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Phase II Gemcitabine + Cisplatin +/- Iressa Bladder CCT

Primary Purpose

Bladder Cancer

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Gemcitabine
Cisplatin
Gefitinib
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring bladder cancer, Transitionel cell cancer of the urothelium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Cisplatin + Gemcitabin

Cisplatin + Gemcitabin + Gefitinib

Outcomes

Primary Outcome Measures

Time to progression (TTP)

Secondary Outcome Measures

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

Full Information

First Posted
October 31, 2005
Last Updated
October 14, 2008
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00246974
Brief Title
Phase II Gemcitabine + Cisplatin +/- Iressa Bladder CCT
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
bladder cancer, Transitionel cell cancer of the urothelium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Cisplatin + Gemcitabin
Arm Title
2
Arm Type
Experimental
Arm Description
Cisplatin + Gemcitabin + Gefitinib
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
intravenous
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
intravenous
Intervention Type
Drug
Intervention Name(s)
Gefitinib
Other Intervention Name(s)
Iressa, ZD1839
Intervention Description
oral
Primary Outcome Measure Information:
Title
Time to progression (TTP)
Secondary Outcome Measure Information:
Title
1. Response rate
Title
2. Overall survival time
Title
3. Time to treatment failure
Title
4. Disease control rate
Title
5. Duration of response
Title
6. Safety and tolerability

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Iressa Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Aachen
Country
Germany
Facility Name
Research Site
City
Augsburg
Country
Germany
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Dresden
Country
Germany
Facility Name
Research Site
City
Freiburg
Country
Germany
Facility Name
Research Site
City
Halle/ Saale
Country
Germany
Facility Name
Research Site
City
Hamburg
Country
Germany
Facility Name
Research Site
City
Hannover
Country
Germany
Facility Name
Research Site
City
Kassel
Country
Germany
Facility Name
Research Site
City
Mainz
Country
Germany
Facility Name
Research Site
City
Mannheim
Country
Germany
Facility Name
Research Site
City
Münster
Country
Germany
Facility Name
Research Site
City
Tübingen
Country
Germany
Facility Name
Research Site
City
Ulm
Country
Germany

12. IPD Sharing Statement

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Phase II Gemcitabine + Cisplatin +/- Iressa Bladder CCT

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