Gefitinib (Iressa) in Combo With Chemoradiation in Patien... | NCT00239304

Studies
Gefitinib (Iressa) in Combo With Chemoradiation in Patients With Locally Advanced Head & Neck Cancer

NCT00239304

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Dec 18, 2007Estimated

Enrollment

Phase

Phase 1Phase 2

Conditions

Head and Neck Neoplasms

Interventions

Gefitinib
Cisplatin
Radiotherapy

Countries

Finland

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

Status Module

Record Verification Date

Dec 2007

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

Jun 2003

Primary Completion Date

Not provided

Completion Date

Mar 2006Actual

First Submitted Date

Oct 13, 2005

First Submission Date that Met QC Criteria

Oct 13, 2005

First Posted Date

Oct 17, 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

Dec 14, 2007

Last Update Posted Date

Dec 18, 2007Estimated

Description Module

Brief Summary

To determine the safety and tolerability of gefitinib in combination with cisplatin and radiation (3D-CRT or IMRT) in patients with locally advanced head and neck cancer.

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Parts 1 and 2: Safety (Incidence of DLTs)
Part 3: Safety and tolerability

Secondary Outcomes

Measure	Description	Time Frame
Parts 2 and 3: Efficacy (Incidence of complete response at 3 months after the end of trial treatment based on RECIST criteria)
Exploratory Outcome: EGFR-1 expression, amplification and activation Serum VEGF levels

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed head and neck cancer
Lymph node negative or positive
Metastasis negative
Chemo- and radiotherapy naïve
WHO 0-2
Measurable disease by RECIST
Written informed consent

Exclusion Criteria:

Severe alcohol abuse
Active ILD
Co-existing chronic gastrointestinal disease(s)
Brain metastasis

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 Finland Medical Director, MD	AstraZeneca	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Centre		Helsinki			Finland

Condition Browse Module

MeSH Terms

ID	Term
D006258	Head and Neck Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077156	Gefitinib
D002945	Cisplatin
D011878	Radiotherapy

Ancestor Terms

ID	Term
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Gefitinib	Drug
Cisplatin	Drug
Radiotherapy	Procedure