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

This study has been completed.
Sponsor:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00309998
First received: March 29, 2006
Last updated: September 16, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Lung Cancer
Biological: bevacizumab
Drug: vinorelbine tartrate
Phase 2

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Median time to disease progression by imaging study every 6 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate by imaging study every 6 weeks [ Designated as safety issue: No ]
  • Median survival [ Designated as safety issue: No ]
  • Safety as measured by toxicity (e.g thromboembolism, bleeding, or bowel perforation) every three weeks or as required [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: September 2005
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309998

Locations
United States, New York
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642-0001
Sponsors and Collaborators
University of Rochester
Investigators
Study Chair: Deepak M. Sahasrabudhe, MD James P. Wilmot Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Deepak M. Sahasrabudhe, James P. Wilmot Cancer Center at University of Rochester Medical Center
ClinicalTrials.gov Identifier: NCT00309998     History of Changes
Other Study ID Numbers: CDR0000465498, URCC-U1505, GENENTECH-AVF3328S
Study First Received: March 29, 2006
Last Updated: September 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Rochester:
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

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Bevacizumab
Vinorelbine
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on September 18, 2014