Clinical trial NCT00684385: An Expanded Access Programme With Iressa for Patients With Non-Small-Cell Lung Cancer and Cancer of the Head and Neck
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)
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Non Small Cell Lung Cancer
Cancer of the Head and Neck
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-05-26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: 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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Freiburg
country: Germany
facility: Research Site
city: Großhansdorf
country: Germany
facility: Research Site
city: Göttingen
country: Germany
facility: Research Site
city: Halle
country: Germany
facility: Research Site
city: Halle
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Kiel
country: Germany
facility: Research Site
city: Laatzen
country: Germany
facility: Research Site
city: Lemgo
country: Germany
facility: Research Site
city: Löwenstein
country: Germany
facility: Research Site
city: Mainz
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Nürnberg
country: Germany
facility: Research Site
city: Oldenburg
country: Germany
facility: Research Site
city: Oldenburg
country: Germany
facility: Research Site
city: Stralsund
country: Germany
facility: Research Site
city: Stuttgart
country: Germany
facility: Research Site
city: Trier
country: Germany
facility: Research Site
city: Wiesbaden
country: Germany
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Kecskemét
country: Hungary
facility: Research Site
city: Törökbálint
country: Hungary
facility: Research Site
city: Gdańsk
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Zabrze
country: Poland
facility: Research Site
city: Newcastle-upon-Tyne
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Yuri Rukazenkov
role: STUDY_DIRECTOR
References: