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

NCT ID: NCT00309998

Last Updated: 2024-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30

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.

Conditions

Lung Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

bevacizumab

Intervention Type: BIOLOGICAL

vinorelbine tartrate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 70 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deepak M. Sahasrabudhe, MD

Role: STUDY_CHAIR

James P. Wilmot Cancer Center

Locations

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

Rochester, New York, United States

Countries

United States

Other Identifiers

URCC-U1505

Identifier Type: -

Identifier Source: secondary_id

GENENTECH-AVF3328S

Identifier Type: -

Identifier Source: secondary_id

CDR0000465498

Identifier Type: -

Identifier Source: org_study_id