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:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT00575393
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed advanced non-small cell lung cancer
* No known standard therapy for disease that is potentially curative or definitely capable of extending life expectancy
* No symptomatic or worsening CNS metastases despite optimal therapy
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy ≥ 12 weeks
* ANC ≥ 1,500/µL
* Platelet count ≥ 100,000/µL
* Total bilirubin ≤ 2 times upper limit of normal (ULN)
* AST ≤ 3 times ULN (5 times ULN if liver involvement)
* Creatinine ≤ 1.2 times ULN
* Hemoglobin ≥ 9.0 g/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Must be willing to provide blood and tissue samples
* No uncontrolled infection
* No New York Heart Association class III or IV heart disease
* No known allergy to gold sodium thiomalate
PRIOR CONCURRENT THERAPY:
* Recovered from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
* No prior chemotherapy within the past 3 weeks
* No prior mitomycin C or nitrosoureas within the past 6 weeks
* No prior immunotherapy within the past 3 weeks
* No prior biologic therapy within the past 3 weeks
* No prior radiotherapy within the past 3 weeks
* No prior radiotherapy to \> 25% of bone marrow
* No other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (i.e., utilized for a non-FDA-approved indication and in the context of a research investigation)
* No concurrent prophylactic colony stimulating factors
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00575393
Study Brief:
Protocol Section:
NCT00575393