drugset / Trial / NCT00227734

Capecitabine and Oxaliplatin With or Without Cetuximab in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery

NCT00227734 ↗

Phase 2 Completed 74 enrolled Swiss Cancer Institute
RandomizedCrossoverOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving capecitabine and oxaliplatin together with cetuximab is more effective than capecitabine and oxaliplatin in treating colorectal cancer. PURPOSE: This randomized phase II trial is studying how well giving capecitabine and oxaliplatin together with cetuximab works compared to capecitabine and oxaliplatin in treating patients with metastatic colorectal cancer that cannot be removed by surgery.

Timeline

Start
2004-06
Primary completion
2005-10
Completion
2006-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cetuximab Monoclonal antibody — Intravenous
Comparator Capecitabine Small molecule 1000 mg/m2 Oral
Comparator Oxaliplatin Small molecule 130 mg/m2 Intravenous

Indications