Phase II Gemcitabine + Cisplatin +/- Iressa Bladder CCT | NCT00246974

Studies
Phase II Gemcitabine + Cisplatin +/- Iressa Bladder CCT

NCT00246974

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Oct 15, 2008Estimated

Enrollment

125Estimated

Phase

Phase 2

Conditions

Bladder Cancer

Interventions

Gemcitabine
Cisplatin
Gefitinib

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
D7913L00063

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2003

Primary Completion Date

Oct 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Oct 31, 2005

First Submission Date that Met QC Criteria

Oct 31, 2005

First Posted Date

Nov 1, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2008

Last Update Posted Date

Oct 15, 2008Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

125Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Cisplatin + Gemcitabin	Drug: Gemcitabine Drug: Cisplatin
2	Experimental	Cisplatin + Gemcitabin + Gefitinib	Drug: Gemcitabine Drug: Cisplatin Drug: Gefitinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gemcitabine	Drug	intravenous	1 2
Cisplatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to progression (TTP)

Secondary Outcomes

Measure	Description	Time Frame
1. Response rate
2. Overall survival time
3. Time to treatment failure

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
AstraZeneca Iressa Medical Science Director, MD	AstraZeneca	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Aachen			Germany
Research Site

Condition Browse Module

MeSH Terms

ID	Term
D001749	Urinary Bladder Neoplasms

Ancestor Terms

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000093542	Gemcitabine
D002945	Cisplatin
D000077156	Gefitinib

Ancestor Terms

ID	Term
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides

Browse Leaves

Not provided

Browse Branches

Not provided