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 @ 3:52 PM
Ignite Modification Date:
2025-12-24 @ 3:52 PM
NCT ID:
NCT00054392
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed non-small cell lung cancer (NSCLC) of 1 of the following types:
* Squamous cell
* Adenocarcinoma
* Large cell anaplastic
* Bronchoalveolar
* Non-small cell carcinoma not otherwise specified NOTE: Mixed tumors are categorized by the predominant cell type (tumors with small-cell anaplastic elements are ineligible)
* Evidence of at least 1 of the following:
* Clinically documented recurrent disease after prior radiation or surgery
* Stage IV disease (distant metastases)
* Stage IIIB disease presenting with 1 of the following:
* Pleural or pericardial effusion by CT scan or chest x-ray
* Pleural implants documented pathologically or seen on CT scan or x-ray
* Measurable or evaluable disease
* No brain metastases unless clinically stable after surgery and/or radiotherapy
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin no greater than 1.5 mg/dL
* AST less than 5 times upper limit of normal
Renal
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 40 mL/min
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No hypersensitivity to agents that contain Cremophor EL (polyoxyethylated castor oil)
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy for advanced NSCLC
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* Recovered from prior radiotherapy
* No prior radiotherapy to the only site of measurable disease, unless the site had subsequent progression of disease documented by physical exam, radiography, or pathology
* No concurrent radiotherapy (except for brain metastases)
Surgery
* See Disease Characteristics
Other
* No concurrent aminoglycoside antibiotics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00054392
Study Brief:
Protocol Section:
NCT00054392