ACOSOG Z4051: Esophageal Cancer
ACOSOG Z4051: A Phase II Study of Neoadjuvant Therapy With Cisplatin, Docetaxel, Panitumumab Plus Radiation Therapy Followed by Surgery in Patients With Locally Advanced Adenocarcinoma of the Distal Esophagus
Approval Date: 4/8/2010
Principal Investigator: Gary Chmielewski, MD
The goal of this study is to improve the chances that your tumor will shrink and even disappear by adding a special drug to routine chemotherapy and radiation before surgery. This drug is a monoclonal antibody that blocks your tumor from growing and spreading. This drug is called panitumumab.
You will receive panitumumab in combination with two other chemotherapy drugs called cisplatin and docetaxel every 2 weeks for 10 weeks. You also will receive radiation therapy along with the chemotherapy starting week 5.
The monoclonal antibody (panitumumab) being administered in this study is not a commercially marketed product. This means it is not approved by the Food and Drug Administration (FDA) for esophageal cancer. It is FDA approved for treatment of colorectal cancer. Although it is expected to be very similar in safety and activity to similar commercially marketed drugs, it is possible that some differences may exist. Because this is not a commercially marketed drug, panitumumab can only be administered to patients enrolled in this clinical trial.
- Newly diagnosed cancer of the esophagus (adenocarcinoma of the distal esophagus or esophago-gastric junction)
- The tumor must be resectable (meaning that your surgeon will be able to remove the tumor)
- The cancer must not have spread to other parts of the body
- No prior treatment for this cancer (except biopsy)
Status of Clinical Trial:
open and enrolling