NCT00081627

Brief Summary

The objectives of this trial are to determine if CoFactor in combination with 5-FU are effective in the treatment of metastatic colorectal cancer and to determine the side effects observed with the administration of CoFactor and 5-FU.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2004

Typical duration for phase_2

Geographic Reach
2 countries

9 active sites

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, 2004

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2004

Completed
6 months until next milestone

First Posted

Study publicly available on registry

October 14, 2004

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

November 27, 2007

Status Verified

November 1, 2007

First QC Date

April 15, 2004

Last Update Submit

November 26, 2007

Conditions

Colon CancerRectal Cancer

Interventions

CoFactor and 5FUDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients must have surgically incurable colon or rectal adenocarcinoma
  • Karnofsky Performance Status of 60% or greater
  • Patients may have symptomatic neuropathy
  • Patients must have a life expectancy of at least 4 months
  • Patients must be alimenting, receiving at least 1500Kcal/day nutrition, by any route
  • Patients must have bidimensional measurable disease for response assessment
  • Patients may have received adjuvant chemotherapy with fluoropyrimidine therapy
  • Patients must have recovered from the toxicities of prior therapy, at least 4 weeks since prior adjuvant chemotherapy and major surgery
  • Serum creatinine less than 2.4mg%, serum bilirubin less than 3.0mg%, WBC greater than 3,200/mm2, AGC greater than 1,500/mm3, platelet count greater than 90,000/mm3 and SGOT (AST) and SGPT (ALT) less than 3 times the upper limit of normal
  • Male and non-pregnant, non-lactating female patients must be \>18 years old.

You may not qualify if:

  • Concurrent infection
  • Failure of the patient or the patient's legal representative to sign the Informed consent
  • Inability to obtain Informed Consent because of psychiatric or complex medical problem
  • Patients with unstable oncologic emergency
  • Patients with unstable medical conditions such as angina, transient ischemic attacks, rising creatinine, accelerated hypertension, etc.
  • Cerebellar neurologic syndromes such as Parkinson's Disease, multiple sclerosis and amyotonia
  • Known intolerance to fluoropyrimidine therapy suggestive of dihydropyrimidine dehydrogenase deficiency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

UCSD Moores Cancer Center

La Jolla, California, 92037, United States

Location

Mercy General Hospital

Sacramento, California, 95819, United States

Location

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Killeen Cancer Center

Killeen, Texas, 76549, United States

Location

CHC Bezanijska Kosa

Belgrade, 11000, Serbia and Montenegro

Location

Clinical Center of Serbia

Belgrade, 11000, Serbia and Montenegro

Location

Institute for Oncology and Radiology Serbia

Belgrade, 11000, Serbia and Montenegro

Location

Institute of Oncology

Sremska Kamenica, 21204, Serbia and Montenegro

Location

MeSH Terms

Conditions

Colonic NeoplasmsRectal Neoplasms

Interventions

5,11-methenyltetrahydrohomofolateFluorouracil

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

  • Tony Reid, MD, PhD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 15, 2004

First Posted

October 14, 2004

Study Start

April 1, 2004

Study Completion

January 1, 2007

Last Updated

November 27, 2007

Record last verified: 2007-11

Locations

US(5)SE(4)