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

Head and Neck Neoplasms Clinical Trial

Official title:

A Phase I/II Trial of ZD1839 (Iressa) Given Concurrently With Cisplatin and Radiotherapy in Patients With Locally Advanced Head and Neck Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00239304
• Other study ID #: 1839IL/0151
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 13, 2005
• Last updated: December 14, 2007
• Start date: June 2003
• Est. completion date: March 2006

Study information

• Verified date: December 2007
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

Drug:
• Gefitinib

• Cisplatin

Procedure:
• Radiotherapy

Locations

Country	Name	City	State
Finland	Research Centre	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parts 1 and 2: Safety (Incidence of DLTs)
Primary	Part 3: Safety and tolerability
Secondary	Parts 2 and 3: Efficacy (Incidence of complete response at 3 months after the end of trial treatment based on RECIST criteria)
Secondary	Exploratory Outcome: EGFR-1 expression, amplification and activation Serum VEGF levels