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

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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 also may stop the growth of non-small cell lung cancer 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 IIIB or stage IV primary non-small cell lung cancer who have never smoked.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bevacizumab; Erlotinib Hydrochloride

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