drugset / Trial / NCT00647530

Fluorouracil and Oxaliplatin With or Without Panitumumab In Treating Patients With High-Risk Colon Cancer That Can Be Removed by Surgery

NCT00647530

Phase 2/3 Unknown 1053 enrolled University of Birmingham
RandomizedParallel-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as fluorouracil and oxaliplatin, 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 panitumumab, 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. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether chemotherapy is more effective with or without panitumumab in treating patients with colon cancer. PURPOSE: This randomized phase III trial assessing whether preoperative chemotherapy and/or an anti-EGFR monoclonal antibody improve outcome in high risk operable colon cancer.

Timeline

Start
2008-05-15
Primary completion
2016-12-23
Completion
2019-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule Oral
Subject Oxaliplatin Small molecule Intravenous
Subject Panitumumab Monoclonal antibody Intravenous
Subject fluorouracil Small molecule Intravenous

Indications