Colorectal Cancer Clinical Trial
Official title:
A Phase II Trial of 5-Fluorouracil Plus 776C85 in Patients With Advanced Resistant Colorectal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Ethynyluracil may help fluorouracil kill more cancer cells by
making tumor cells more sensitive to the drug.
PURPOSE: Phase II trial to study the effectiveness of fluorouracil plus ethynyluracil in
treating patients with advanced colorectal cancer that has not responded to fluorouracil.
OBJECTIVES: I. Assess the confirmed response rate to fluorouracil (5-FU) plus ethynyluracil
(776C85) in patients with metastatic colorectal cancer that has been demonstrated to be
resistant to 5-FU. II. Assess time to progression and survival in this group of patients.
III. Assess the frequency and severity of toxicities associated with this treatment.
OUTLINE: Patients are stratified according to relapse while receiving adjuvant therapy
(relapse within 12 months of completing adjuvant therapy vs relapse while receiving adjuvant
therapy). Patients receive oral doses of ethynyluracil (776C85) and fluorouracil twice daily
for 28 days followed by 1 week of rest. Treatment continues every 5 weeks in the absence of
disease progression or unacceptable toxicity. Patients are followed every 3 months the first
year, every 4 months the second year, and every 6 months thereafter.
PROJECTED ACCRUAL: A total of 35-75 patients will be accrued for this study.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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