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 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
NCT ID:
NCT00066768
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed non-small cell lung cancer
* Stage IIIB\* or IV
* Progressive disease after prior platinum-containing regimen (e.g., cisplatin, carboplatin, or oxaliplatin)
* No known brain or leptomeningeal disease, unless all of the following are true:
* Lesions were previously irradiated
* No concurrent corticosteroids
* No clinical symptoms
* Performance status - ECOG 0-2
* At least 12 weeks
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9.0 g/dL
* Bilirubin no greater than 1.5 mg/dL
* AST/ALT no greater than 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 2.5 times ULN
* Creatinine no greater than 2.0 mg/dL
* No myocardial infarction within the past 6 months
* No congestive heart failure requiring therapy
* No unstable angina
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active serious infectious process
* No grade 2 or greater neuropathy
* No uncontrolled diabetes mellitus
* No psychiatric disorder that would preclude giving informed consent or interfere with study follow-up
* See Disease Characteristics
* At least 28 days since prior cytotoxic chemotherapy and recovered
* No more than 2 prior chemotherapy regimens
* No prior docetaxel
* No prior gemcitabine
* See Disease Characteristics
* See Disease Characteristics
* Prior radiotherapy allowed
* At least 2 weeks since prior epidermal growth factor receptor therapy
* Prior suramin allowed
* No concurrent anti-HIV medications for HIV-positive patients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00066768
Study Brief:
Protocol Section:
NCT00066768