An Expanded Access Programme With Iressa for Patients With Non-Small-Cell Lung Cancer and Cancer of the Head and Neck - Full Text View

Purpose

The purpose of this study is to provide ZD1839 for those patients with locally advanced and/or metastatic non-operable non-small cell lung cancer (stage III or IV) or recurrent and/or metastatic squamous cell head and neck cancer who receive the therapy on an expanded access basis due to their inability to meet eligibility criteria for on-going recruiting trials, inability to participate in other clinical trials (e.g., poor performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable.

Condition	Intervention	Phase
Non Small Cell Lung Cancer (NSCLC) Cancer of the Head and Neck (H&N)	Drug: ZD1839	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An International Expanded Access Clinical Programme With ZD1839 (IRESSA) for Patients With Advanced Non-small Cell Lung Cancer(NSCLC) and Patients With Recurrent or Metastatic or Both Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck (H&NC)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer Lung Cancer

Drug Information available for: Gefitinib

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

There are no endpoints in this Expanded Access programme. No formal analysis will be performed on any data obtained. All safety data will be tabulated for reporting purposes only. [ Time Frame: There are no endpoints ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	August 2001
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: ZD1839 250mg administered daily for patients with NSCLC and500mg daily for patients with H&NC. Treatment dispensed to patients on Day 1 and every 12 weeks thereafter until the patient withdraws. Patients with NSCLC will take one tablet at each dose administration; patients with squamous cell H&NC will take two tablets at each dose administration. Other Name: Iressa

Eligibility

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

Criteria

Inclusion Criteria:

Have received at least one course of standard systemic chemotherapy or radiation therapy
Are ineligible for chemotherapy or radiotherapy
Are ineligible or not candidates for enrollment in available ZD1839 trials for NSCLC or squamous cell H&NC
Are, in the investigators opinion, not medically suitable for chemotherapy.

Exclusion Criteria:

Current eligibility (i.e., meeting the inclusion and exclusion criteria except signed informed consent) for any ZD1839 protocol available to the patient, or previous enrollment in a blinded ZD1839 protocol
Patients from a blinded protocol may be considered for acceptance, with AstraZeneca's permission, only after trial completion and unblinding of all patients.
Patients eligible for or previously enrolled in an open-label or unblinded ZD1839 clinical trial may be considered for acceptance with AstraZeneca's permission
Incomplete healing from prior oncologic or other major surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00684385

Locations

Germany
Research Site
Berlin, Germany
Research SIte
Essen, Germany
Research Site
Freiburg, Germany
Research Site
Grobhansdorf, Germany
Research Site
Halle, Germany
Research Site
Heidelberg, Germany
Research Site
Lowenstein, Germany
Research Site
Mainz, Germany
Research Site
Munchen, Germany
Research Site
Nurnberg, Germany
Research Site
Oldenburg, Germany
Research Site
Trier, Germany
Hungary
Research Site
Budapest, Hungary
Research Site
Kecskemet, Hungary
Research Site
Torokbalint, Hungary
Poland
Research Site
Gda Sk, Poland
Research Site
Warszawa, Poland
Research Site
Zabrze, Poland

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Alison Armour

AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00684385 History of Changes
Other Study ID Numbers:	1839IL/0052, D7914C00052
Study First Received:	May 21, 2008
Last Updated:	February 9, 2012
Health Authority:	China: Ethics Committee Germany: Ethics Commission Hungary: National Institute of Pharmacy Korea: Food and Drug Administration Portugal: Ethics Committee for Clinical Research Slovakia: State Institute for Drug Control

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013