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Postoperative Radiotherapy Plus Iressa or Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer (IRESSA&H&N)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00681967
First received: May 20, 2008
Last updated: September 21, 2010
Last verified: September 2010
History of Changes
  Purpose

To evaluate the feasibility and safety of (cohort 1) postoperative standard fractionation radiotherapy plus Iressa and of (cohort 2) hyperfractionated radiotherapy plus cisplatin and Iressa


Condition Intervention Phase
Head and Neck Cancer
 Drug: Gefitinib
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Conventional Postoperative Radiotherapy (Standard Fractionation) Plus Iressa or Hyperfractionated Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer: A Phase I Pilot Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To evaluate the feasibility and safety of (cohort 1) postoperative standard fractionation radiotherapy plus Iressa and of (cohort 2) hyperfractionated radiotherapy plus cisplatin and Iressa [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Both cohorts overall survival (OS) local control (LC) rate at six months and at one year [ Designated as safety issue: No ]
  • Cohort 1 only time-to-recurrence (TTR) [ Designated as safety issue: No ]
  • Cohort 2 only time-to-progression (TTP). Complete Response (CR) rate time to treatment failure (TTF) [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: February 2004
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
post operative combination of gefinib and RT
 Drug: Gefitinib
250 mg; oral
Other Name: IRESSA (TM)
Experimental: Cohort 2
combination of gefitinib with RT and Chemotherapy in non operated patients
 Drug: Gefitinib
250mg; oral
Other Name: IRESSA (TM)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent
  • Age over 18 years
  • Histologically proven squamous cell cancer of the head & neck (SCCHN)
  • Indication for postoperative Radiotherapy: pT3, pT4, pN2b, pN2c, pN3

Exclusion Criteria:

  • Hypersensitivity to ZD1839 or any of the excipients of this product
  • Tumour stage M1
  • Co-existing malignancies diagnosed within the last 5 years. Exceptions: basal cell carcinoma, cervical cancer in situ
  • Absolute neutrophil counts <1.5 x 109
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681967

Locations
Switzerland
Research Site
Basel, Switzerland
Research Site
Bern, Switzerland
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Christoph Rochlitz, Prof Dr med University Hospital of Basel
Study Director: Madeleine Billeter, MD AstraZeneca AG, Grafenau 10; 6300 Zug; Switzerland
Study Chair: Verena Renggli AstraZeneca AG, Grafenau 10; 6300 Zug; Switzerland
  More Information

No publications provided

Responsible Party: Dr. med. Dirk Schneider, AstraZeneca AG Switzerland
ClinicalTrials.gov Identifier: NCT00681967     History of Changes
Other Study ID Numbers: 1839IL/0525
Study First Received: May 20, 2008
Last Updated: September 21, 2010
Health Authority: Switzerland: Swissmedic

Keywords provided by AstraZeneca:
squamous cell cancer of the head & neck
Gefitinib
IRESSA
EGFR Inhibitor
EGFR-tyrosine kinase inhibitor
Subjects with histologically proven squamous cell cancer of the head & neck
Cohort 1:qualifying for postoperative radiotherapy
 (pT3, pT4, pN2b, pN2c, pN3).
Cohort 2:qualifying for definite chemoradiotherapy
(Lateral oropharynx, tonsils: T1N2b-3, T2N1-3, T3any N;
Base of tongue, vallecula: T1N1-3, T2-4 any N; Oral cavity,
glottic and supraglottic larynx; Any TN1-3, T3-4 any N;
Hypopharynx: T1N1-3, T2-4 and N)

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Gefitinib
Cisplatin
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013