A Phase 2 Study of Cetuximab in Combination With Celecoxib in Colorectal Cancer
- Determine the time to progression in patients with unresectable or metastatic
colorectal cancer treated with cetuximab and celecoxib.
- Determine the response rate, median survival, and 1-year survival rate of patients
treated with this regimen.
- Determine the toxicity profile of this regimen in these patients.
- Determine the feasibility of testing urinary PGE-M in patients treated with this
- Determine the feasibility of testing serum transforming growth factor-α and
amphiregulin in patients treated with this regimen.
- Determine the effects of this regimen on the EGFR pathway in tumor cells (i.e.,
phosphorylated EGFr, phosphorylated AKT, activated mitogen-activated protein kinase).
- Determine the effects of this regimen on the cyclooxygenase-2 pathway in tumor cells by
measuring PGE-2 levels.
OUTLINE: Patients receive cetuximab IV over 1-2 hours once weekly and oral celecoxib twice
daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or
Serum and urine samples are collected at baseline, after week 1, and every other course
thereafter for evaluation of PGE-2 by mass spectrometry, cyclooxygenase-2 activity, and
phospho-EGFR levels by western blot analysis and immunohistochemistry. Samples are also
analyzed for TGF-α and amphiregulin proteomics.
PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free Survival (PFS)
Number of days from study enrollment to evidence of progressive disease radiographically, with progression defined under RECIST criteria as at least 20% increase in sum of longest diameter of target lesions
On study date to off study date in this study with median 9.76 months
Jordan D. Berlin, MD
Vanderbilt-Ingram Cancer Center
United States: Food and Drug Administration
VICC GI 0410
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|