We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00681967
First Posted: May 21, 2008
Last Update Posted: September 23, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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
Intervention Model: Single Group Assignment
Masking: None (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:


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

Secondary Outcome Measures:
  • Both cohorts overall survival (OS) local control (LC) rate at six months and at one year
  • Cohort 1 only time-to-recurrence (TTR)
  • Cohort 2 only time-to-progression (TTP). Complete Response (CR) rate time to treatment failure (TTF)

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. med. Dirk Schneider, AstraZeneca AG Switzerland
ClinicalTrials.gov Identifier: NCT00681967     History of Changes
Other Study ID Numbers: 1839IL/0525
First Submitted: May 20, 2008
First Posted: May 21, 2008
Last Update Posted: September 23, 2010
Last Verified: September 2010

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
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action