drugset / Trial / NCT01522612
Colorectal Cancer (CRC) Cetuximab Elderly Frail
Phase 2
Terminated
5 enrolled
European Organisation for Research and Treatment of Cancer - EORTC
Merck KGaA, Darmstadt, Germany · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
OBJECTIVE: The principal objective of the trial is to evaluate whether the addition of cetuximab associated with 5-fluorouracil in elderly patients with KRAS wild type advanced colorectal cancer (CRC) prolongs Progression Free Survival, compared with 5-fluorouracil alone.
Timeline
- Start
- 2013-04
- Primary completion
- 2015-01
- Completion
- 2015-01
Outcome
Outcome not reported
Stopped (Enrollment): “poor accrual”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | 500 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | 100 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | 200 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |