Sunitinib Non Small Cell Lung Cancer Patients Over 70
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Sutent
Intervention description: Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No
Keywords: Untreated NSCLC in patients > 70

Summary:

      The purpose of this research study is to find out what effects (good and bad) sunitinib has
      on patients and their NSCLC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has measurable, metastatic NSCLC, other elderly NSCLC patients over 70 years of age
             who are not felt to be candidates for standard chemotherapy at the discretion of the
             treating physician may also be enrolled as long as they meet the criteria; these
             "special consideration" patients enrollment in the study must be approved by Dr.
             Reynolds or DR. Smith in Dr. Reynolds absence. Patients must have a nonsquamous
             histology to be eligible for this study.

          -  Has not received any prior chemotherapy for the current disease.

          -  Has an ECOG Performance status. Is 70 years of age or older.Has resolution of all
             acute toxic effects of radiotherapy or surgical procedures to NCI CTCAE.

          -  If fertile, patient (males only) has agreed to an acceptable method of birthcontrol to
             avoid pregnancy for the duration of the study and for a period of 2 months thereafter.

          -  Has signed the most recent Patient Informed Consent Form. Has signed a Pate int
             Authorization Form.

        Exclusion Criteria:

          -  Has predominantly squamous NSCLC histology.

          -  Had prior treatment with study drugs or other drugs.

          -  Has a history of hypersensitivity to any component of the study drug. Has any evidence
             of an of antecedent hemoptysis, squamous histology, or ongoing anticoagulation or
             clotting diathesis.

          -  Pre-existing hemoptysis Grade 2, cavitating lesions or clear proximity or involvement
             of blood vessels.

          -  Has had major surgery or radiation therapy within 4 weeks of starting the study
             treatment.

          -  Has had NCI CTCAE (Version 3.0) Grade 3-4 hemorrhage within 4 weeks of starting the
             study treatment.

          -  Has a history of or known spinal cord compression, or carcinomatous meningitis, or
             evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan;
             however, treated, stable, and asymptomatic brain metastases are allowed.

          -  Has had any of the following within the 6 months prior to study drug administration:
             myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
             graft, symptomatic congestive heart failure, cerebrovascular accident or transient
             ischemic attack, or pulmonary embolism. Has ongoing cardiac dysrhythmias of NCI CTCAE
             (Version 3.0) Grade 2.

          -  Has prolonged QTc interval on baseline EKG. Has uncontrolled hypertension.

          -  Has pre-existing thyroid abnormality with thyroid function that cannot be maintained
             in the normal range with medication.

          -  Is receiving concurrent treatment on another clinical trial.

          -  Supportive care trials or non-treatment trials, (eg, QOL), are allowed.

          -  Is receiving concurrent immunotherapy, hormonal therapy, or radiation therapy.

          -  Is receiving concurrent investigational therapy or has received such therapy within
             the past 30 days.

          -  Has a serious uncontrolled intercurrent medical or psychiatric illness, including
             serious infection.

          -  Has a history of other malignancy within the last 5 years (except cured basal cell
             carcinoma of skin and carcinoma in situ of uterine cervix), which could affect the
             diagnosis or assessment of any of the study drugs.

          -  Is unable to comply with requirements of study