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OpenTrials
Completed

NCT Number: NCT00239304

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

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.

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Key information

Conditions

Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Research Centre

Helsinki, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gefitinib

Drug

Cisplatin

Drug

Radiotherapy

Procedure

Primary outcomes

  1. Parts 1 and 2: Safety (Incidence of DLTs)

  2. Part 3: Safety and tolerability

Secondary outcomes

  1. Parts 2 and 3: Efficacy (Incidence of complete response at 3 months after the end of trial treatment based on RECIST criteria)

  2. Exploratory Outcome: EGFR-1 expression, amplification and activation Serum VEGF levels

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2006
First posted
Oct 17, 2005
Registry last updated
Dec 18, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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