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)
OBJECTIVES:
Primary
- 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.
Secondary
- Determine the feasibility of this regimen in managing patients with unresectable stage
IV gastric adenocarcinoma who have not received prior chemotherapy for metastatic
disease.
- 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.
Interventional
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.
1 year
No
Bach Ardalan, MD
Study Chair
University of Miami Sylvester Comprehensive Cancer Center
United States: Food and Drug Administration
EPROST-20040005
NCT00448682
June 2005
March 2010
Name | Location |
---|---|
University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami, Florida 33136 |