A Phase II Study of Weekly 24-hour Infusion 5-fluoro-deoxyuridine (FUdR)/Leucovorin With Oxaliplatin and Docetaxel (Taxotere) as First-line Treatment in Patients With Metastatic Gastric Adenocarcinoma (IIT# 14065)
- Determine the overall response rate in patients with unresectable stage IV gastric
adenocarcinoma treated with floxuridine, leucovorin calcium, oxaliplatin, and docetaxel
as first-line treatment.
- Determine the feasibility of this regimen in managing patients with unresectable stage
IV gastric adenocarcinoma who have not received prior chemotherapy for metastatic
- Determine disease-free survival of patients treated with this regimen.
- Evaluate overall survival of patients treated with this regimen.
- Assess the safety and toxicity of this regimen in these patients.
OUTLINE: Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and docetaxel IV over
30 minutes, floxuridine IV over 24 hours, and leucovorin calcium IV over 24 hours on days 1,
8, and 15. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years, every
6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients Achieving Clinical Response
Number of patients achieving complete response (CR) or partial response (PR) according to RECIST Criteria version 1.0.
Bach Ardalan, MD
University of Miami Sylvester Comprehensive Cancer Center
United States: Food and Drug Administration
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