Effect of Iressa With/Without Concurrent Chemoradiotherapy on Tumor Gene Expression Profiles in Patients With Advanced Non-Nasopharyngeal Head and Neck Carcinoma

December 16, 2007 updated by: AstraZeneca

Phase II Study of Iressa With/Without Concurrent Chemoradiotherapy in Patients With Advanced Non-Nasopharyngeal Head and Neck Carcinoma and to Study the Effect of Iressa™ (ZD1839) on Tumour Gene Expression Profiles ®

Two different patient populations will be targeted for this study. The first population (SP1) will include patients with recurrent/metastatic head and neck cancers, excluding salivary gland carcinomas. The second population (SP2) will include treatment-naïve patients with locally advanced squamous cell head and neck cancer (SCHNC).

SP1 will be treated with palliative intent and the patients can be treatment-naïve or have received prior chemotherapy. Study treatment will consist of Iressa (gefitinib) alone.

SP2 will be treated with radical intent. The patients must be treatment-naïve and study treatment will consist of induction Iressa for 3 weeks followed by a combination of Iressa plus cisplatin and concurrent irradiation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed carcinoma of the head and neck (excluding salivary gland and nasopharyngeal carcinoma), namely squamous cell or undifferentiated carcinoma
  • Recurrent/metastatic disease that is not amenable to cure
  • Accessible tumour site for repeat tumour samplings
  • Patients must be agreeable to repeated tumour samplings.
  • Measurable disease sites by computed tomography (CT) imaging is preferred but not mandatory.
  • Adequate performance status of ECOG 0 - 2
  • Life expectancy of at least 3 months
  • Written informed consent to participate in the study

Exclusion Criteria:

  • Prior treatment with tyrosine kinase inhibitor or anti-epidermal growth factor receptor (EGFR) therapy
  • Refusal for repeated tumour samplings
  • Tumour site deemed unsafe for repeated samplings due to risk of bleeding
  • In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (eg. unstable or uncompensated respiratory disorder, cardiac failure, hepatic decompensation, renal failure, uncontrolled metabolic disorders such as diabetes mellitus, or uncontrolled significant infections)
  • Any bleeding disorders
  • Pregnancy or breast-feeding (women of child-bearing potential)
  • Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical carcinoma-in-situ

Inclusion Criteria for SP2:

  • Histologically confirmed carcinoma of the head and neck (excluding salivary gland and nasopharyngeal carcinoma), namely squamous cell carcinoma or undifferentiated carcinoma
  • Locally advanced disease (stage III/IV) without distant metastases, not amenable to curative resection, or patient refusal for surgery
  • Accessible primary site for repeat tumour samplings
  • Patients agreeable to repeated tumour samplings
  • Evaluable and/or measurable disease sites on CT scans
  • Adequate performance status of ECOG 0 - 1
  • Written informed consent to participate in the study

Exclusion Criteria for SP2:

  • Presence of distant metastases
  • Prior treatment with EGFR-targeted therapy, or chemotherapy or radiotherapy to head and neck region
  • Refusal for repeated tumour samplings
  • Tumour site deemed unsafe for repeated samplings due to risk of bleeding
  • Common toxicity criteria (CTC) grade 2 or greater pre-existing motor or sensory neuropathy
  • In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (eg. unstable or uncompensated respiratory disorder, cardiac failure, hepatic decompensation, renal failure, uncontrolled metabolic disorders such as diabetes mellitus, or uncontrolled significant infections)
  • Any bleeding disorders
  • Absolute neutrophil count of less than 1000/mm3, and platelet count of less than 100,000/mm3
  • Serum bilirubin greater than 2 times the upper limit of normal range (ULNR)
  • Serum alanine aminotransferase (ALT) and serum aspartate amino transferase (AST) greater than 2.5 times ULNR
  • Serum creatinine greater than 143 umol/litre
  • Pregnancy or breast-feeding (women of child-bearing potential)
  • Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical carcinoma-in-situ

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To study the effect of Iressa on gene expression profiles in patients with head and neck cancer

Secondary Outcome Measures

Outcome Measure
To study the efficacy of Iressa as monotherapy as first line or after failing prior platinum-based regimen in patients with recurrent/metastatic head and neck carcinomas

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: AstraZeneca Medical Department, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

September 27, 2005

First Submitted That Met QC Criteria

September 27, 2005

First Posted (Estimate)

September 29, 2005

Study Record Updates

Last Update Posted (Estimate)

December 19, 2007

Last Update Submitted That Met QC Criteria

December 16, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1839IL/0547

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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