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Study Comparing Optimized 5-FU Dosing and Standard Dosing in Metastatic Colorectal Cancer Patients Treated With mFOLFOX6

NCT01468623 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2023-07-19

No results posted yet for this study

Summary

The purpose of this study is to compare OnDose® based pharmacokinetic administration of 5-FU versus standard Body Surface Area (BSA) based administration of 5-FU in patients with metastatic colorectal cancer treated with mFOLFOX6, with or without bevacizumab, to determine if the use of OnDose® achieves an improvement in the Overall Response Rate (ORR) relative to BSA dosing response.

Conditions

  • Colorectal Cancer, Metastatic

Interventions

OTHER

Pharmacokinetic 5-FU dose adjustment using OnDose® assay

OnDose is a commercially available assay to measure concentration of 5-FU exposure.

OTHER

Standard of care

Patients' dose of 5-FU will be based on Body Surface Area (BSA).

Sponsors & Collaborators

  • Myriad Genetic Laboratories, Inc.

    lead INDUSTRY

Principal Investigators

  • Abebe Haregewoin, MD, PhD · Myriad Genetic Laboratories, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01468623 on ClinicalTrials.gov