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Iressa and Radiotherapy in the Treatment of the Locally Advanced Inoperable Squamous Cell Carcinoma of the Head and Neck

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00233636
First Posted: October 6, 2005
Last Update Posted: January 27, 2011
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
The aim of the study is to determine if Iressa added to radiotherapy is effective and safe in shrinking tumour dimensions.

Condition Intervention Phase
Head and Neck Cancer Carcinoma, Squamous Cell Drug: Iressa (Gefitinib) Procedure: Radiotherapy Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 2 Part Phase 2 Trial to Evaluate ZD1839 (Iressa™) & Radiotherapy in Patients w/Locally Advanced Inoperable Squamous Cell Carcinoma of the Head & Neck

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Tumour Response Rate, as complete response (CR) and partial response (PR) . Six months after Last Patient In.

Secondary Outcome Measures:
  • Time to progression, Overall survival, Duration of response. Six months after Last Patient In.

Estimated Enrollment: 28
Study Start Date: July 2003
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically Confirmed locally advanced Squamous Cell Carcinoma of Head and neck
  • At least one measurable tumour lesion

Exclusion Criteria:

  • No previous treatment such as chemotherapy, radiotherapy and/or surgery for Carcinoma Head and Neck
  • No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
  • Any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
  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): NCT00233636


Locations
Italy
Research Site
Aviano, Italy
Research Site
Azienda, Italy
Research Site
Milano, Italy
Research Site
Napoli, Italy
Research Site
Palermo, Italy
Research Site
Ragusa, Italy
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Italy Medical Director, MD AstraZeneca
  More Information

ClinicalTrials.gov Identifier: NCT00233636     History of Changes
Other Study ID Numbers: 1839IL/0070
First Submitted: October 4, 2005
First Posted: October 6, 2005
Last Update Posted: January 27, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
Squamous Cell Carcinoma of Head and Neck
Inoperable locally advanced Squamous Cell Carcinoma of Head and Neck

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action