NCT00239304

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2003

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

December 18, 2007

Status Verified

December 1, 2007

First QC Date

October 13, 2005

Last Update Submit

December 14, 2007

Conditions

Head and Neck Neoplasms

Keywords

Stage III Head and Neck CancerStage IV Head and Neck Cancer

Outcome Measures

Primary Outcomes (2)

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

  • Part 3: Safety and tolerability

Secondary Outcomes (2)

  • 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

Interventions

GefitinibDRUG
CisplatinDRUG
RadiotherapyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Centre

Helsinki, Finland

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

GefitinibCisplatinRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTherapeutics

Study Officials

  • AstraZeneca Finland Medical Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 13, 2005

First Posted

October 17, 2005

Study Start

June 1, 2003

Study Completion

March 1, 2006

Last Updated

December 18, 2007

Record last verified: 2007-12

Locations

FI(1)