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

Sponsor

University of Rochester (Other)

Overall Status

Completed

CT.gov ID

NCT00309998

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Biological: bevacizumab Drug: vinorelbine tartrate	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2005

Actual Primary Completion Date :

May 1, 2007

Outcome Measures

Primary Outcome Measures

Median time to disease progression by imaging study every 6 weeks []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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