A Phase II Trial of Cetuximab in Unresectable or Metastatic Esophageal and Gastric Carcinoma
Cetuximab will be administered to the patient once weekly until disease progression or
development of toxicity preclude further treatment. One treatment cycle is considered 4
weeks. While receiving cetuximab, the patients' vitals will be monitored weekly, every 4
weeks (1 cycle), bloodwork and a physical exam will be performed and every 8 weeks (2
cycles), reassessment of the tumor and urine pregnancy test for women patients of
childbearing potential will be performed.
All patients will be evaluated by history and physical exam at the end of the study
treatment.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the response rate of cetuximab in patients with advanced esophageal or gastric cancer that has not responded to 1-2 prior chemotherapy regimens given in the metastatic setting
3 years
No
Jennifer Ang Chan, MD
Principal Investigator
Dana-Farber Cancer Institute
United States: Food and Drug Administration
05-113
NCT00130689
July 2005
September 2010
Name | Location |
---|---|
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
North Shore Medical Center Cancer Center | Peabody, Massachusetts 01960 |