SWOG-S9635 Fluorouracil Plus Ethynyluracil in Advanced Colorectal Cancer Not Responded to Fluorouracil
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of 5-Fluorouracil Plus 776C85 in Patients With Advanced Resistant Colorectal Cancer|
- Confirmed Response Rate [ Time Frame: Once every 10 weeks until off treatment ] [ Designated as safety issue: No ]To assess the confirmed response rate to 5-fluorouracil plus 776C85 in patients with measurable, disseminated colorectal cancer that has been demonstrated to be resistant to 5-fluorouracil.
- Progression and Survival [ Time Frame: Once every 10 weeks until progression ] [ Designated as safety issue: No ]To assess time to progression and survival in this group of patients.
- Toxicities [ Time Frame: Once each week during treatment ] [ Designated as safety issue: Yes ]To assess the frequency and severity of toxicities associated with this treatment.
|Study Start Date:||April 1998|
|Study Completion Date:||October 2003|
|Primary Completion Date:||November 2002 (Final data collection date for primary outcome measure)|
Experimental: 776C85 + 5-FU
776C85, 10mg/m2/dose, PO, Days 1-28 (BID), q 5 wk; 5-FU, 1.0mg/m2/dose, PO, Days 1-28 (BID), q 5 wk.
10mg/m2/dose, PO, Days 1-28, q 5wk
Other Name: 776C85Drug: fluorouracil
1.0mg/m2/dose, PO, Days 1-28 BID, q 5wk
Other Name: 5-FU
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.