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 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT00006004
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed non-small cell lung carcinoma of any of the following subtypes:
* Squamous cell
* Adenocarcinoma
* Large cell anaplastic
* Bronchioalveolar
* Non-small cell carcinoma not otherwise specified
* No small cell anaplastic elements allowed
* Must have:
* Recurrent disease after prior radiotherapy or surgery OR
* Stage IV disease with distant metastases OR
* Stage IIIB disease presenting with pleural or pericardial effusion on CT or chest x-ray or pleural implants documented pathologically or on CT or chest x-ray
* Bidimensionally measurable or evaluable disease
* Brain metastases allowed provided clinically stable after treatment with surgery and/or radiotherapy
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm3
* Platelet count at least 100,000/mm3
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* SGOT no greater than 5 times upper limit of normal
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 60 mL/min
Cardiovascular:
* No uncontrolled high blood pressure, unstable angina, or congestive heart failure
* No myocardial infarction within the past 6 months
* No serious ventricular arrhythmias requiring medication
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other active malignancies requiring ongoing treatment
* No uncontrolled serious active infections
* No suspected hypersensitivity to agents that utilize Cremophor
* No evidence of neuropathy grade 2 or greater by history or physical examination
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy for non-small cell lung cancer
Endocrine therapy:
* Not specified
Radiotherapy:
* See Disease Characteristics
* No prior radiotherapy to only site of measurable or evaluable disease unless subsequent progression documented by physical exam, radiograph, or pathology
* Recovered from prior radiotherapy
* No concurrent radiotherapy except for whole brain radiation for developing brain metastases
Surgery:
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00006004
Study Brief:
Protocol Section:
NCT00006004