S0635: Erlotinib and Bevacizumab in Stage IIIB and IV Bronchioloalveolar Carcinoma

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