Pilot Study of Gemcitabine, Oxaliplatin, and Cetuximab for Locally Advanced or Metastatic Pancreatic Cancer
- Determine the progression-free survival of patients with locally advanced or metastatic
pancreatic cancer treated with cetuximab, gemcitabine hydrochloride, and oxaliplatin.
- Determine the complete response and partial response in patients treated with this
- Determine the time to progression in patients treated with this regimen.
- Determine the duration of response in patients treated with this regimen.
- Determine the survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a nonrandomized, open-label, pilot study.
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 2-4 hours on day 2. Treatment repeats
every 14 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The corresponding progression-free survival curve and cumulative risk of progression as a function of time post treatment initiation will be estimated using the Kaplan-Meier method
The cumulative percentage of intent to treat patients who experience disease progression at 1, 2, 3, 4, 5, and 6 months will be characterized with corresponding 95% confidence intervals
Caio Max S. Rocha Lima, MD
University of Miami Sylvester Comprehensive Cancer Center
United States: Food and Drug Administration
|University of Miami Sylvester Comprehensive Cancer Center - Miami||Miami, Florida 33136|