Page:PARAMOUNT Eli Lilly Informed Consent Document.djvu/13

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Visit 4 Approximately 3 weeks after visit 3 4 hours At this 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 4).
  • 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.
  • The physical exam and radiological tests performed at the end of visit 4 will determine if you're eligible to receive the second part of the treatment. If you are eligble, you will be assigned to 1 of the 2 treatments: pemetrexed + Best Supportive Care or Placebo + Best Supportive Care. Best Supportive Care is defined as treatment given to maximize quality of like without the intention of curing your cancer or slowing it's growth.
Visits 5 and following ones separated by approximately 3 weeks 2 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) (CT scan, MRI or chest X-Ray as applicable) will be done at every other visit.
  • 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
    • If you're assigned to the pemetrexed + Best Supportive Care treatment, pemetrexed will be administered as a 10 minute intravenous infusion. Administration will be repeated every 3 weeks.
    • If you're assigned to the Placebo + Best Supportive Care treatment, a salt solution will be administered as a 10 minute Intravenous infusion in place of pemetrexed.
  • You will continue to take folic acid tablets by mouth daily until 3 weeks after the last dose of study treatment. You'll also be given dexamethasone or other corticosteroid twice per day the day before, the day of and the day after each administration of study treatment. Vitamin B12 injection will be repeated every 3 cycles.
H3W-EW-S124 (b)
Version: 26-October-2009
Page 13 of 14
Confidential