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