NCT00246974

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2003

Typical duration for phase_2

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 1, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

October 15, 2008

Status Verified

October 1, 2008

Enrollment Period

4.4 years

First QC Date

October 31, 2005

Last Update Submit

October 14, 2008

Conditions

Bladder Cancer

Keywords

bladder cancerTransitionel cell cancer of the urothelium

Outcome Measures

Primary Outcomes (1)

  • Time to progression (TTP)

Secondary Outcomes (6)

  • 1. Response rate

  • 2. Overall survival time

  • 3. Time to treatment failure

  • 4. Disease control rate

  • 5. Duration of response

  • +1 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

Cisplatin + Gemcitabin

Drug: GemcitabineDrug: Cisplatin

2

EXPERIMENTAL

Cisplatin + Gemcitabin + Gefitinib

Drug: GemcitabineDrug: CisplatinDrug: Gefitinib

Interventions

GemcitabineDRUG

intravenous

12
CisplatinDRUG

intravenous

12
GefitinibDRUG

oral

Also known as: Iressa, ZD1839
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Research Site

Aachen, Germany

Location

Research Site

Augsburg, Germany

Location

Research Site

Berlin, Germany

Location

Research Site

Dresden, Germany

Location

Research Site

Freiburg im Breisgau, Germany

Location

Research Site

Halle, Germany

Location

Research Site

Hamburg, Germany

Location

Research Site

Hanover, Germany

Location

Research Site

Kassel, Germany

Location

Research Site

Mainz, Germany

Location

Research Site

Mannheim, Germany

Location

Research Site

Münster, Germany

Location

Research Site

Tübingen, Germany

Location

Research Site

Ulm, Germany

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

GemcitabineCisplatinGefitinib

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • AstraZeneca Iressa Medical Science Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 31, 2005

First Posted

November 1, 2005

Study Start

May 1, 2003

Primary Completion

October 1, 2007

Study Completion

December 1, 2007

Last Updated

October 15, 2008

Record last verified: 2008-10

Locations

DE(14)