A Phase II Study of Neo-Adjuvant Therapy With Oxaliplatin, Leucovorin, 5-Fluorouracil, Panitumumab (Vectibix) and Radiation in Patients With Locally Advanced Adenocarcinoma of the Esophagus or Gastroesophageal Junction
I. To determine the pathologic complete response rate of a modified FOLFOX-6 regimen
(leucovorin calcium, fluorouracil, and oxaliplatin) given with panitumumab at two-week
intervals x 4 cycles in combination with external beam radiation therapy for patients with
locally advanced adenocarcinoma of the esophagus.
I. To determine the toxicities and ability to complete the planned treatment. II. To
determine the achieved steady-state plasma concentrations of 5-FU (fluorouracil) and
correlate these with clinical toxicity.
III. To assess the potential importance of polymorphic variations in genomic
deoxyribonucleic acid (DNA) of pertinent genes whose protein products are the targets of the
anti-neoplastic drugs used in the clinical protocol on response and toxicity to therapy.
Patients receive panitumumab intravenously (IV) over 1 hour on day 1. Patients also receive
oxaliplatin IV and leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over
46 hours on day 1 (FOLFOX chemotherapy). Treatment repeats every 2 weeks for 4 courses in
the absence of disease progression or unacceptable toxicity. Within 24 hours of the start of
chemotherapy, patients undergo radiation therapy 5 days a week for 5.5 weeks. Patients then
undergo surgery within 6-8 weeks after completion of chemotherapy and radiation therapy.
Patients with residual disease receive 4 additional courses of FOLFOX chemotherapy.
After completion of study treatment, patients are followed up every 3 months.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete pathological response (pCR) rate
Based on the proportion who achieve pCR. Evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 guidelines.
After 4 courses of protocol therapy
University of Nebraska
United States: Food and Drug Administration
|UNMC Eppley Cancer Center at the University of Nebraska Medical Center||Omaha, Nebraska 68198-7680|