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 @ 9:49 PM
Ignite Modification Date:
2025-12-24 @ 9:49 PM
NCT ID:
NCT00436332
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Biopsy-proven\* bronchioloalveolar carcinoma (BAC) or BAC variants (e.g., adenocarcinoma with BAC features, BAC with invasive adenocarcinoma) meeting the following criteria:
* Incompletely resected or unresectable disease
* No component of squamous cell carcinoma
* Disease staged as 1 of the following:
* Stage IIIB disease (T4 \[cytologically confirmed malignant pleural effusion OR pleural tumor foci that are separate from direct pleural invasion by the primary tumor\], any N, M0)
* Stage IV disease (any T, any N, M1 \[distant metastases present\])
* Recurrent disease in a separate lobe after prior resection within the past 5 years; multifocal lesions in \> 1 lobe; or any disease that is recurrent after surgery or radiotherapy is considered stage IV disease
* Tumor may be multifocal or diffuse NOTE: \*Cytology specimens, including bronchial brushing, washings, or fine needle aspiration specimens, alone are not acceptable for diagnosis
* Measurable or nonmeasurable disease by chest CT scan
* Pleural effusions, ascites, and laboratory parameters are not acceptable as only evidence of disease
* Disease must be present outside field of prior radiotherapy OR a new lesion must be inside port
* Treated brain metastases allowed provided the patient is asymptomatic and do not require steroids
PATIENT CHARACTERISTICS:
* Zubrod performance status 0-2
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Total bilirubin normal
* AST or AST ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
* Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if bone metastases are present)
* Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min
* Urine protein:creatinine ratio ≤ 0.5 OR urine protein \< 1 g by 24-hour urine collection
* Willing to provide prior smoking history
* No hemoptysis ≥ ½ teaspoon within the past 28 days
* No clinical history of pulmonary or upper respiratory hemorrhage \> grade 2 within the past 6 months or \> grade 1 within the past 28 days
* No history of thromboses or hemorrhage, including hemorrhagic or thrombotic stroke, or other CNS bleeding
* No uncontrolled hypertension
* No serious nonhealing wound, ulcer, or bone fracture
* No other prior malignancy except for any of the following:
* Adequately treated basal cell or squamous cell skin cancer
* In situ cervical cancer
* Adequately treated stage I or II cancer that is currently in complete remission
* Any other cancer from which the patient has been disease free for 5 years
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Recovered from prior therapy
* At least 28 days since prior radiotherapy (14 days for palliative radiotherapy)
* At least 28 days since prior surgery (thoracic or other major surgeries)
* More than 7 days since prior fine-needle aspiration or core biopsy
* At least 28 days since prior systemic chemotherapy or biologic therapy
* No prior gefitinib hydrochloride, erlotinib hydrochloride, or bevacizumab
* No other prior anti-epidermal growth factor receptor or anti-vascular endothelial growth factor therapies
* Concurrent stable, therapeutic anticoagulation therapy allowed (i.e., warfarin or low molecular weight heparin), provided the patient has no history of bleeding complications on anticoagulation or an inability to establish a stable therapeutic regimen for anticoagulation
* No other concurrent anticancer therapy, including surgery, chemotherapy, hormone therapy, biologic therapy, or radiotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00436332
Study Brief:
Protocol Section:
NCT00436332