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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00246974

Enrollment

125

Registered

2005-11-01

Start date

2003-05-31

Completion date

2007-12-31

Last updated

2008-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Keywords

bladder cancer, Transitionel cell cancer of the urothelium

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.

Interventions

DRUGGemcitabine

intravenous

DRUGCisplatin

intravenous

DRUGGefitinib

oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Time to progression (TTP)	—

Secondary

Measure	Time frame
2. Overall survival time	—
3. Time to treatment failure	—
1. Response rate	—
5. Duration of response	—
6. Safety and tolerability	—
4. Disease control rate	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026