Bevacizumab (Avastin®) + Erlotinib as First-line Therapy for Stage IIIB/IV or Recurrent, Non-squamous Cell Lung Cancer
Condition: Cancer
Intervention: Bevacizumab and Erlotinib
Intervention description: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
Intervention MeSH terms: Bevacizumab; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      In an attempt to improve the therapeutic index for initial therapy of metastatic NSCLC, the
      combination of bevacizumab and erlotinib is being proposed as first-line treatment in place
      of conventional chemotherapy. This trial is intended to provide pilot data for a future
      randomized trial of this combination of targeted agents versus conventional chemotherapy for
      advanced NSCLC.
    

Eligibility criteria:

        Inclusion Criteria

          -  Histological or cytological diagnosis of non-squamous, non-small cell lung cancer.
             Mixed tumors will be categorized by the predominant cell type unless small cell
             elements are present, in which case the patient is ineligible.

          -  Stage wet IIIB-IV or recurrent disease

          -  No significant hemoptysis (bright red blood< 1/2 teaspoon or more per episode within 3
             months)

          -  Performance status of 0-1

          -  Prior radiation allowed if > 15 days.

          -  No prior treatment for metastatic disease. Adjuvant treatment allowed if greater than
             6 months has passed.

        Exclusion Criteria

        Disease-Specific Exclusions

          -  History of hemoptysis (bright red blood of 1/2 teaspoon or more per episode) within 3
             months prior to study enrollment.

          -  Current, ongoing treatment with full-dose warfarin

          -  Current or recent (within 10 days of enrollment) use of aspirin (>325 mg/day) or
             chronic use of other NSAIDs.

          -  Performance status =2-4

          -  Known HIV-related disease

        General Medical Exclusions

        Subjects meeting any of the following criteria are ineligible for study entry:

          -  Inability to comply with study and/or follow-up procedures

          -  Current, recent (within 4 weeks of the first infusion of this study), or planned
             participation in an experimental drug study other than a Genentech-sponsored
             bevacizumab cancer study

        Bevacizumab (Avastin®)-Specific Exclusions

          -  Inadequately controlled hypertension (defined as systolic blood pressure >150 and/or
             diastolic blood pressure > 100 mmHg on antihypertensive medications)

          -  Any prior history of hypertensive crisis or hypertensive encephalopathy

          -  New York Heart Association (NYHA) Grade II or greater congestive heart failure (see
             Appendix E)

          -  History of myocardial infarction or unstable angina within 6 months prior to study
             enrollment

          -  History of stroke or transient ischemic attack within 6 months prior to study
             enrollment

          -  Significant vascular disease (e.g., aortic aneurysm, aortic dissection)

          -  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 surgical procedure during
             the course of the study

          -  Core biopsy or other minor surgical procedure, excluding 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 as demonstrated by either

          -  Urine protein:creatinine (UPC) ratio > 1.0 at screening OR

          -  Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on
             dipstick urinalysis at baseline should undergo a 24 hour urine collection and must
             demonstrate ≤ 1g of protein in 24 hours to be eligible).

          -  Known hypersensitivity to any component of bevacizumab

          -  Pregnant (positive pregnancy test) or lactating. Use of effective means of
             contraception (men and women) in subjects of child-bearing potential