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 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT00097851
Eligibility Criteria:
Inclusion Criteria:
* histologically or cytologically confirmed stage IIIb or IV NSCLC that has progressed during or after first-line treatment
* measurable disease by spiral CT chest scan, as defined in RECIST criteria
* performance status 0-1 (ECOG)
* life expectancy at least 2 months
* adequate hemopoietic, renal and hepatic function
Exclusion Criteria:
* current symptomatic central nervous system (CNS) involvement
* prior or co-existent malignancies
* significant non-malignant disease
* acute or chronic gastrointestinal (GI) bleeding in last two years
* inflammatory bowel disease
* abnormal bleeding tendency
* patients at risk of bleeding due to open wounds or planned surgery
* clinically significant hemoptysis within the past 4 weeks
* bilirubin \> upper limit of normal (ULN)
* ALT and AST \> 2.5 times ULN, or \> 1.5 times ULN if alkaline phosphatase \> 2.5 times ULN
* alkaline phosphatase \> 5 times ULN, unless patient has bone metastases
* myocardial infarction, stroke or congestive heart failure within last 3 months
* prior treatment with docetaxel
* concomitant treatment with aspirin (\>100 mg/day), NSAIDs (except selective COX-2 inhibitors, warfarin (\>1 mg/day), heparin, LMWH, anti-platelet drugs, CYP3A4 inhibitors
* women who are pregnant or breast-feeding
* women of child-bearing potential not using adequate contraception
* history of allergy and/or hypersensitivity to anti-coagulants or thrombolytic agents, especially heparin
* history of immune-mediated thrombocytopenia, thrombotic thrombocytopenic purpura or other platelet disease
* allergy to polysorbate 80 (component of Taxotere®)
* uncontrolled or serious infection in last 4 weeks
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00097851
Study Brief:
Protocol Section:
NCT00097851