First-Line Treatment of A Comparison of 2 Treatments in Elderly Patients With Advanced NSCLC
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: Pemetrexed; Gemcitabine; Bevacizumab; Carboplatin
Intervention description: pemetrexed 500 mg/m2; gemcitabine 1500 mg/m2; bevacizumab 10mg/kg bevacizumab 15mg/kg; carboplatin AUC=5
Intervention MeSH terms: Bevacizumab; Carboplatin; Gemcitabine; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No
Keywords: Non Small Cell Lung Cancer

Summary:

      This trial will look at 2 different drug combinations that have well known safety profiles
      and are known to be active against non small cell lung cancer and combine them with
      bevacizumab, an experimental drug that has shown effectiveness when added to other drug
      combinations for advanced non-small cell lung cancer. The primary objective in this study is
      to see how well this combination of drugs keeps the cancer from getting worse in this elderly
      population of non-small cell lung cancer patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed non-small cell bronchogenic carcinoma, (adenocarcinoma, or
             large cell carcinoma)

          -  Patients who have newly diagnosed unresectable stage III or stage IV disease are
             eligible.

          -  Must be at least 70 years of age

          -  Must have measurable disease by CT scan

          -  Must be able to be up and about and care for themselves

          -  May not have received prior treatment for stage III or IV disease

          -  Must have adequate white and red blood cells and platelets.

          -  Must be able to take Vitamin B12, Folic Acid and dexamethasone as stated in the study

          -  Must be able to understand the nature of this study and give written informed consent

          -  Adequate liver and kidney function

        Exclusion Criteria:

          -  Past or current history of cancer with the exception of treated non- melanoma skin
             cancer or carcinoma in-situ of the cervix, or other cancers cured by local therapy
             alone and have been disease free for five years

          -  Female patients who are pregnant or are lactating are ineligible

          -  History of unstable angina or myocardial infarction within 6 months prior to beginning
             bevacizumab

          -  Brain metastasis - cancer that has spread to the brain

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 6 weeks
             of beginning bevacizumab or anticipation of need for major surgical procedure during
             the course of the study

          -  Full-dose oral or by vein anticoagulation or receiving anti-clotting therapy within 10
             days of starting treatment

          -  Serious nonhealing wound, ulcer, or bone fracture

          -  Bleeding or clotting disorders

          -  Uncontrolled high blood pressure or serious heart arrhythmia requiring medication

          -  History of abdominal fistula, gastrointestinal perforation, or intra- abdominal
             abscess within 6 months prior to beginning bevacizumab

          -  Chronic non-steroidal anti-inflammatory use is not allowed on study

          -  History of stroke or TIAs within the last 6 months

        Please Note: There are additional inclusion/exclusion criteria. The study center will
        determine if you meet all of the criteria. If you do not qualify for the trial, study
        personnel will explain the reasons. If you do qualify, study personnel will explain the
        trial in detail and answer any questions you may have.