drugset / Trial / NCT00580073

Phase II Trial of Neoadjuvant FOLFOX4 and Cetuximab for Localized Adenocarcinoma of Rectum

NCT00580073 ↗

NaSingle-groupOpen-labelTreatment

Summary

This study involves the use of Oxaliplatin, 5-Fluorouracil (5-FU), Leucovorin and Cetuximab, which are all medicines approved by the Food and Drug Administration (FDA) and are commercially available. This treatment regimen will possibly be combined with radiation before and/or after surgery depending on your response to the treatment. Their use in this exact combination is considered experimental. The purpose of this study is to find out how effective this combination of chemotherapy is as treatment for rectal cancer that has not spread to other parts of the body. The side effects and survival experienced by subjects receiving these drugs will also be evaluated. This is a phase II research study.

Timeline

Start
2007-12
Primary completion
2009-11
Completion
2009-11

Outcome

Outcome not reported

Stopped (Business): “Loss of funding”

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 250 unknown —
Subject Cetuximab Monoclonal antibody 400 mg/m2 —
Subject Leucovorin Small molecule 200 mg/m2 —
Subject Oxaliplatin Small molecule 85 mg/m2 —
Subject fluorouracil Small molecule 400 mg/m2 —
Subject fluorouracil Small molecule 600 mg/m2 —

Indications