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CompletedNCT00309998Updated Oct 29, 2024

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

A Phase 2 interventional study of bevacizumab and vinorelbine tartrate in Lung Cancer, sponsored by University of Rochester. Completed at 1 site in United States. Open to participants aged 70 Years to 120 Years. Per ClinicalTrials.gov, last updated 2024-10-29.

Sponsored by University of Rochester · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
50
Ages
70 Years to 120 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Lung Cancer

Keywords

  • 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
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 50 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrollment
50 participants (estimated)

Interventions

  • Biologicalbevacizumab
  • Drugvinorelbine tartrate
06

What researchers measure

Primary outcomes

  1. Median time to disease progression by imaging study every 6 weeks

Secondary outcomes

  1. Response rate by imaging study every 6 weeks

  2. Median survival

  3. Safety as measured by toxicity (e.g thromboembolism, bleeding, or bowel perforation) every three weeks or as required

07

Study locations

1 site
  • James P. Wilmot Cancer Center at University of Rochester Medical Center
    Rochester, New York 14642-0001, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00309998
Lead sponsor
University of Rochester
Responsible party
Sponsor
First posted
Apr 3, 2006
Start date
Sep 2005
Primary completion
May 2007
Last update
Oct 29, 2024

Study contacts

Deepak M. Sahasrabudhe, MD
study chair · James P. Wilmot Cancer Center
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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