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

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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 vinorelbine together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving vinorelbine together with bevacizumab works in treating older patients with stage III or stage IV non-small cell lung cancer.

Detailed Description
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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.

Official Title
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Vinorelbine Plus Bevacizumab as First Line Therapy in Patients ≥ 70 Years of Age With Stage IIIB/IV Non-Squamous, Non-Small Cell Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Biological: bevacizumab
* Drug: vinorelbine tartrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: bevacizumab|nan|
|Drug: vinorelbine tartrate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median time to disease progression by imaging study every 6 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate by imaging study every 6 weeks |  |  | 
| Median survival |  |  | 
| Safety as measured by toxicity (e.g thromboembolism, bleeding, or bowel perforation) every three weeks or as required |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer, large cell lung cancer, recurrent non-small cell lung cancer