A Phase II Study Of Neo-Adjuvant Chemotherapy And Radiation In Patients With Locally Advanced Pancreatic Cancer
- Determine the antitumor and clinical benefit response to neoadjuvant chemoradiotherapy
comprising gemcitabine, fluorouracil, leucovorin calcium, and oxaliplatin in patients
with potentially resectable locally advanced adenocarcinoma of the pancreas.
- Determine the toxic effects of this regimen in these patients.
- Determine the achieved steady-state plasma levels of gemcitabine and fluorouracil in
these patients and correlate these plasma levels with clinical toxicity associated with
- Determine the potential importance of polymorphic variations in genomic DNA of
pertinent genes (whose protein products are targets of the antineoplastic drugs used in
this study) on response to and toxicity of this regimen in these patients.
- Determine the gene expression profiles of primary and metastatic pancreatic tumors
before and after treatment with this regimen.
- Neoadjuvant chemotherapy: Patients receive gemcitabine IV over 30 minutes and
fluorouracil IV continuously over 24 hours on days 2 and 9, and leucovorin calcium
orally on days 1 and 8 and IV on days 2 and 9. Treatment repeats every 21 days for 2
courses in the absence of disease progression or unacceptable toxicity.
- Neoadjuvant chemoradiotherapy: Beginning on day 42, patients undergo chemoradiotherapy
comprising oxaliplatin IV over 2 hours on days 42, 49, 56, 63, 70, and 77 and
fluorouracil IV continuously on days 42-78 with external beam radiotherapy.
- Surgery: Patients undergo surgical resection 42-56 days after completion of
- Adjuvant chemotherapy: After post-operative recovery, patients receive 2 additional
courses of gemcitabine, fluorouracil, and leucovorin calcium. If surgical resection is
not possible, patients with stable or responsive disease resume gemcitabine,
fluorouracil, and leucovorin calcium indefinitely in the absence of disease progression
or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Antitumor and clinical benefit response
After 6 weeks of chemotherapy and then after 4 weeks of chemo-radiation.
Jean L. Grem, MD
University of Nebraska
United States: Federal Government
|UNMC Eppley Cancer Center at the University of Nebraska Medical Center||Omaha, Nebraska 68198-7680|