NCT01769508 - Study of 5-FU, Oxaliplatin, & Lapatinib Combined With Radiation Therapy to Treat HER2 Positive Esophagogastric Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

February 28, 2013

Primary Completion Date

February 28, 2014

Study Completion Date

February 28, 2015

Conditions

HER2 Positive Esophagogastric Cancer

Interventions

DRUG

5-Fluorouracil

5-FU, 225 mg/m2 IVCI, during XRT.

DRUG

Oxaliplatin

Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.

DRUG

Lapatinib

Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion

RADIATION

Radiation Therapy

Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6

Trial Locations (9)

Northeast Georgia Medical Center, Gainesville

Woodlands Medical Specialists, Pensacola

Florida Hospital Cancer Institute, Orlando

Florida Cancer Specialists-North, St. Petersburg

Florida Cancer Specialists - South, Fort Myers

Tennessee Oncology, Nashville

Chattanooga Oncology and Hematology Associates, Chattanooga

Oncology Hematology Care, Cincinnati

Grand Rapids Oncology Program, Grand Rapids