drugset / Trial / NCT02071069
Efficacy and Tolerance of Maintenance Therapy in Patients With Incurable Advanced Colorectal Cancer
NaSingle-groupOpen-labelTreatment
Summary
1. To evaluate efficacy, safety, and feasibility of maintenance therapy with Cetuximab combined with irinotecan or fluorouracil after Cetuximab plus irinotecan and fluorouracil(FOLFIRI) in patients with incurable colorectal cancer. 2. The relevant phase III studies reported that the progression free-survival of cetuximab combined with FOLFIRI in advanced colorectal cancer was 4.3 months up to 6.8 months. This study assumed that the progression free-survival was 5.1 months which was not inferior to the continuous chemotherapy
Timeline
- Start
- 2013-07
- Primary completion
- 2016-05
- Completion
- 2016-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | 250 mg/m2 | — |
| Subject | Cetuximab | Monoclonal antibody | 500 mg/m2 | — |
| Subject | Irinotecan | Small molecule | 180 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |