A Phase II Study of Neoadjuvant Gemcitabine and Oxaliplatin in Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma
- To determine the overall 18-month survival of patients with radiographically resectable
pancreatic adenocarcinoma treated with neoadjuvant gemcitabine and oxaliplatin followed
by surgical resection and adjuvant gemcitabine.
- To determine the safety, toxicity, and feasibility of this regimen in the neoadjuvant
- To determine the feasibility of obtaining preoperative core tissue biopsies and the
ability to use these biopsies to establish pathologic correlates of response following
neoadjuvant therapy and to determine if xenografts can be developed from these core
- To determine the specific tumor marker response (CEA and CA19-9) to neoadjuvant
- To determine the prognostic accuracy of serum protein profiles in these patients.
- To determine the overall survival and patterns of tumor recurrence (local vs distant).
- Neoadjuvant therapy: Patients receive gemcitabine IV over 100 minutes and oxaliplatin
IV over 2 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence
of disease progression or unacceptable toxicity.
- Surgery: Within 2-6 weeks after completion of neoadjuvant therapy, patients undergo a
laparoscopy that includes a pancreaticoduodenectomy or distal pancreatectomy with or
- Adjuvant therapy: Beginning 4-16 weeks after surgery, patients receive gemcitabine IV
over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 5 courses in
the absence of disease progression or unacceptable toxicity.
Patients undergo tumor tissue and blood sample collection periodically for correlative
studies. Samples are analyzed for protein expression and tumor markers (CEA and CA19-9) pre-
and post-neoadjuvant therapy via proteomic analysis. Tumor tissue samples are also banked
for research purposes.
After completion of study treatment, patients are followed every 3 months.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival at 18 months
Eileen O'Reilly, MD
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|