Page:PARAMOUNT Eli Lilly Informed Consent Document.djvu/12

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Study Procedures (Attachment 1)

Study: H3E-EW-S 124

Study Visit Time Between Visits Approx Visit Length Study Procedures/ Activities
Baseline (Visit 0) 3 hours This visit will determine if you are eligible to participate in this study.
  • Your consent will be requested before you participate in this study
  • Information on your health, medical and smoking history as well as medications you are taking will be collected.
  • Physical exam including measurement of weight, height, blood pressure and pulse will be performed.
  • Radiological exam(s) (CT scan, MRI or chest X-Ray as applicable) will be done.
  • Blood samples will be taken (Up to 15 ml).
  • A urine or blood pregnancy test will be done if you're a woman and could become pregnant during this study.
  • You will also be asked to complete one questionnaire on your health status.

As supportive therapy, you will take folic acid tablets by mouth every day for at least five days before the first administration of study treatment (day 1 of cycle 1). In addition you'll be given vitamin B12 as an intramuscular injection within 7 days prior to day 1 of cycle 1 . The day before the administration of pemetrexed you will also be given dexamethasone or other equivalent corticosteroids by mouth (2 intakes per day).

Visits 1 to 3 Visit 1: Up to 4 weeks after baseline visit Visits 2 to 3: separated by approximately 3 weeks 4 hours At each visit the following tests will be done:
  • Physical exam will be performed; information on your health and about any side effects will be collected.
  • Medications you are taking besides the drug, information on treatment-related hospitalization will be noted.
  • Radiological exam(s) taking a series of pictures of your body (CT scan, MRI or chest X-Ray as applicable) will be done at every other visit (at the end of visit 2).
  • Blood samples will be taken (Up to 15 ml) for routine laboratory tests.
  • You will also be asked to complete one questionnaire on your health status before each infusion of study treatment.
  • Study treatment will be administered
    • pemetrexed will be administered as a 10 minute intravenous infusion. Administration will be repeated every 3 weeks, followed approximately 30 minutes later by
    • an intravenous infusion of cisplatin. You will also receive fluid by infusion before and after the administration of cisplatin.
  • You will continue to take folic acid tablets by mouth daily until 3 weeks after the last dose of pemetrexed. You'll also be given dexamethasone or other corticosteroid twice per day the day before, the day of and the day after each pemetrexed administration. Vitamin B12 injection will be repeated every 3 cycles.
H3W-EW-S124 (b)
Version: 26-October-2009
Page 12 of 14
Confidential