Vinorelbine and Bevacizumab in Treating Older Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

OBJECTIVES:

Primary

• Estimate the median time to disease progression in older patients with non-squamous stage IIIB or stage IV non-small cell lung cancer (NSCLC) treated with vinorelbine ditartate and bevacizumab.

Secondary

• Estimate the response rate in patients treated with this regimen.
• Estimate the median survival in patients treated with this regimen.
• Evaluate the safety of the combination of vinorelbine ditartate and bevacizumab in older patients.

OUTLINE: This is an open-label study.

Patients receive vinorelbine ditartate IV over 6 to 10 minutes on days 1 and 8 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of unacceptable toxicity or disease progression.

After completion of study therapy, patients are followed periodically.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

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

• Stage IIIB (any T, N3, M0 OR T4, any N, M0, OR pleural effusion) OR stage IV (any T, any N, M1) disease
• Mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible
• Measurable or evaluable disease
• No lung carcinoma of squamous cell histology or any histology in close proximity to a major vessel or cavitation
• No known brain metastases, even if treated

PATIENT CHARACTERISTICS:

• No other malignancies within the past 5 years except nonmelanoma skin cancer
• ECOG performance status 0-1
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Bilirubin ≤ 1.5 mg/dL
• Transaminases ≤ 5 times upper limit of normal (ULN)
• Creatinine ≤ 1.5 times ULN
• Urine protein:creatinine ratio < 1
• INR ≤ 1.5
• PTT normal
• No prior ileus or neuropathy compromising use of vinorelbine ditartate
• Patients with a history of hypertension must be well controlled (blood pressure < 150/100 mm Hg) on a stable regimen of antihypertensive therapy
• None of the following conditions:

• Unstable angina
• New York Heart Association grade II-IV congestive heart failure
• Myocardial infarction within the past 6 months
• Stroke within the past 6 months
• Evidence of bleeding diathesis or coagulopathy
• Clinically significant peripheral vascular disease
• Serious, nonhealing wound, ulcer, or bone fracture
• History of hemoptysis (bright red blood ≥ ½ teaspoon)
• No significant traumatic injury within the past 4 weeks
• No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy for NSCLC
• More than 4 weeks since prior and no concurrent participation in another experimental drug study
• More than 4 weeks since prior immunotherapy, hormonal therapy, or radiotherapy and recovered
• More than 28 days since prior major surgical procedure or open biopsy

• No anticipation of need for major surgery during course of trial
• More than 7 days since prior minor surgical procedures (e.g., fine-needle aspiration or core biopsy)
• No concurrent full-dose anticoagulation therapy for thromboembolic disease, aspirin (> 325 mg/day), or nonsteroidal anti-inflammatory drugs