drugset / Trial / NCT04611724
A Multicenter Prospective Phase II Study of Modified FOLFIRINOX for 1st Line Treatment for Advanced Urachus Cancer
Phase 2
Unknown
35 enrolled
Asan Medical Center
Boryung Pharmaceutical Co., Ltd · collabGreen Cross Corporation · collab
NaSingle-groupOpen-labelTreatment
Summary
This study aims to assess objective response rate of modified FOLFIRINOX in advanced urachaus cancer. Patients with locally advanced, recurrent, or metastatic urachal carcinoma of bladder, urachal will be enrolled this study. Modified version of FOLFIRINOX(Oxaliplatin 85 mg/m 2, Leucovorin 400mg/m2 , irinotecan 150mg/m2 and 5-FU 2400mg/m2) with prophylactic pegateograstim will be continued till progression, unacceptable toxicity, or till 12 cycles (24 weeks). Study drugs can be administered after 12 cycles to the subjects with benefit from study medication. Response evaluation will be done every 6 weeks.
Timeline
- Start
- 2020-12-01
- Primary completion
- 2023-12-31
- Completion
- 2024-09-30
Publications
- Background Ozaka M, Ishii H, Sato T, Ueno M, Ikeda M, Uesugi K, Sata N, Miyashita K, Mizuno N, Tsuji K, Okusaka T, Furuse J. A phase II study of modified FOLFIRINOX for chemotherapy-naive patients with metastatic pancreatic cancer. Cancer Chemother Pharmacol. 2018 Jun;81(6):1017-1023. doi: 10.1007/s00280-018-3577-9. Epub 2018 Apr 9.
- Background Kume H, Tomita K, Takahashi S, Fukutani K. Irinotecan as a new agent for urachal cancer. Urol Int. 2006;76(3):281-2. doi: 10.1159/000091635.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan | Small molecule | 150 mg/m2 | — |
| Subject | Leucovorin | Small molecule | 400 mg/m2 | — |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | — |