Brief Title: Pemetrexed Maintenance in Patients With Urothelial Carcinoma Who Completed First Line Platinum-based Chemotherapy

INTRODUCTION

• Org Study ID: KCSG GU16-05
• Secondary ID: N/A
• NTC ID: NCT03193788
• Sponsor: Asan Medical Center

BRIEF SUMMARY

This study aims to verify superiority of pemetrexed maintenance to observation for patient
without disease progression after 1 st line cisplatin-based chemotherapy.

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DETAILED DESCRIPTION

Patients with unresectable locally advanced, recurrent, or metastatic urothelial carcinoma of
bladder, ureter, or renal pelvis who do not experience disease progression after 4 to 6
cycles of 1 st line chemotherapy administration.

After completion of 4-6 cycles, patients without disease progression on CT which is taken
within 3 weeks after administration of the last chemotherapy will be randomized within 4
weeks after administration of the last chemotherapy to assign either maintenance group or
observation group.

Pemetrexed 500 mg/m 2 mixed in normal saline 100 mL as a 10 minute IV infusion on day 1 of
each 21 day cycle, with vitamin supplementation (folic acid 1000μg daily orally from 7 days
prior to treatment initiation and vitamin B12 1000 μg IM 7 days prior to treatment initiation
and then every 3 cycles). Thereafter, vitamin B12 can be injected on the same day of
pemetrexed infusion. Dexamethasone 4 mg orally twice daily for 3 days beginning the day
before treatment to minimize cutaneous reactions.

Treatment continues until occurrence of disease progression or intolerable toxicities upto
maximum of 16 cycles.

• Overall Status
  Recruiting
• Start Date
  January 2017
• Phase
  Phase 3
• Study Type
  Interventional