Paclitaxel, Bevacizumab and Pemetrexed in Patients With Untreated, Advanced Non-Small Cell Lung Cancer Using Web-Based Data Collection, Patient Self-Reporting of Adverse Effects and Automated Response Assessment
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: Paclitaxel; Pemetrexed; Bevacizumab
Intervention description: Day 1: Paclitaxel (90 mg/m^2 over 60 minutes) Day 15: Paclitaxel (90 mg/m^2 over 60 minutes); Day 1: Pemetrexed (500 mg/m^2 over 10 minutes) Day 15 Pemetrexed (500 mg/m2 over 10 minutes); Day 1:Bevacizumab (10 mg/kg over 20 minutes) Day 15: Bevacizumab (10 mg/kg over 20 minutes)
Intervention MeSH terms: Paclitaxel; Bevacizumab; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: BEVACIZUMAB (AVASTIN); PEMETREXED (ALTIMA); TAXOL (PACLITAXEL); 08-109

Summary:

      The purpose of this study is to determine the percentage of patients with non-small cell lung
      cancer that will experience a shrinkage of their tumors following treatment with three
      medications given together: paclitaxel, pemetrexed (Alimta®), and bevacizumab (Avastin®).
      Each of these medications has been approved by the FDA for patients that have not received
      any treatment for their lung cancer. This study is designed to study the effects of all three
      drugs given at the same time.

      Each of these medications has been studied in lung cancer and is commercially available.
      Paclitaxel and pemetrexed are traditional chemotherapy drugs. Bevacizumab is a monoclonal
      antibody, which means that it attaches to a specific target. Bevacizumab attaches to a
      protein in the blood stream called Vascular Endothelial GrowthFactor (VEGF). VEGF helps
      tumors grow new blood vessels to feed themselves, and bevacizumab is thought to help block
      this new growth of blood vessels and starve the tumors of the nutrients they need.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically confirmed Non-Small Cell Lung Cancer at MSKCC

          -  Clinical stage IIIB or IV.

          -  Measurable disease as per RECIST

          -  Greater than 6 months since receiving neo-adjuvant or adjuvant chemotherapy for
             Non-Small Cell Lung Cancer.

          -  Age ≥ 18 years.

          -  Karnofsky performance status of ≥ to 70.

          -  Marrow and organ function as follows:

          -  WBC ≥ to 4000/mm3

          -  Platelets ≥ to 160,000

          -  Bilirubin ≤ to 1.2mg/dL

          -  Creatinine clearance ≥ to 40mL/min

          -  AST and/or /ALT ≤ 37 Units/L (if one of these elevated, must be ≤ 2.5 ULN)

          -  Systolic blood pressure ≤ to 150mmHg or diastolic blood pressure ≤ to 100 mmHg).

          -  The subject is able to read and comprehend English text from a computer screen.

          -  Women of childbearing potential and sexually active men enrolled in the study must
             agree to practice effective contraception.

        Exclusion Criteria:

          -  Squamous cell carcinoma.

          -  Prior treatment with paclitaxel, pemetrexed or bevacizumab for NSCLC.

          -  Prior systemic anticancer therapy for advanced NSCLC.

          -  Symptomatic brain metastases with evidence of hemorrhage.

          -  Radiation therapy to greater than 25% of the bone marrow within 30 days of starting
             treatment.

          -  Peripheral neuropathy greater than grade 1.

          -  Malignancies within the past 5 years other than non-melanoma skin cancer.

          -  Patients with other serious medical illnesses including, ongoing or active infection,
             symptomatic congestive heart failure, unstable angina pectoris, or psychiatric
             illness/social situations that would limit compliance with study requirements.

          -  History of hemoptysis.

          -  History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess.

          -  History of myocardial infarction or stroke within 6 months prior to enrollment.

          -  Pregnancy or lactation.