S0636: Erlotinib and Bevacizumab in Never-Smokers With Stage IIIB or Stage IV Primary Non-Small Cell Lung Cancer | NCT00445848 | Trialant

S0636: Erlotinib and Bevacizumab in Never-Smokers With Stage IIIB or Stage IV Primary Non-Small Cell Lung Cancer | NCT00445848 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

Adenocarcinoma

No component of squamous cell carcinoma present

Incompletely resected or unresectable disease

Stage IIIB or IV disease as defined below:

Selected 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 lung cancer in a separate lobe after resection or radiotherapy within the past 5 years OR multifocal lesions in > 1 lobe considered stage IV disease

New lesions occurring ≥ 5 years after resection may be considered a separate primary cancer and are not allowed if this is the only focus of lung cancer

Measurable and/or nonmeasurable disease by CT scan, positron emission tomography scan, or MRI

Disease must be present outside a previous radiotherapy field OR a new lesion must be inside the port

Measurable disease must be assessed within the past 28 days

Nonmeasurable disease must be assessed within the past 42 days

Pleural effusions, ascites, and laboratory parameters are not acceptable as the only evidence of disease

Must be a lifelong nonsmoker (< 100 cigarettes in lifetime)

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/mm^3

Platelet count ≥ 100,000/mm^3

Total bilirubin normal

SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present)

Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if bone metastases present)

Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min

Urine protein:creatinine ratio ≤ 0.5 OR urine protein < 1,000 mg by 24-hour urine collection

Not pregnant or nursing

Negative pregnancy test

Fertile patients must use effective contraception

Hypertension allowed if controlled on medication prior to study enrollment

Must be willing to provide prior smoking history

No immediate life-threatening complications from malignancies

No prior major medical condition, psychological condition, or social situation that would preclude study treatment

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 either thrombosis or hemorrhage, including hemorrhagic or thrombotic stroke, or other CNS bleeding

No serious nonhealing wound, ulcer, or bone fracture

No other prior malignancy except for the following:

Adequately treated basal cell or squamous cell skin cancer

Adequately treated stage I or II cancer from which the patient is currently in complete remission

In situ cervical cancer

Any other cancer from which the patient has been disease-free for 5 years

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

At least 7 days since prior fine-needle aspiration or core biopsy

At least 28 days since prior radiotherapy (14 days for palliative radiotherapy) and recovered

At least 28 days since prior surgery (e.g., thoracic or other major surgeries) and recovered

At least 28 days since prior systemic chemotherapy

Prior biologic therapy allowed

No prior gefitinib, erlotinib hydrochloride, bevacizumab, or other targeted therapies against the epidermal growth factor receptor or vascular endothelial growth factor axes

Concurrent stable, therapeutic anticoagulation therapy allowed (e.g., 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 concurrent surgery

No other concurrent nonprotocol treatment (including chemotherapy, hormonal therapy, biological therapy, or radiotherapy) directed at this cancer