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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT00369551
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed non-small cell lung carcinoma (NSCLC) meeting the following criteria:
* The following subtypes are eligible:
* Adenocarcinoma (including bronchoalveolar)
* Large cell carcinoma (including giant and clear cell carcinomas)
* Poorly differentiated carcinoma
* No squamous cell histology
* Unresectable stage II-III disease
* Tumor must not invade the trachea or major arterial or venous structures
* Measurable or evaluable disease
* Measurable disease defined as ? 1 lesion that can be accurately measured in ? 1 dimension as ? 20 mm with conventional techniques or as ? 10 mm with spiral CT scan
* No evidence of CNS disease, including primary brain tumor or brain metastases
* ECOG performance status (PS) 0-1 or Karnofsky PS 60-100%
* Life expectancy \> 6 months
* Granulocyte count ? 1,500/mm³
* Platelet count ? 100,000/mm³
* Bilirubin \< 1.25 times upper limit of normal (ULN)
* AST \< 2.5 times ULN
* Creatinine normalOR creatinine clearance ? 60 mL/min
* FEV\_1 ? 1.0 liters
* 24-hour urine protein \< 1,000 mg (for patients with urine protein:creatinine ratio \[by urine analysis\] \> 1.0)
* No hemoptysis within the past 12 months (defined as bright red blood in sputum of \> 1 teaspoon)
* No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
* No history of allergic reactions attributed to carboplatin or taxane
* No serious or nonhealing wound, ulcer, or bone fracture
* No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
* No significant traumatic injury within the past 14 days
* No clinically significant cardiovascular disease, including any of the following:
* Cerebrovascular accident within the past 6 months
* Uncontrolled hypertension
* Myocardial infarction or unstable angina within the past 6 months
* New York Heart Association class II-IV congestive heart failure
* Serious cardiac arrhythmia requiring medication
* Unstable angina pectoris
* Clinically significant peripheral vascular disease
* No known bleeding diathesis or coagulopathy
* No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
* No uncontrolled intercurrent illness including, but not limited to, the following:
* Ongoing or active infection
* Psychiatric illness or social situations that would limit study compliance
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for ? 6 months after completion of study treatment
* No HIV positivity
* No prior chemotherapy
* No prior epidermal growth factor receptor-targeted therapy
* No prior vascular endothelial growth factor-targeted therapy
* No prior chest radiotherapy
* No major surgery or open biopsy within the past 14 days
* No concurrent treatment with full-dose anticoagulation
* Low-dose anticoagulants (e.g., warfarin) to maintain patency of central venous catheter allowed provided all of the following criteria are met:
* Daily dose of warfarin \< 1 mg
* INR \< 1.5
* No other concurrent investigational agents
* No concurrent major surgical procedures
* No other concurrent anticancer agents or therapies
* No concurrent chronic treatment with aspirin (\> 325 mg daily) or nonsteroidal anti-inflammatory agents
* No dexamethasone as an antiemetic during chemoradiotherapy
* No colony-stimulating factors during chemoradiotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00369551
Study Brief:
Protocol Section:
NCT00369551