drugset / Trial / NCT00640081

Combination Chemotherapy and Cetuximab as First-Line Therapy in Treating Patients With Advanced and/or Metastatic Colorectal Cancer

NCT00640081 ↗

Phase 2 Completed 169 enrolled Medical Research Council
RandomizedParallel-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. It is not yet known whether giving combination chemotherapy together with intermittent cetuximab is more effective than combination chemotherapy given together with continuous cetuximab in treating colorectal cancer. PURPOSE: This randomized phase II trial is studying giving combination chemotherapy together with intermittent cetuximab to see how well it works compared to combination chemotherapy given together with continuous cetuximab as first-line therapy in treating patients with advanced or metastatic colorectal cancer.

Timeline

Start
2007-07
Primary completion
2010-06
Completion
2015-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule — Oral
Subject Cetuximab Monoclonal antibody — Intravenous
Subject Leucovorin Small molecule — Intravenous
Subject Oxaliplatin Small molecule — Intravenous
Subject fluorouracil Small molecule — Intravenous

Indications