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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT00278460
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed stage IIIB or IV non-small cell lung cancer, including any of the following types:
* Squamous cell carcinoma
* Adenocarcinoma, including bronchoalveolar cell adenocarcinoma
* Large cell anaplastic carcinoma, including giant and clear cell carcinomas
* Histologic or cytologic documentation of recurrence is required
* Measurable or evaluable disease, defined as any mass reproducibly measurable in 2 perpendicular diameters by physical examination or imaging
* The following lesions are not considered measurable or evaluable:
* Bone disease only
* Pleural or pericardial effusions
* Previously irradiated lesions, unless subsequent progression is documented
* CNS metastases allowed provided the patient undergoes at least 2 weeks of radiotherapy prior to study entry
PATIENT CHARACTERISTICS:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Negative pregnancy test
* CALGB performance status ≤ 1
* Life expectancy ≥ 3 months
* Granulocyte count \> 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Creatinine ≤ 2 times normal
* Bilirubin normal
* SGOT and/or SGPT ≤ 2.5 times upper limit of normal (ULN) AND alkaline phosphatase ≤ 1.5 times ULN OR
* Alkaline phosphatase 4 times ULN and SGOT and/or SGPT normal
* Ejection fraction normal by ECHO or MUGA
* No history of congestive heart failure
* No psychiatric illness that would preclude study compliance
* No serious medical or psychiatric illness that would preclude giving informed consent or limit survival to \< 3 months
* No active uncontrolled bacterial, fungal, or viral infection
* No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or breast, basal cell or squamous carcinoma of the skin, or other surgically resected non-recurrent primary tumor not treated with adjuvant radiotherapy or chemotherapy
* No pre-existing peripheral neuropathy ≥ grade 2
PRIOR CONCURRENT THERAPY:
* At least 2 weeks since prior major surgery and recovered from acute effects
* At least 2 weeks since prior palliative radiotherapy and recovered from acute toxic effects
* Any persistent toxicity (e.g., alopecia or hyperpigmentation) not associated with clinical morbidity allowed
* No prior chemotherapy
* No concurrent cranial or thoracic radiation therapy
* No concurrent cytotoxic or hormonal therapy
* Concurrent palliative radiotherapy allowed for relief of localized pain and obstruction
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00278460
Study Brief:
Protocol Section:
NCT00278460