NCT00004195

Brief Summary

RATIONALE: Eniluracil may increase the effectiveness of chemotherapy by blocking tumor enzymes that break down chemotherapy drugs. PURPOSE: Randomized phase II trial to determine the effectiveness of eniluracil followed by surgery in treating patients who have primary or metastatic colorectal cancer.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_2 colorectal-cancer

Timeline
Completed

Started Sep 1998

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1998

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 1999

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2000

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2001

Completed
3.4 years until next milestone

First Posted

Study publicly available on registry

September 16, 2004

Completed
Last Updated

June 15, 2015

Status Verified

June 1, 2015

Enrollment Period

1.1 years

First QC Date

January 21, 2000

Last Update Submit

June 12, 2015

Conditions

Colorectal Cancer

Keywords

stage I colon cancerstage II colon cancerstage III colon cancerstage IV colon cancerstage I rectal cancerstage II rectal cancerstage III rectal cancerstage IV rectal cancerrecurrent colon cancerrecurrent rectal cancer

Outcome Measures

Primary Outcomes (1)

  • Primary Goal to demonstrate that eniluracil at current clinical doses

    To see if at standard clinical doses are capable of inhibiting DPD in Primary and metastatic colorectal cancer in vivo. Since one of the mechanisms of 5-FU(Fluorouracil) tumor resistance is overexpression of DPD,effective inactivation DPD in tumors by eniluracil in this study will be supportive of the use of eniluracil to overcome this type of 5-FU(Fluorouracil) resistance

    Pre-operative and up to 30 days after first dose

Secondary Outcomes (1)

  • Evaluate DPD recovery and uracil levels

    pre-operative and up to 30 post first dose

Other Outcomes (1)

  • Specific Aims

    Duriation of trial up to 30 days after first dose

Study Arms (2)

Oral eniluracil 20 mg twice daily

ACTIVE COMPARATOR

20 mg of eniluracil given twice daily for duration of the study. This subject may have surgery IF tumor is amenable to resection

Drug: eniluracilProcedure: conventional colon surgery

Placebo

PLACEBO COMPARATOR

20 mg placebo that will be given for the duration of the study. This subject may have surgery IF tumor is amenable to resection

Drug: eniluracilProcedure: conventional colon surgery

Interventions

eniluracilDRUG

Will be given to either subject pre-operative and metastatic disease

Also known as: 5 Fu/eniluracil (eli Lilly), 5-fu/eniluracil, 5fu/eniluraci
Oral eniluracil 20 mg twice dailyPlacebo
conventional colon surgeryPROCEDURE

Only if the subject is amenable to surgical resections

Oral eniluracil 20 mg twice dailyPlacebo

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DISEASE CHARACTERISTICS: Histologically proven or suspicious primary or metastatic colorectal carcinoma undergoing disease resection
  • PATIENT CHARACTERISTICS:A. Age: 19 and over
  • Performance status: Karnofsky 60-100%
  • Not pregnant or nursing Fertile patients must use effective contraception during and for at least 1 month after study
  • PRIOR CONCURRENT THERAPY:
  • Subject has had at least 8 weeks since prior fluorouracil, capecitabine, fluorouracil-uracil, floxuridine, or S-1 Endocrine therapy:
  • No prior or concurrent steroids Radiotherapy:
  • Surgery: No prior emergent surgery (e.g., perforation or obstruction) No prior transplantation
  • At least 8 weeks since any prior drug metabolized by dihydropyrimidine dehydrogenase enzyme At least 8 weeks since prior flucytosine

You may not qualify if:

  • Severe infection(White Blood Cell Count)WBC\>2 times normal
  • Fever
  • Sepsis
  • Subject on immunosuppressives therapy
  • Subjects will serum Bilirubin/Creatinine\>2 times normal levels
  • Pregnant /Lactating women
  • Subjects that have received eniluracil or 5-FU(Fluorouracil) within 28 days prior to randomization
  • Subject that have comorbidity illnesses that will increase the likelihood of there death in \<5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

eniluracil

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Martin J. Heslin, MD

    University of Alabama at Birmingham

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Surgical Oncology

Study Record Dates

First Submitted

January 21, 2000

First Posted

September 16, 2004

Study Start

September 1, 1998

Primary Completion

October 1, 1999

Study Completion

May 1, 2001

Last Updated

June 15, 2015

Record last verified: 2015-06