drugset / Trial / NCT00531115
Phase II Study to Evaluate Safety and Efficacy of Cetuximab in Combination With XELOX for 12 Weeks Followed by Maintenance Treatment With Cetuximab Plus Capecitabine as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer.
Phase 2
Terminated
28 enrolled
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Merck Sharp & Dohme LLC · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine confirmed objective response rate to combination therapy with cetuximab plus XELOX for 4 cycles followed by maintenance treatment with cetuximab plus capecitabine as first line treatment in elderly patients with metastatic colorectal cancer
Timeline
- Start
- 2007-11
- Primary completion
- 2009-04
- Completion
- 2009-04
Outcome
Outcome not reported
Stopped: “According to the study design, in the first step the number of responses was lower than the number required (\< 7).”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 750 mg/m2 | — |
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | — |
| Subject | Cetuximab | Monoclonal antibody | 250 mg/m2 | — |
| Subject | Oxaliplatin | Small molecule | 130 mg/m2 | — |