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Anti-metabolites

Arm 1: Eniluracil/5-FU/Leucovorin for Breast Cancer

Phase 2
Waitlist Available
Research Sponsored by Adherex Technologies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7.5 months
Awards & highlights

Study Summary

The purpose of the study is to determine if eniluracil/5-FU/leucovorin in metastatic breast cancer (MBC) may have efficacy and tolerability advantages over capecitabine monotherapy.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7.5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7.5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival
Secondary outcome measures
To compare the tolerability and toxicity of orally administered eniluracil/5 FU/leucovorin regimen vs. capecitabine monotherapy

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1: Eniluracil/5-FU/LeucovorinExperimental Treatment3 Interventions
Arm 1: (weekly, 28-day cycle): Approximately eighty subjects will orally self-administer eniluracil approximately 13 hr (range of 11-16 hr) before receiving 5 FU and leucovorin. The next day they will orally self-administer 5-FU and leucovorin. On the third day, they will orally self-administer leucovorin. The regimen is taken once per week for three consecutive weeks followed by one-week off-treatment.
Group II: Arm 2: CapecitabineActive Control1 Intervention
Arm 2: (bid daily, 21-day cycle): Approximately sixty subjects will self-administer oral capecitabine (1000 mg/m2) twice daily (12 hr apart) for 14 consecutive days followed by 7 days off-treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leucovorin
FDA approved
Fluorouracil
FDA approved

Find a Location

Who is running the clinical trial?

Adherex Technologies, Inc.Lead Sponsor
9 Previous Clinical Trials
133 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of Eniluracil + 5-Fluorouracil (5-FU) + Leucovorin Versus Capecitabine in Metastatic Breast Cancer
2011. "Study of Eniluracil + 5-Fluorouracil (5-FU) + Leucovorin Versus Capecitabine in Metastatic Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01231802.
All > Metastatic Breast Cancer > Flu
~10 spots leftby May 2025
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