A Phase II Trial of the Combination of OSI-774 (ERLOTINIB; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) and Adenocarcinoma With BAC Features (ADENOBAC)
A Phase II Trial of the Combination of OSI-774 (ERLOTINIB; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) and Adenocarcinoma With BAC Features (ADENOBAC)
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving erlotinib together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving erlotinib together with bevacizumab works in treating patients with stage III or stage IV non-small cell lung cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib hydrochloride once daily on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for up to 2 years.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
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])
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
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:
Not pregnant or nursing
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Marysville, California 95901, United States
San Francisco, California 94115, United States
Santa Clara, California 95051, United States
South San Francisco, California 94080, United States
Hartford, Connecticut 06105, United States
Maywood, Illinois 60153, United States
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Lexington, Kentucky 40536-0093, United States
Dearborn, Michigan 48123-2500, United States
Grosse Pointe Woods, Michigan 48236, United States
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Murray, Utah 84157, United States
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