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COFU: A Multi-Center Phase II Clinical Trial to Evaluate the Safety and Efficacy of Weekly Treatment With CoFactor and 5-Fluorouracil in Patients With Metastatic Colorectal Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Colon Cancer, Rectal Cancer

Thank you

Trial Information

COFU: A Multi-Center Phase II Clinical Trial to Evaluate the Safety and Efficacy of Weekly Treatment With CoFactor and 5-Fluorouracil in Patients With Metastatic Colorectal Carcinoma


Inclusion Criteria:



- 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.

Exclusion Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Tony Reid, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Diego

Authority:

United States: Food and Drug Administration

Study ID:

02-CoFactor

NCT ID:

NCT00081627

Start Date:

April 2004

Completion Date:

January 2007

Related Keywords:

  • Colon Cancer
  • Rectal Cancer
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colorectal Neoplasms

Name

Location

Mercy General HospitalSacramento, California  95819
UCSD Moores Cancer CenterLa Jolla, California  93093
Spectrum HealthGrand Rapids, Michigan  49503
VA San Diego Healthcare SystemSan Diego, California  92161
Killeen Cancer CenterKilleen, Texas  76549