NCT00003873

Brief Summary

Randomized phase III trial to compare the effectiveness of fluorouracil given by infusion with that of fluorouracil plus eniluracil given by mouth in treating patients who have metastatic, recurrent, or residual advanced colorectal cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if fluorouracil is more effective with or without eniluracil for advanced colorectal cancer

Trial Health

80
On Track

Trial Health Score

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

Enrollment
950

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1999

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.7 years until next milestone

First Posted

Study publicly available on registry

July 16, 2004

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

8.3 years

First QC Date

November 1, 1999

Last Update Submit

January 23, 2013

Conditions

Adenocarcinoma of the ColonAdenocarcinoma of the RectumRecurrent Colon CancerRecurrent Rectal CancerStage IV Colon CancerStage IV Rectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Up to 1 year

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive fluorouracil IV as a continuous infusion for 28 days.

Drug: fluorouracil

Arm II

EXPERIMENTAL

Patients receive eniluracil/fluorouracil orally twice a day for 28 days.

Drug: fluorouracilDrug: eniluracil

Interventions

fluorouracilDRUG

Given IV or orally

Also known as: 5-fluorouracil, 5-Fluracil, 5-FU
Arm IArm II
eniluracilDRUG

Given orally

Also known as: 776C85, ADH300004, ethynyluracil, GW776, GW776C85
Arm II

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with measurable or nonmeasurable histologically confirmed adenocarcinoma of the colon and rectum are eligible provided patient has metastatic, recurrent or residual disease, and tumor is beyond hope of surgical eradication; all pre-study scans documenting disease must be done =\< 4 weeks prior to randomization
  • Measurable tumor is defined as a known mass that can be clearly measured in two dimensions by physical examination, CT scan, radionuclide liver scan, or on chest x-ray by a ruler or calipers; the largest diameter of the lesion must measure \>= 2 cm by at least one method of evaluation
  • Patients must have had no prior therapy for advanced disease
  • Patients may have had prior adjuvant treatment with 5-FU provided that the last dose was received \> 12 months prior to entering the study; no prior chemotherapy other than adjuvant 5-FU is allowed
  • Patients with prior radiotherapy are acceptable, but patients should have measurable or nonmeasurable disease outside the radiation port and/or progressive disease within the previously radiated volume; in addition, it must be at least 2 weeks since administration of radiation therapy and all signs of toxicity must have abated
  • Bilirubin =\< 1.5 x upper limit of normal (ULN)
  • SGOT =\< 3 x ULN
  • Because Eniluracil changes the metabolism of 5-FU such that it is excreted primarily by the kidneys, an estimated creatinine clearance calculated using the Cockcroft and Gault formula must be obtained in patients with a serum creatinine \> institutional normal limits; the estimated creatinine clearance must be \>= 50 ml/min prior to starting treatment with Eniluracil/5-FU; if not, a measured creatinine clearance must be done (using a 24 hour urine collection); the measured creatinine clearance must be \> 50 ml/min for the patient to be eligible
  • Absolute neutrophil count \>= 2000 mm³
  • Platelet count \>= 100,000 mm³
  • ECOG performance status 0-2
  • No evidence of significant active infection (e.g., pneumonia, peritonitis, wound abscess, etc.) at time of study entry
  • No evidence of serious intercurrent illness such as uncontrolled diabetes mellitus, hypothyroidism, malabsorption syndrome or heart failure
  • No prior neoplastic diseases (within 5 years) aside from the current malignancy or curatively resected melanoma, skin cancer or cervical carcinoma in situ
  • No treatment with folinic acid, interferon, flucytosine or topical 5-FU within the previous 14 days
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Cooperative Oncology Group

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Colonic NeoplasmsRectal Neoplasms

Interventions

Fluorouracileniluracil

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • John Hines

    Eastern Cooperative Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

July 16, 2004

Study Start

April 1, 1999

Primary Completion

July 1, 2007

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

US(1)