Bevacizumab and Docetaxel in Treating Older Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: bevacizumab; docetaxel
Intervention description: Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15
Intervention MeSH terms: Bevacizumab; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 75 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Summary:

      RATIONALE: 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. Drugs used in chemotherapy, such
      as docetaxel, also work in different ways to kill tumor cells or stop them from growing.
      Giving bevacizumab together with docetaxel may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel
      works in treating older patients with stage III or stage IV non-small cell lung cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

        Inclusion criteria:

          -  Histologically or cytologically confirmed non-small cell lung cancer

               -  Stage III or IV disease

                    -  Stage III disease allowed, provided the patient is not a candidate for
                       concurrent chemotherapy and radiotherapy

               -  Mixed histology allowed, provided the biopsy has less than 50% squamous cell
                  histology

          -  Measurable or evaluable disease

        Exclusion criteria:

          -  Squamous cell histology

          -  Evidence of cavitation in the tumor

          -  Tumors in close proximity to major blood vessels

          -  No active, untreated brain metastases

               -  More than 7 days since prior treatment for brain metastases AND no evidence of
                  hemorrhage in the lesion

               -  Stable or declining dose of steroids allowed

        PATIENT CHARACTERISTICS:

        Inclusion criteria:

          -  ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%

          -  Life expectancy > 12 weeks

          -  Leukocytes ≥ 3,000/μL

          -  Absolute neutrophil count ≥ 1,500/μL

          -  Platelet count ≥ 100,000/μL

          -  Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  AST and ALT ≤ 2.5 times ULN (< 5 times ULN if patients has liver metastases)

          -  Creatinine ≤ 1.5 times normal

          -  Left ventricular function ≥ normal by MUGA scan or ECHO

          -  Urine protein:creatinine ratio ≤ 1.0 AND/OR urine protein ≤ 1+ by dipstick analysis OR
             protein ≤ 1 g/24-hour urine collection

          -  Fertile patients must use effective contraception and women should avoid breastfeeding

        Exclusion criteria:

          -  Resting blood pressure (BP) consistently > 140/90 mm Hg

               -  Patients whose BP is controlled (≤ 140 mm Hg systolic and ≤ 90 mm Hg diastolic)
                  after adjusting, starting, or increasing the medications are eligible

          -  Significant hemorrhage (i.e., > 30 mL bleeding/episode ) or hemoptysis (i.e., > 5 mL
             fresh blood in one episode) in the previous 3 months

          -  Evidence of bleeding diathesis or coagulopathy

          -  Significant traumatic injury within the past 28 days

          -  Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the
             past 6 months

          -  History of other active malignancies

               -  If patient has other cancers such as PSA only (without clinical or radiographic
                  evidence) prostate cancer, the patient can still be considered for this protocol
                  if, in the clinical judgment of the treating physician, NSCLC is the most
                  important malignancy and the other malignancy will not impact patient's overall
                  survival

          -  Myocardial infarction or cerebrovascular episode within the past year

          -  Serious nonhealing wound or ulcer

          -  Significant vascular disease such as aortic aneurysm, aortic dissection, or
             symptomatic peripheral vascular disease

          -  Uncontrolled concurrent illness that would limit compliance with study requirements
             including, but not limited to, the following:

               -  Ongoing or active infection

               -  New York Heart Association class II-IV congestive heart failure

               -  Unstable angina pectoris

               -  Cardiac arrhythmia

               -  Psychiatric illness/social situations

          -  Known hypersensitivity to any component of bevacizumab

        PRIOR CONCURRENT THERAPY:

          -  More than 7 days since prior radiotherapy and recovered

          -  No concurrent full-dose warfarin or its equivalent (i.e., unfractionated and/or low
             molecular-weight heparin)

          -  More than 10 days since prior and no concurrent aspirin ≥ 325 mg/day or chronic use of
             nonsteroidal anti-inflammatory drugs

          -  More than 28 days since prior and no concurrent major surgical procedure or open
             biopsy

          -  More than 7 days since prior core biopsy or other minor procedure, excluding placement
             of a vascular access device

          -  No other concurrent investigational agents, commercial agents, or therapies

          -  More than 30 days since prior participation in a trial involving an investigational
             agent

          -  No prior chemotherapy