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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00309998
Recruitment Status : Completed
First Posted : April 3, 2006
Last Update Posted : September 17, 2014
Information provided by:
University of Rochester

March 29, 2006
April 3, 2006
September 17, 2014
September 2005
May 2007   (Final data collection date for primary outcome measure)
Median time to disease progression by imaging study every 6 weeks
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Complete list of historical versions of study NCT00309998 on Archive Site
  • 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
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Vinorelbine and Bevacizumab in Treating Older Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Vinorelbine Plus Bevacizumab as First Line Therapy in Patients ≥ 70 Years of Age With Stage IIIB/IV Non-Squamous, Non-Small Cell Lung Cancer

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.



  • 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.


  • 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.

Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
Lung Cancer
  • Biological: bevacizumab
  • Drug: vinorelbine tartrate
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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May 2007   (Final data collection date for primary outcome measure)


  • 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


  • 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


  • 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
Sexes Eligible for Study: All
70 Years and older   (Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Deepak M. Sahasrabudhe, James P. Wilmot Cancer Center at University of Rochester Medical Center
University of Rochester
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Study Chair: Deepak M. Sahasrabudhe, MD James P. Wilmot Cancer Center
University of Rochester
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP