MedDataX Logo

Phase II Gemcitabine + Cisplatin +/- Iressa Bladder CCT

NCT ID: NCT00246974

Last Updated: 2008-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2007-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bladder Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

bladder cancer Transitionel cell cancer of the urothelium

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Cisplatin + Gemcitabin

Group Type ACTIVE_COMPARATOR

Gemcitabine

Intervention Type DRUG

intravenous

Cisplatin

Intervention Type DRUG

intravenous

2

Cisplatin + Gemcitabin + Gefitinib

Group Type EXPERIMENTAL

Gemcitabine

Intervention Type DRUG

intravenous

Cisplatin

Intervention Type DRUG

intravenous

Gefitinib

Intervention Type DRUG

oral

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gemcitabine

intravenous

Intervention Type DRUG

Cisplatin

intravenous

Intervention Type DRUG

Gefitinib

oral

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Iressa ZD1839

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

AstraZeneca Iressa Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Aachen, , Germany

Site Status

Research Site

Augsburg, , Germany

Site Status

Research Site

Berlin, , Germany

Site Status

Research Site

Dresden, , Germany

Site Status

Research Site

Freiburg im Breisgau, , Germany

Site Status

Research Site

Halle, , Germany

Site Status

Research Site

Hamburg, , Germany

Site Status

Research Site

Hanover, , Germany

Site Status

Research Site

Kassel, , Germany

Site Status

Research Site

Mainz, , Germany

Site Status

Research Site

Mannheim, , Germany

Site Status

Research Site

Münster, , Germany

Site Status

Research Site

Tübingen, , Germany

Site Status

Research Site

Ulm, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D7913L00063

Identifier Type: -

Identifier Source: secondary_id

1839IL/0063

Identifier Type: -

Identifier Source: org_study_id