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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

Phase 2
70 Years
Open (Enrolling)
Lung Cancer

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Trial Information

Vinorelbine Plus Bevacizumab as First Line Therapy in Patients ≥ 70 Years of Age With Stage IIIB/IV Non-Squamous, 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.

Inclusion Criteria


- Histologically or cytologically confirmed non-squamous, non-small cell lung cancer

- 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

- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Median time to disease progression by imaging study every 6 weeks

Safety Issue:


Principal Investigator

Deepak M. Sahasrabudhe, MD

Investigator Role:

Study Chair

Investigator Affiliation:

James P. Wilmot Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

September 2005

Completion Date:

Related Keywords:

  • Lung Cancer
  • 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
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642