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 @ 9:30 PM
Ignite Modification Date:
2025-12-24 @ 9:30 PM
NCT ID:
NCT00275132
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed non-small cell lung cancer
* Advanced disease (stage IIIB or IV)
* Diagnosis within 62 days prior to randomization
* Not suitable for first-line chemotherapy, as defined by the following criteria\*:
* ECOG performance status 2-3
* ECOG performance status 0-1 AND creatinine clearance \< 60 mL/min
* NOTE: \*These criteria do not imply that all such patients are unsuitable for chemotherapy; patients are considered unsuitable on a case by case basis
* No symptomatic brain metastases
PATIENT CHARACTERISTICS:
* Estimated life expectancy of at least 8 weeks
* Able to take oral medication
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No severe uncontrolled infection
* No unstable angina
* No myocardial infarction within the past month
* No uncontrolled inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)
* No acute renal failure
* Bilirubin \< 2 times upper limit of normal (ULN)
* Transaminases \< 2 times ULN (5 times ULN if liver metastases are present)
* Creatinine \< 5 times ULN
* No evidence of other significant laboratory finding or uncontrolled medical illness that would interfere with study treatment or results comparison or render the patient at high risk from treatment complications
* No other prior or current malignant disease likely to interfere with study treatment or comparisons
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy
* No prior biological anticancer therapy (e.g., gefitinib, thalidomide, or cetuximab)
* No prior palliative radiotherapy
* Prior palliative radiotherapy to bone metastases allowed within the past 2 weeks
* No concurrent cyclooxygenase-2 inhibitors
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00275132
Study Brief:
Protocol Section:
NCT00275132