drugset / Trial / NCT03222089
Phase II Trial of FOLFOXIGIL Versus FOLFOXIRI as First-line Therapy in Patients With mCRC
RandomizedParallel-groupOpen-labelTreatment
Summary
A randomized phase II trial of FOLFOXIRI in Combination With GM-CSF and IL-2 (FOLFOXIGIL) Versus FOLFOXIRI as First-line Treatment for Patients With Metastatic Colorectal Cancer.
Timeline
- Start
- 2017-07-20
- Primary completion
- 2019-07-20
- Completion
- 2020-07-20
Outcome
Outcome not reported
Stopped (Enrollment): “Another study enrolling the similar group of patient are ongoing”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GM-CSF | Protein / enzyme biologic | 150 ug | Subcutaneous |
| Subject | IL-2 | Protein / enzyme biologic | 100 iu | Subcutaneous |
| Background | Irinotecan | Small molecule | 165 mg/m2 | Intravenous |
| Background | Levoleucovorin | Unknown | 200 mg/m2 | Intravenous |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2800 mg/m2 | Intravenous |