Phase II Study of Avastin, Irinotecan, High Dose 24 Hour Continuous Intravenous Infusion of Floxuridine and Leucovorin in Patients With Previously Untreated Metastatic Colorectal Cancer
- Determine whether irinotecan hydrochloride, floxuridine, leucovorin calcium, and
bevacizumab improves overall survival of patients with stage IV colorectal cancer.
- Estimate response rate (complete response and partial response), time to response, and
progression-free survival of patients treated with this regimen.
- Estimate the resectability rate in patients treated with this regimen.
- Evaluate the safety and toxicity of this regimen.
- Assess the quality of life of patients treated with this regimen.
OUTLINE: Patients receive bevacizumab IV over 90 minutes on days 1 and 22 and irinotecan
hydrochloride IV over 90 minutes, leucovorin calcium IV over 24 hours, and high-dose
floxuridine IV over 24 hours on days 1, 8, 22, and 29. Treatment repeats every 6 weeks in
the absence of disease progression or unacceptable toxicity. Patients are evaluated after
completion of every 2 courses of therapy. Patients whose disease is deemed operable at
evaluation are referred to surgery.
Patients complete a quality of life assessment at baseline, every 6 weeks during study
treatment, and periodically at follow-up.
After completion of study treatment, patients are followed every 3 months for 6 months,
every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Survival up to 2 Years
Percentage of patients with overall survival times of up to 2 years
Bach Ardalan, 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|