drugset / Trial / NCT01718808

Cetuximab for Elderly Patients With mCRC

NCT01718808 ↗

Phase 2 Terminated 24 enrolled Swiss Cancer Institute
RandomizedParallel-groupOpen-labelTreatment

Summary

OBJECTIVE: The objective of the trial is to judge on the benefit obtained by an upfront cetuximab treatment delivered as monotherapy or as part of a combination treatment with capecitabine in vulnerable elderly patients selected for V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) wild-type and B-type Raf kinase (BRAF) wild-type metastatic colorectal cancer (mCRC).

Timeline

Start
2012-11
Primary completion
2015-12
Completion
2017-01

Outcome

Outcome not reported

Stopped: “FU for 3 years from randomization as initially planned is stopped as we do not expect any changes to the endpoints in the future after one year of FU.”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Capecitabine Small molecule 750 mg/m2 Oral
Comparator Capecitabine Small molecule 1000 mg/m2 Oral
Comparator Cetuximab Monoclonal antibody 500 mg/m2 —

Indications