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 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
NCT ID:
NCT00073866
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:
* Stage IV
* Stage IIIB with a malignant pleural effusion
* Locally recurrent and/or persistent disease after locoregional therapy with or without systemic chemotherapy
* Unidimensionally measurable disease
* If the only site of measurable disease is in a previously irradiated area must have documented progression of disease in that area
* No CNS metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin normal
* AST and ALT less than 2.5 times upper limit of normal (ULN) (if alkaline phosphatase is normal)
* Alkaline phosphatase less than 4 times ULN (if AST and ALT are normal)
Renal
* Creatinine less than 2.0 mg/dL
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study treatment
* No other malignancy within the past 5 years except curatively treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
* No diagnosis of peptic ulcer disease or gastritis/esophagitis within the past 60 days
* No prior hypersensitivity to cyclooxygenase-2 (COX-2) inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates, sulfonamides, or drugs formulated with polysorbate 80
* No pre-existing grade 2 or greater peripheral neuropathy
* No concurrent medical condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 1 week since prior biologic therapy
* Phase I patients:
* Any number of prior biologic therapies allowed (e.g., chimeric antibodies or kinase inhibitors)
* Phase II patients:
* No prior biologic therapy for recurrent/metastatic disease
* No concurrent filgrastim (G-CSF)
Chemotherapy
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy
* No prior irinotecan or docetaxel
* Phase I patients:
* Up to 2 prior chemotherapy regimens for recurrent/metastatic disease allowed (chemonaïve patients are also eligible)
* Phase II patients:
* At least 1 year since prior adjuvant or neoadjuvant chemotherapy for stage I-IIIA disease
* No prior chemotherapy for recurrent/metastatic disease
Endocrine therapy
* Less than 2 weeks of cumulative oral/IV corticosteroid use within the past 3 months
Radiotherapy
* See Disease Characteristics
* Recovered from prior radiotherapy
* At least 3 weeks since prior extensive-field radiotherapy for recurrent/metastatic disease
Surgery
* Recovered from prior surgery
Other
* More than 60 days since prior treatment for peptic ulcer disease or gastritis/esophagitis
* No prior NSAIDs at a frequency of more than 3 times per week for a cumulative period of more than 2 weeks within the past 30 days
* No concurrent antiepileptics, cyclosporine, aspirin, or fluconazole
* No concurrent NSAIDs
* No other concurrent COX-2 inhibitors
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00073866
Study Brief:
Protocol Section:
NCT00073866