Phase II Bevacizumab, Gemcitabine and Carboplatin in Newly Diagnosed Non-Small Cell Lung Cancer
Condition: Lung Cancer; Non-small Cell Lung Cancer (NSCLC)
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Bevacizumab; Gemcitabine; Carboplatin
Intervention description: Murine humanized anti-vascular endothelial growth factor A (VEGF-A) monoclonal antibody; Nucleoside analog; Alkylating agent
Intervention MeSH terms: Bevacizumab; Carboplatin; Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A multi-center study of bevacizumab in combination with gemcitabine and carboplatin as
      treatment for newly-diagnosed advanced non-small cell lung cancer (NSCLC).
    

Eligibility criteria:

        Inclusion Criteria :

          -  Age 18 or higher

          -  Life expectancy of at least 3 months

          -  ECOG Performance status 0 to 1

          -  Advanced stage non-small cell lung cancer, NSCLC, Stage IIIB with malignant pleural
             effusion or Stage 4, excluding squamous cell histology, with measurable or evaluable
             disease

          -  No prior systemic therapy for advanced NSCLC (prior therapy for early stage disease
             with one regimen is acceptable if it was completed at least 6 months prior to study
             entry)

          -  Palliative radiotherapy to painful bony metastases is permitted prior to study entry
             if completed prior to initiation of study treatment, and there are no residual
             sequelae of therapy such as bone marrow suppression

          -  Willingness to use appropriate contraception to avoid pregnancy during the study

          -  Leukocytes ≥ 3,000/µL

          -  Absolute neutrophil count ≥ 1,500/ µL

          -  Platelets ≥ 100,000/ µL

          -  Total bilirubin within normal institutional limits

          -  AST(SGOT)/ALT(SGPT) ≤ 2.5 x institutional upper limit of normal

          -  Creatinine: Within normal institutional limits

          -  Creatinine clearance ≥ 60 mL/min/1.73 m² for patients with creatinine levels above
             institutional normal

          -  Ability to sign informed consent

        Exclusion Criteria:

          -  Prior systemic treatment for advanced NSCLC (one prior regimen of up to 4 cycles of
             neoadjuvant or adjuvant therapy for early stage disease will be allowed, if completed
             at least 6 months prior to study entry)

          -  Known brain metastases

          -  Prior treatment with bevacizumab

          -  History of allergic reactions

          -  Sensitivity attributed to compounds of similar chemical or biologic composition to
             bevacizumab

          -  Current, recent (within 4 weeks of the first infusion of this study), or planned
             participation in any other experimental drug study

          -  Concomitant chemotherapy, radiotherapy, or investigational agents

          -  Evidence of bleeding diathesis

          -  Coagulopathy

          -  Use of anti-coagulant agents including warfarin, heparin, aspirin, NSAIDs

          -  Pregnant

          -  Lactating

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to Day 0, anticipation of need for major surgical procedure during the course of
             the study

          -  Minor surgical procedures within 7 days prior to day 0

          -  Fine needle aspirations within 7 days prior to day 0

          -  Core biopsies within 7 days prior to day 0

          -  Urine protein: creatinine ratio ≥ 1.0 at screening

          -  History of abdominal fistula within 6 months prior to Day 0

          -  Gastrointestinal perforation within 6 months prior to Day 0

          -  Intra-abdominal abscess within 6 months prior to Day 0

          -  Serious, non-healing wound

          -  Ulcer

          -  Bone fracture

          -  Lung carcinoma of squamous cell histology

          -  Any histology in close proximity to a major vessel

          -  Significant cavitation as assessed by treating investigator in consultation with an
             attending radiologist

          -  History of hemoptysis (bright red blood of 1/2 teaspoon or more)

          -  Blood pressure of > 150/100 mmHg

          -  Unstable angina

          -  New York Heart Association (NYHA) Grade 2 or greater congestive heart failure

          -  History of myocardial infarction within 6 months

          -  History of stroke within 6 months

          -  Clinically significant peripheral vascular disease

          -  Psychiatric illness/social situations that would limit compliance with study
             requirements

          -  Another active malignancy except for non-melanoma skin cancers

          -  Inability to comply with study and/or follow-up procedures