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

NCT00309998 | Completed Phase 2

• 3 other identifiers: CDR0000465498URCC-U1505GENENTECH-AVF3328S
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Median time to disease progression by imaging study every 6 weeks

Secondary Outcomes (3)

• 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

Interventions

bevacizumab BIOLOGICAL

vinorelbine tartrate DRUG

Eligibility Criteria

• Age: 70 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

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

Rochester, New York, 14642-0001, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung; Adenocarcinoma, Bronchiolo-Alveolar

Interventions

Bevacizumab; Vinorelbine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Deepak M. Sahasrabudhe, MD

  James P. Wilmot Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2006
• First Posted: April 3, 2006
• Study Start: September 1, 2005
• Primary Completion: May 1, 2007
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

US (1)