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.
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
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
Yuri Rukazenkov
Study Director
AstraZeneca