Phase II Study of Neoadjuvant Gemcitabine/Oxaliplatin and Cetuximab Followed by Surgery or Concurrent External Beam Radiation With Capecitabine for Patients With Locally Advanced Unresectable Nonmetastatic Pancreatic Cancer
- Determine the progression-free survival rate in patients with unresectable, locally
advanced, nonmetastatic adenocarcinoma of the pancreas treated with neoadjuvant therapy
comprising cetuximab, gemcitabine hydrochloride, and oxaliplatin followed by either
surgery or chemoradiotherapy comprising external-beam radiotherapy and capecitabine.
- Determine the toxicity and tolerability of this regimen in these patients.
- Determine overall survival and progression-free survival.
- Determine the response rate in these patients.
- Determine the response duration (defined as the time from first observation response to
the time of progressive disease) in patients who achieve at least a partial response to
- Determine the biomarker response of CA19-9.
OUTLINE: This is an open-label study.
- Neoadjuvant therapy: Patients receive cetuximab IV over 1-2 hours on days 1 and 8,
gemcitabine hydrochloride IV over 100 minutes on day 1, and oxaliplatin IV over 2 hours
on day 2. Treatment repeats every 2 weeks for 6 courses in the absence of disease
progression or unacceptable toxicity.
Patients are evaluated after completion of neoadjuvant therapy. Patients with metastatic
disease are taken off study. Beginning within 4 weeks after completion of neoadjuvant
therapy, patients with resectable disease proceed to surgical resection or chemoradiotherapy
(by choice); patients with unresectable disease proceed to chemoradiotherapy.
- Surgery: Patients undergo surgical resection with the Whipple procedure.
- Chemoradiotherapy: Patients receive oral capecitabine twice daily 5 days a week (on
days 1-5) and undergo external-beam radiotherapy once daily 5 days a week for 5½ weeks.
After completion of study treatment, patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival at 6 months
Andrew S. Kraft, MD
Medical University of South Carolina
United States: Federal Government
|Hollings Cancer Center at Medical University of South Carolina||Charleston, South Carolina 29425|