A Phase 2 interventional study of ethynyluracil and fluorouracil in Colorectal Cancer, sponsored by SWOG Cancer Research Network. Completed at 86 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-08.
Sponsored by SWOG Cancer Research Network · Phase 2, Interventional, and Treatment
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.
5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.
This study's enrollment of 75 is close to the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →SWOG Cancer Research Network is the lead sponsor of 339 studies on the registry; 37 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Drug: ethynyluracil · Drug: fluorouracil
10mg/m2/dose, PO, Days 1-28, q 5wk
Also known as: 776C85
1.0mg/m2/dose, PO, Days 1-28 BID, q 5wk
Also known as: 5-FU
Confirmed Response Rate
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.
Time frame: Once every 10 weeks until off treatment
Progression and Survival
To assess time to progression and survival in this group of patients.
Time frame: Once every 10 weeks until progression
Toxicities
To assess the frequency and severity of toxicities associated with this treatment.
Time frame: Once each week during treatment
The record gives a start of Apr 1998, a primary completion of Nov 2002 and a completion of Oct 2003. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Eniluracil · Fluorouracil
SWOG Cancer Research Network →