Carboplatin, Abraxane, and Bevacizumab in Previously Untreated Patients With Advanced Non-Small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: carboplatin; Nab-paclitaxel; Bevacizumab
Intervention description: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles; Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles; IV infusion
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NSCLC; Abraxane; Carboplatin; Bevacizumab; Avastin

Summary:

      The purpose of this research study is to learn more about whether the combination of drugs
      carboplatin, Abraxane and Avastin helps treat non-small cell lung cancer (NSCLC). One of the
      standard treatments for advanced NSCLC is the combination of the drugs carboplatin,
      paclitaxel and Avastin. Paclitaxel can be associated with severe side effects that may make
      the treatment difficult to tolerate. Some of these side effects are caused by the solution
      used to dissolve paclitaxel before it can be administered. Abraxane is a different form of
      paclitaxel that does not need to be dissolved by this solution. Abraxane is approved for the
      treatment of breast cancer but is not approved to treat NSCLC. We will also be trying to
      learn more about how the drug Avastin may work to treat cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed diagnosis of non-small cell lung carcinoma of non-squamous
             histology

          -  AJCC stage IIIB or Stage IV

          -  Measurable disease by RECIST criteria, and must have at least one target lesion 1cm or
             greater in diameter for optimal perfusion CT scanning

          -  No prior chemotherapy treatment or VEGF inhibitor treatment, although prior treatment
             with EGFR inhibitors will be allowed

          -  18 years of age or older

          -  Adequate bone marrow, renal and liver function as outlined in the protocol

        Exclusion Criteria:

          -  Life expectancy of less than 12 weeks

          -  Current, recent (within 4 weeks of the first infusion of this study), or planned
             participation in an experimental drug study

          -  Inadequately controlled hypertension

          -  Any prior history of hypertensive crisis or hypertensive encephalopathy

          -  NYHA Grade II or greater congestive heart failure

          -  History of myocardial infarction or unstable angina within 6 months prior to study
             enrollment

          -  History of stroke, transient ischemic attack within 6 months prior to study enrollment

          -  Symptomatic CNS metastases or newly diagnosed CNS metastases that have not yet been
             definitively treated with radiation and/or surgery. Note that patients with a history
             of CNS metastases or cord compression are allowed if they have been definitively
             treated and are clinically stable. Maintenance steroids are allowed. Two weeks need to
             elapse from the completion of radiation, or 4 weeks from surgery, before starting
             avastin. Patients do have to remain clinically asymptomatic.

          -  Significant vascular disease

          -  Symptomatic peripheral vascular disease

          -  Evidence of bleeding diathesis or coagulopathy

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to study enrollment or anticipation of need for major medical surgical procedure
             during the course of the study

          -  Minor surgical procedure, excluding FNA, core biopsy or placement of a vascular access
             device, within 7 days prior to study enrollment

          -  History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
             within 6 months prior to study enrollment

          -  Serious, non-healing wound, ulcer, or bone fracture

          -  Proteinuria at screening

          -  Pregnant or lactating

          -  Lung carcinoma of squamous cell histology

          -  History of hemoptysis within 3 months prior to study enrollment

          -  Current, on-going treatment with full-dose warfarin or its equivalent at the onset of
             treatment

          -  Current or recent (within 10 days of enrollment) use of aspirin or chronic use of
             other NSAIDs