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 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT00026156
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed, newly diagnosed, advanced primary non-small cell lung cancer (NSCLC) (adenocarcinoma, large cell carcinoma, squamous cell carcinoma, or unspecified), designated as 1 of the following stages:
* Selected stage IIIB (excluding Pancoast tumors)
* T4 lesion due to malignant pleural effusion OR
* Multiple lesions in a single lobe containing a T3 or T4 primary
* Stage IV (any T, any N, M1)
* Recurrent disease after prior surgery and/or radiotherapy
* Measurable or evaluable disease outside of prior radiation port
* No bronchoalveolar carcinoma
* No brain metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Zubrod 0-1 (for age 70 and over) (Age 70 and older with Zubrod 0-1 stratum closed to accrual as of 2/15/2003)
* Zubrod 2 (for age 18 and over)
Life expectancy:
* Not specified
Hematopoietic:
* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than upper limit of normal (ULN)
* SGOT/SGPT no greater than 2 times ULN if alkaline phosphatase is no greater than ULN OR
* Alkaline phosphatase no greater than 4 times ULN if SGOT/SGPT are no greater than ULN
Renal:
* Not specified
Other:
* No prior severe hypersensitivity to docetaxel or other drugs formulated with polysorbate 80
* No grade 2 or greater sensory neuropathy
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer in complete remission
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior or concurrent biologic therapy for NSCLC
* No concurrent filgrastim (G-CSF)
Chemotherapy:
* No prior systemic chemotherapy for NSCLC
Endocrine therapy:
* No prior or concurrent hormonal therapy for NSCLC
Radiotherapy:
* See Disease Characteristics
* At least 3 weeks since prior radiotherapy and recovered
* Concurrent palliative radiotherapy to small-field nonmeasurable lesions (i.e., painful bony lesions) allowed
* No other concurrent radiotherapy
Surgery:
* See Disease Characteristics
* At least 3 weeks since prior thoracic or other major surgery and recovered
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00026156
Study Brief:
Protocol Section:
NCT00026156