A Phase II Of An Optimized LV-5FU-Oxaliplatin Strategy With Celebrex In Metastatic Colorectal Cancer, Optimox2-Celecoxib Study
- Determine the response rate in patients with metastatic colorectal cancer treated with
celecoxib, leucovorin calcium, fluorouracil, and oxaliplatin.
- Determine the toxicity of this regimen in these patients.
- Determine the time of disease control to evaluate progression-free survival in patients
treated with this regimen.
- Determine the salvage surgery rate in patients treated with this regimen.
- Determine the duration of chemotherapy-free intervals in patients treated with this
- Determine the tolerability of this regimen in these patients.
- Determine the quality of life of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive FOLFOX7 chemotherapy comprising oxaliplatin IV over 2 hours and leucovorin
calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours beginning on day 1.
Patients also receive oral celecoxib twice daily beginning on day 1. Treatment repeats every
14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients with stable or responding disease stop treatment. If disease progression occurs
during the chemotherapy-free interval, patients receive an additional 6 courses.
Patients with responding disease after receiving at least 6 courses of chemotherapy may
undergo surgery. Beginning within 10 weeks after surgery, patients receive simplified LV5FU2
chemotherapy comprising leucovorin calcium IV over 2 hours on day 1, fluorouracil IV over 46
hours beginning on day 1, and oral celecoxib twice daily beginning on day 1. Treatment
repeats every 14 days for at least 12 courses.
Quality of life is assessed at baseline, during courses 4 and 6, and then every 2 months
Patients are followed at 1 month and then every 2 months thereafter.
PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Thierry Andre, MD
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
United States: Federal Government