drugset / Trial / NCT00611858
Cetuximab, 5-FU and Radiation as Neoadjuvant Therapy for Patients With Locally Advanced Rectal Cancer
Phase 2
Terminated
13 enrolled
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center · collabBrigham and Women's Hospital · collabBristol-Myers Squibb · collabMassachusetts General Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
The standard treatment for rectal cancer is to receive the chemotherapeutic drug 5-fluorouracil (5-FU) with radiation therapy before having surgery to remove the rectal cancer. This is known as neoadjuvant chemoradiotherapy. The purpose of this research study is to determine if Cetuximab improves the benefits of neoadjuvant chemoradiotherapy when given with 5-FU and radiation therapy.
Timeline
- Start
- 2008-05
- Primary completion
- 2012-12
- Completion
- 2016-09
Outcome
Outcome not reported
Stopped (Enrollment): “Slow accrual”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | 250 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 225 mg/m2 | Intravenous |