Bladder Cancer Clinical Trial
Official title:
A Prospective Randomized Phase III Trial of Maintenance Pemetrexed Versus Observation in Patients With Recurrent or Metastatic Urothelial Carcinoma Who Completed First Line Platinum-based Chemotherapy Without Disease Progression
This study aims to verify superiority of pemetrexed maintenance to observation for patient without disease progression after 1 st line cisplatin-based chemotherapy.
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.
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