Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT00238251
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed non-small cell lung cancer AND newly diagnosed brain metastases meeting 1 of the following criteria:
* Multiple brain metastases
* Single brain metastasis not amenable to potentially curative treatment
* No advanced extracranial disease severely compromising vital functions and performance
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* WHO 0-2
Life expectancy
* Not specified
Hematopoietic
* Hemoglobin \> 10 g/dL
* Absolute neutrophil count \> 1,500/mm\^3
* Platelet count \> 100,000/mm\^3
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST and ALT ≤ 2.5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN in the presence of documented bone metastases)
* No unstable or uncompensated hepatic disease that would preclude study participation
Renal
* Creatinine clearance ≥ 40 mL/min
* No unstable or uncompensated renal disease that would preclude study participation
Cardiovascular
* No myocardial infarction within the past 3 months
* No unstable or uncompensated cardiac disease that would preclude study participation
Pulmonary
* No clinically active interstitial lung disease
* Patients with chronic stable radiographic changes who are asymptomatic eligible
* No other unstable or uncompensated respiratory disease that would preclude study participation
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 12 months after completion of study treatment
* No nausea, vomiting, inability to swallow whole tablets/capsules, or malabsorption syndrome that would preclude oral medication ingestion or absorption
* No psychiatric disorder that would preclude giving informed consent or study compliance
* No active infection
* No uncontrolled diabetes mellitus
* No other medical condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior temozolomide
Endocrine therapy
* Concurrent corticosteroids allowed provided dose has been stable or decreasing for ≥ 4 days before study entry
Radiotherapy
* No prior brain irradiation
Surgery
* Not specified
Other
* No prior gefitinib or erlotinib
* More than 30 days since prior investigational clinical trial participation
* No other concurrent experimental drugs
* No other concurrent anticancer therapy
* No concurrent treatment with any of the following:
* Phenytoin
* Carbamazepine
* Rifampin
* Barbiturates
* Hypericum perforatum (St. John's wort)
* Other enzyme-inducing anti-epileptic drugs or tuberculostatic treatments
* Any drug that contraindicates administration with study drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00238251
Study Brief:
Protocol Section:
NCT00238251