Erlotinib and Chemotherapy for Patients With Stage IB-IIIA NSCLC With EGFR Mutations (ECON)
Condition: Non Small Cell Lung Cancer; Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: erlotinib; Pemetrexed; Cisplatin; Resection
Intervention description: One tablet daily of erlotinib pills (150 mg daily) for the first 21 days. After surgery, you will be asked to take adjuvant erlotinib 150 mg po daily x 2 years.; pemetrexed 500 mg/m^2 every 3 weeks for 4 cycles treatment) on the first day of each cycle of treatment.; cisplatin 75 mg/m^2 every 3 weeks for 4 cycles treatment) on the first day of each cycle of treatment.
Intervention MeSH terms: Pemetrexed; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lung Cancer; Erlotinib; clinical stage IB-IIIA

Summary:

      The purpose of this study is to try to improve the odds that your cancer may be cured.
      Pemetrexed and cisplatin are traditional chemotherapy drugs that have been shown to help some
      patients with non-small cell lung cancer. Many different types of cancer cells, including
      your type of lung cancer, have a protein on their surface called the epidermal growth factor
      receptor (EGFR). Stimulation of these receptors can result in growth of cancer cells and
      progression of cancer. In addition, your cancer has an EGFR mutation (a specific abnormality
      in the genetic code for EGFR). Erlotinib (TarcevaTM) is a newer drug which has shown benefit
      for patients with lung cancers that contain an EGFR mutation. Erlotinib works by blocking
      this receptor and depriving the cancer cells of this message to grow and multiply. In this
      research study, we plan to combine erlotinib with traditional chemotherapy drugs to see if
      the combination works better than chemotherapy alone.

      The main purpose of this research is to find out the good and bad effects that the
      combination of these 3 drugs (pemetrexed, cisplatin and erlotinib) has when given to patients
      with early stage non-small cell lung cancer before surgery. A secondary purpose is to find
      out the good and bad effects that occur when erlotinib is given to patients after surgery for
      2 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologic confirmation of NSCLC

          -  Patients must have previously untreated stage IB-IIIA NSCLC (T1-3N0-2M0)

          -  Patients must have lung cancer with a documented EGFR activating mutation (exon 19
             deletion, L858R, L861Q)

          -  Patients must be candidates for resection with curative intent

          -  Measurable disease, defined as at least one lesion that can be accurately measured in
             at least one dimension (longest diameter to be recorded on CT)

          -  Age greater or equal to 18 years

          -  Karnofsky performance status greater or equal to 70%

          -  Normal marrow function: leukocytes greater than or equal to 3,000/μl, absolute
             neutrophil count greater than or equal to 1,500/μl, platelets greater than or equal to
             100,000/μl, hemoglobin greater than or equal to 9 gm/dl

          -  Adequate renal function, with creatinine less than or equal to 1.3 mg/dl or calculated
             creatinine clearance greater to or equal to 60ml/min by Cockroft and Gault equation
             using parameters of age, weight (kg), and baseline serum creatinine (mg/dl)

          -  Adequate hepatic function: Total bilirubin within normal limits, AST < 1.5 X UNL,
             alkaline phosphatase < 1.5 X UNL

          -  Women of childbearing age must have a negative urine or blood pregnancy test

          -  Men and women of childbearing potential must be willing to consent to using effective
             contraception while on treatment and for at least 3 months thereafter

          -  Patients must have ability to understand and the willingness to sign a written
             informed consent document

        Exclusion Criteria:

          -  Prior chemotherapy or radiation therapy, with the exception of chemotherapy for
             nononcologic conditions (ie, methotrexate for the treatment of rheumatoid arthritis)

          -  Prior treatment with gefitinib, erlotinib, or other drugs that target EGFR

          -  Patients must not be receiving any other investigational agents

          -  Any evidence of interstitial lung disease (patients with chronic stable radiographic
             changes who are asymptomatic need not be excluded)

          -  Patients who report a hearing deficit at baseline, even if it does not require a
             hearing aid or intervention, or interfere with activities of daily life (CTCAE grade 2
             or higher)

          -  Peripheral neuropathy > grade 1

          -  Known HIV-positive patients receiving combination anti-retroviral therapy are excluded
             from the study because of possible pharmacokinetic interactions with the study drugs.

          -  Other serious illness or medical condition including unstable cardiac disease
             requiring treatment, history of significant neurologic or psychiatric disorders
             (including psychotic disorders, dementia, or seizures), or active uncontrolled
             infection

          -  Women who are pregnant or breast-feeding

          -  Psychiatric illness or social situation that would limit compliance with study
             requirements