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 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT00407550
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
* Stage IIIB (with controlled pleural effusion) OR stage IV disease
* At least 1 measurable lesion whose longest diameter is ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
* No medically significant third-space fluid collection (e.g., ascites or pleural effusions) that cannot be controlled by drainage or other procedures
* No documented brain metastases unless all of the following criteria are met:
* Successful local therapy has been completed
* At least 2 weeks since prior corticosteroids
* Brain imaging required for symptomatic patients only (to rule out brain metastases)
* Concurrent enrollment in clinical trial MCCRC-RC0527 required
PATIENT CHARACTERISTICS:
* Life expectancy ≥ 12 weeks
* ECOG performance status 0-1
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 9.0 g/dL
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 3 times ULN
* AST and ALT ≤ 3 times ULN (5 times ULN for liver involvement)
* Creatinine clearance ≥ 45 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to take folic acid, cyanocobalamin (vitamin B12) supplementation, or dexamethasone and corticosteroids
* Able to interrupt intake of aspirin and nonsteroidal anti-inflammatory agents for a total of 5 days
* No severe and/or uncontrolled medical conditions, including any of the following:
* Hypertension, labile hypertension, or history of poor compliance with antihypertensive medication
* Angina pectoris
* Congestive heart failure within the past 3 months, unless ejection fraction \> 40%
* Myocardial infarction within the past 6 months
* Cardiac arrhythmia
* Diabetes
* Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
* New York Heart Association class III or IV heart disease
* Clinically significant infection
* No other serious medical condition or illness that would preclude study participation
* No peripheral neuropathy ≥ grade 2
* No other malignancy within the past 5 years except nonmelanomatous skin cancer, carcinoma in situ of the cervix, or low-grade (Gleason score ≤ 6) localized prostate cancer
* No significant weight loss (≥ 10%) within the past 6 weeks
* No investigator site personnel directly affiliated with the study, or immediate family (i.e., spouse, parent, child, or sibling, whether biological or legally adopted)
* No employees of Eli Lilly (i.e., employees, temporary contract workers, or designees responsible for conducting the study)
* Immediate family of Eli Lilly employees may participate in Eli Lilly-sponsored clinical trials, but are not permitted to participate at an Eli Lilly facility
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 2 weeks since prior corticosteroids
* At least 4 weeks since prior radiation therapy involving \> 25% of the bone marrow and recovered
* At least 30 days since prior investigational therapy
* No prior radiation therapy to the whole pelvis
* No prior systemic chemotherapy for advanced non-small cell lung cancer
* No prior pemetrexed disodium and/or gemcitabine hydrochloride
* No prior or concurrent sorafenib tosylate and/or temsirolimus
* No concurrent Hypericum perforatum (St. John's wort)
* No other concurrent antitumor therapy
* No concurrent agents that stimulate thrombopoiesis
* Concurrent palliative radiation therapy allowed
* Concurrent corticosteroids allowed for adrenal insufficiency or severe nausea and vomiting
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00407550
Study Brief:
Protocol Section:
NCT00407550