A Study of Thymidylate Synthase Expression in Patients With Non-Small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: pemetrexed; cisplatin
Intervention description: Induction Therapy: 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs; Induction Therapy: 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Thymidylate synthase (TS) is a substance the body produces naturally. The purpose of this
      research is to determine if there is a link between TS production and how well patients
      respond to treatment of non-squamous non-small cell lung cancer (NSCLC). The aim for the
      future is that doctors could have a better understanding in advance about which patients
      might respond well to pemetrexed based on how much TS they produce.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have Stage 3B or 4 Non-Small Cell Lung Cancer of the non- squamous type

          -  Patients must at least be able to be physically mobile, take care of yourself and be
             able to perform light activities such as light housework or office work

          -  Patients must not have had previous chemotherapy treatment for lung cancer

          -  Patients must not have had radiotherapy in the last 30 days

          -  Patients must have measureable tumor lesions according to the Response Evaluation
             Criteria in Solid Tumors (RECIST) guidelines or disease that can be evaluated on
             computed tomography (CT) scan

          -  Patients' test results assessing the function of their blood forming tissue, kidneys,
             liver and lungs are satisfactory

          -  Women must be sterile, postmenopausal or on contraception and men must be sterile or
             on contraception

        Exclusion Criteria:

          -  Patients cannot have received other investigational drugs within the last 30 days

          -  Patients cannot have any serious, uncontrolled medical condition that might compromise
             their ability to take part in the study safely

          -  Patients cannot have a current second primary malignant tumor

          -  Patients cannot be having current treatment with any other anti-tumor therapy

          -  Patients cannot have had a yellow fever vaccination within 30 days of enrolment

          -  Patients who are unable to take vitamins (including injections of vitamin B12) or oral
             cortisone medication

          -  Patients who are unable to stop taking more than 1.3 grams of aspirin on a daily basis
             or non-steroidal anti-inflammatory agents

          -  Patients who are pregnant or breastfeeding