Pemetrexed Maintenance in Patients With Urothelial Carcinoma Who Completed First Line Platinum-based Chemotherapy (PREMIER)
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|ClinicalTrials.gov Identifier: NCT03193788|
Recruitment Status : Unknown
Verified May 2017 by JLee, Asan Medical Center.
Recruitment status was: Recruiting
First Posted : June 21, 2017
Last Update Posted : June 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer Ureter Cancer Transitional Cell Carcinoma||Drug: pemetrexed Drug: Folic Acid Drug: Vitamin B12 Injection Drug: Dexamethasone||Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Masking Description:||open label|
|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|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||June 2020|
Experimental: pemetrexed maintenance
Drug: Pemetrexed Maintenance therapy: 500 mg/m^2, IV, on Day 1 of each 21-day cycle until progressive disease or treatment discontinuation.
Drug: folic acid 1000 μg daily orally from 7 days prior to treatment initiation until the end of treatment
Drug: vitamin B12 injection 1000 μg IM 7 days prior to treatment initiation and the every then every 3 cycles until the end of treatment
Drug: dexamethasone 4 mg twice orally for 3 days beginning the day before treatment until the end of treatment
Pemetrexed 500 mg/m2mixed in normal saline 100 mL as a 10 minute IV infusion on day 1 of each 21 day cycle
Other Name: Alimta
Drug: Folic Acid
folic acid 1000 μg daily orally from 7 days prior to treatment initiation until the end of treatment
Drug: Vitamin B12 Injection
vitamin B12 1000 μg IM 7 days prior to treatment initiation and the end of treatment
Other Name: Vitabee 12
Dexamethasone 4 mg twice orally for 3 days beginning the day before treatment until the end of treatment to minimize cutaneous reactions
Other Name: decadron
No Intervention: observation
observation group will be observed with best supportive care until progressive disease
- progression free survival [ Time Frame: Every 9 weeks, from date of randomization until the date of first documented progression upto 24 months ]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
- objective response rate [ Time Frame: every 9 weeks, assess the best overall response from date of randomization until the date of first documented progression upto 24 months ]Objective response rate will be measured according to RECIST 1.1
- Incidence of treatment-emergent adverse events [ 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 ]Safety assessed per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03
- overall survival [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 1 year after the end of treatment ]Time interval between randomization and death (all causes). Alive patients will be censored at the last date of news or data cut off
- Quality of Life [ Time Frame: before randomization, then 9, 18, and 27 weeks after randomization ]QoL will be assessed by EORTC QLQ-C30 core questionaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193788
|Contact: Jae-Lyun Lee, MD, PhD||82 2 3010 firstname.lastname@example.org|
|Contact: MiRan Kim||82 2 3010 email@example.com|
|Principal Investigator:||Jae-Lyun Lee, MD, PhD||Asan Medical Center|