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This study has been withdrawn prior to enrollment.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:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00233636
First received: October 4, 2005
Last updated: January 25, 2011
Last verified: January 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00233636     History of Changes
Other Study ID Numbers: 1839IL/0070
Study First Received: October 4, 2005
Last Updated: January 25, 2011
Health Authority: Italy: The Italian Medicines Agency

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, Squamous Cell
Carcinoma
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site

ClinicalTrials.gov processed this record on September 18, 2014