine

    intravenous

  • DrugCisplatin

    intravenous

  • DrugGefitinib

    oral

    Also known as: Iressa, ZD1839

06

What researchers measure

Primary outcomes

  1. Time to progression (TTP)

Secondary outcomes

  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

07

Study locations

14 sites
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00246974
Lead sponsor
AstraZeneca
First posted
Nov 1, 2005
Start date
May 2003
Primary completion
Oct 2007
Completion
Dec 2007
Last update
Oct 15, 2008

Study contacts

AstraZeneca Iressa Medical Science Director, MD
study director · AstraZeneca
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.

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