NCT03193788

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Bladder Cancer
• Ureter Cancer
• Transitional Cell Carcinoma

Interventions

Type	Name	Description
DRUG	pemetrexed	Pemetrexed 500 mg/m2mixed in normal saline 100 mL as a 10 minute IV infusion on day 1 of each 21 day cycle
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
DRUG	Dexamethasone	Dexamethasone 4 mg twice orally for 3 days beginning the day before treatment until the end of treatment to minimize cutaneous reactions

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-12-01
• Completion: 2020-06-01
• First posted: 2017-06-21
• Last updated: 2017-06-21

Locations

21 sites across 1 country: South Korea