Pemetrexed Disodium in Treating Patients With Stage IV Non-small Cell Lung Cancer and ECOG Performance Status 3
Condition: Stage IV Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Laboratory Biomarker Analysis; Pemetrexed Disodium; Quality-of-Life Assessment
Intervention description: Correlative studies; Given IV; QOL studies
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This pilot phase II trial studies how well pemetrexed disodium works in treating patients
      with stage IV non-small cell lung cancer and an Eastern Cooperative Oncology Group (ECOG)
      performance status of 3. Performance status means how well patients are able to perform daily
      activities and care for themselves. Patients with a performance status of 3 have a limited
      ability to move around. Currently, only patients who are able to perform most of their daily
      activities may receive chemotherapy, due to the side effects it may cause. Pemetrexed
      disodium causes fewer side effects than many chemotherapy drugs and may help treat patients
      with stage IV non-small cell lung cancer and a lower performance status.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically confirmed Stage IV non-squamous histology non-small
             cell lung cancer

          -  ECOG performance status of 3

          -  Sensitizing epidermal growth factor receptor (EGFR), anaplastic lymphoma receptor
             tyrosine kinase (ALK) and ROS proto-oncogene 1, receptor tyrosine kinase (ROS-1)
             mutations are either negative or unknown

          -  Absolute neutrophil count >= 1,500/mcL

          -  Platelets >= 100,000/mcL

          -  Creatinine clearance >= 45 mL/min

          -  Women of child-bearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control; abstinence) prior to study entry and for
             the duration of study participation; should a woman become pregnant or suspect she is
             pregnant while participating in this study, she should inform her treating physician
             immediately

          -  Ability to understand and the willingness to sign an Institutional Review Board
             (IRB)-approved informed consent document

          -  Ability to understand and complete the European Organization for Research and
             Treatment of Cancer (EORTC) quality of life (QOL) instruments

        Exclusion Criteria:

          -  Patients who have previously received chemotherapy for non-small cell lung cancer, or
             have received radiotherapy within 2 weeks prior to entering the study, or who have not
             recovered from adverse events due to treatment more than 2 weeks earlier

          -  Patients whose tumors are positive for the sensitizing EGFR mutation

          -  Patients whose tumors are positive for the sensitizing ALK fusion

          -  Patients whose tumors are positive for the sensitizing ROS-1 fusion

          -  Patients may not be receiving any other investigational agents

          -  Patients with symptomatic or recurrent brain metastases should be excluded from this
             clinical trial

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to pemetrexed

          -  Pregnant women are excluded from this study; breastfeeding should be discontinued