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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bevacizumab
vinorelbine tartrate
Sponsored by
University of Rochester
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring 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

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

Outcomes

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

Full Information

First Posted
March 29, 2006
Last Updated
September 16, 2014
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT00309998
Brief Title
Vinorelbine and Bevacizumab in Treating Older Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Rochester

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
bevacizumab
Intervention Type
Drug
Intervention Name(s)
vinorelbine tartrate
Primary Outcome Measure Information:
Title
Median time to disease progression by imaging study every 6 weeks
Secondary Outcome Measure Information:
Title
Response rate by imaging study every 6 weeks
Title
Median survival
Title
Safety as measured by toxicity (e.g thromboembolism, bleeding, or bowel perforation) every three weeks or as required

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepak M. Sahasrabudhe, MD
Organizational Affiliation
James P. Wilmot Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
James P. Wilmot Cancer Center at University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642-0001
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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