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 @ 3:33 PM
Ignite Modification Date:
2025-12-24 @ 3:33 PM
NCT ID:
NCT00114192
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed non-small cell lung cancer, meeting 1 of the following stage criteria:
* Stage IIIB (with pleural effusion)
* Stage IIIA or IIIB
* Previously treated and not eligible for surgery or definitive thoracic radiotherapy
* Stage IV
* Measurable or evaluable disease
* Documented disease progression during or after standard first-line chemotherapy that may have included taxane
* No untreated brain metastases
* Patients with previously treated brain metastases are eligible provided they have recovered from prior treatment
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count \> 1,500/mm\^3
* Hemoglobin ≥ 8.0 g/dL
* Platelet count \> 100,000/mm\^3
Hepatic
* Bilirubin normal
* SGOT and/or SGPT ≤ 2.5 times upper limit of normal (ULN) AND alkaline phosphatase normal OR
* SGOT and/or SGPT normal AND alkaline phosphatase ≤ 4 times ULN AND no ascites
* Albumin \> 3.0 g/dL
Renal
* Creatinine \< 1.5 mg/dL
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective double-method contraception for 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment
* No HIV positivity
* No peripheral neuropathy \> grade 1
* No other malignancy within the past 5 years except inactive nonmelanoma skin cancer or carcinoma in situ of the cervix or breast
* No active infections
* No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
* No more than 1 prior systemic chemotherapy regimen for locally advanced or metastatic disease
* Prior neoadjuvant or adjuvant systemic chemotherapy allowed
* At least 4 weeks since prior chemotherapy and recovered
Endocrine therapy
* Not specified
Radiotherapy
* Recovered from prior radiotherapy
Surgery
* Not specified
Other
* No other concurrent investigational agents
* No other concurrent anticancer therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00114192
Study Brief:
Protocol Section:
NCT00114192