Chemotherapy, Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: Bevacizumab; Pemetrexed; Radiotherapy; Folic Acid; vitamin B12; carboplatin
Intervention description: 15mg/kg week 1, 4, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, 46, and 49.; 500mg/m2 week 1, 4, 16, 19 and 22.; 1.8 Gy single daily fractions(Monday-Friday), to total dose 61.2 Gy (7 weeks); 350 to 1,000 ug or equivalent supplementation administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinues study therapy.; 1,000ug administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinues therapy.; AUC=5 administered intravenously weeks 1 and 4.
Intervention MeSH terms: Folic Acid; Vitamin B 12; Bevacizumab; Carboplatin; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to see if this combination of chemotherapy plus radiation
      therapy and immunotherapy (with bevacizumab) expands treatment options for patients with
      non-small cell lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinically confirmed non-small cell lung cancer stage IIIA and selected stage IIIB

          -  Measurable or evaluable disease

          -  Be up and about and able to care for self

          -  Adequate kidney, liver and bone marrow function

          -  No prior treatment for this disease

          -  Must be able to give written informed consent

          -  Must be able to take folic acid, vitamin B12 and dexamethasone as described in the
             protocol

          -  Age 18 years or older

        Exclusion Criteria:

          -  Stage IV or IIIB patients with pleural or pericardial effusions

          -  Stage IIIB disease with contralateral mediastinal nodes greater than 4cm

          -  Squamous cell predominant tumors

          -  Pregnant or lactating women

          -  Patients with active infections

          -  History of another cancer within the last 5 years with the exception of skin cancer or
             cervical carcinoma in situ

          -  History of stroke, transient ischemic attacks, or acute MI within the past 6 months or
             any other serious cardiovascular disease

          -  Symptoms of peripheral vascular disease

          -  History of neurological disease

          -  Recent history of blood in the sputum or vomitus

          -  Non-healing wounds, ulcer or long bone fractures

          -  History of bleeding problems or coagulation problems

          -  History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess
             within 6 months

          -  History of uncontrolled hypertension

          -  Chronic use of non-steroidal anti-inflammatory medication not allowed on this study

        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. You can then decide if you wish to
        participate.