Status:
COMPLETED
Vinorelbine and Bevacizumab in Treating Older Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Lead Sponsor:
University of Rochester
Conditions:
Lung Cancer
Eligibility:
All Genders
70-120 years
Phase:
PHASE2
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 antibodi...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00309998
Start Date
September 1 2005
Last Update
October 29 2024
Active Locations (1)
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1
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642-0001