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 @ 4:29 AM
Ignite Modification Date:
2025-12-25 @ 4:29 AM
NCT ID:
NCT00030420
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of stage IIIA, IIIB, or IV non-small cell lung cancer
* Disease progression during or after 1 or more platinum-based chemotherapy regimens
* Measurable or evaluable disease
* No symptomatic or untreated brain or leptomeningeal metastases
* Previously treated patients must be neurologically stable for 4 weeks after completion of appropriate therapy
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* SWOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 8 g/dL
Hepatic:
* Bilirubin no greater than upper limit of normal (ULN)
* AST/ALT no greater than ULN (or no greater than 2.5 times ULN if alkaline phosphatase no greater than ULN)
* Alkaline phosphatase no greater than ULN (or no greater than 5 times ULN if AST/ALT no greater than ULN)
* No history of chronic hepatitis of any duration
Renal:
* Creatinine no greater than ULN
Cardiovascular:
* No uncontrolled congestive heart failure
* No uncontrolled angina
* No myocardial infarction and/or stroke within the past 6 months
* No active thromboembolic event within the past 4 weeks
Gastrointestinal:
* No gastrointestinal bleeding within the past 6 months
* No history of peptic ulcer disease
Other:
* No prior hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
* No prior allergy to any non-steroidal anti-inflammatory drug
* No other prior or concurrent malignancy within the past 3 years except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
* No grade 2 or greater peripheral neuropathy
* No active infection
* No other serious concurrent medical illness
* No history of dementia, active psychiatric disorder, or other condition that would interfere with ability to take oral medication or preclude compliance with study
* HIV negative
* Must weigh at least 50 kg (110 pounds)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy
* Prior paclitaxel allowed
* No prior docetaxel
Endocrine therapy:
* At least 3 days since prior steroids
Radiotherapy:
* At least 4 weeks since prior radiotherapy
* No prior radiotherapy to target lesion
Surgery:
* At least 4 weeks since prior major surgery
Other:
* Prior intermittent use of non-steroidal anti-inflammatory drugs (NSAIDs), including rofecoxib or celecoxib, allowed
* At least 1 week since prior fluconazole
* No recent prior NSAIDs, including rofecoxib or celecoxib, for a duration of more than 30 consecutive days
* No concurrent fluconazole or lithium
* No other concurrent NSAIDs except aspirin administered at a dose of no more than 325 mg/day for cardiovascular conditions
* No other concurrent cyclo-oxygenase-2 inhibitors
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00030420
Study Brief:
Protocol Section:
NCT00030420