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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
74
Pemetrexed 500 mg/m2mixed in normal saline 100 mL as a 10 minute IV infusion on day 1 of each 21 day cycle
folic acid 1000 μg daily orally from 7 days prior to treatment initiation until the end of treatment
vitamin B12 1000 μg IM 7 days prior to treatment initiation and the end of treatment
Hallym University Medical Center, Hallym University College of Medicine
Anyang, South Korea
progression free survival
Time between randomization and disease progression or death from any causes, whichever came first. Alive patients free of progression will be censored at the last follow-up
Time frame: Every 9 weeks, from date of randomization until the date of first documented progression upto 24 months
objective response rate
Objective response rate will be measured according to RECIST 1.1
Time frame: every 9 weeks, assess the best overall response from date of randomization until the date of first documented progression upto 24 months
Incidence of treatment-emergent adverse events
Safety assessed per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03
Time frame: every 3 weeks for pemetrexed group, every 9 weeks for observation group from date of randomization until the date of first documented progression upto 24 months
overall survival
Time interval between randomization and death (all causes). Alive patients will be censored at the last date of news or data cut off
Time frame: From date of randomization until the date of death from any cause, assessed up to 1 year after the end of treatment
Quality of Life
QoL will be assessed by EORTC QLQ-C30 core questionaire
Time frame: before randomization, then 9, 18, and 27 weeks after randomization
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Dexamethasone 4 mg twice orally for 3 days beginning the day before treatment until the end of treatment to minimize cutaneous reactions
Keimyeong University Dongsan Medical Center
Daegu, South Korea
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Daejeon, South Korea
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Hwaseong-si, South Korea
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RECRUITING...and 11 more locations