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

July 18, 2023 updated by: Myriad Genetic Laboratories, Inc.

A Prospective, Randomized, Open-label Trial Comparing OnDose® AUC Optimized 5-FU Based Administration Versus Standard Body Surface Area (BSA) Dosing in Metastatic Colorectal Cancer Patients (mCRC) Treated With mFOLFOX6

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • California
      • Corona, California, United States
      • Fountain Valley, California, United States
      • La Jolla, California, United States
      • Modesto, California, United States
      • Rancho Cucamonga, California, United States
      • Riverside, California, United States
      • Santa Rosa, California, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Merritt Island, Florida, United States
      • Ocala, Florida, United States
      • Titusville, Florida, United States
      • Viera, Florida, United States
    • Georgia
      • Albany, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
      • Crystal Lake, Illinois, United States
      • Galesburg, Illinois, United States
      • Grayslake, Illinois, United States
      • Highland Park, Illinois, United States
      • Lake Forest, Illinois, United States
      • Libertyville, Illinois, United States
      • Niles, Illinois, United States
      • Skokie, Illinois, United States
    • Indiana
      • Munster, Indiana, United States
    • Kentucky
      • Louisville, Kentucky, United States
    • Louisiana
      • Baton Rouge, Louisiana, United States
      • Metairie, Louisiana, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Detroit, Michigan, United States
      • Farmington Hills, Michigan, United States
    • Montana
      • Great Falls, Montana, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Jersey
      • Hackensack, New Jersey, United States
    • New York
      • Johnson City, New York, United States
    • North Carolina
      • Greensboro, North Carolina, United States
    • North Dakota
      • Fargo, North Dakota, United States
      • Minot, North Dakota, United States
    • Ohio
      • Canton, Ohio, United States
      • Columbus, Ohio, United States
    • Oregon
      • Bend, Oregon, United States
    • Pennsylvania
      • Drexel Hill, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
    • Tennessee
      • Crossville, Tennessee, United States
      • Huntsville, Tennessee, United States
    • Texas
      • Bedford, Texas, United States
      • Garland, Texas, United States
      • Grapevine, Texas, United States
      • Kerrville, Texas, United States
      • McAllen, Texas, United States
      • San Antonio, Texas, United States
      • Tyler, Texas, United States
      • Waco, Texas, United States
    • Utah
      • Ogden, Utah, United States
      • Salt Lake City, Utah, United States
    • Virginia
      • Fairfax, Virginia, United States
      • Newport News, Virginia, United States
    • Washington
      • Edmonds, Washington, United States
      • Seattle, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Selection Criteria:

  • Patients with histologically confirmed metastatic colorectal cancer
  • No prior chemotherapy for the treatment of metastatic colorectal cancer
  • At least one measurable lesion by CT or MRI of ≥ 20 mm (if conventional CT scan) or ≥ 10 mm (if spiral CT scan)
  • ECOG Performance Status (ECOG-PS) status ≤ 2
  • At least 18 years of age
  • Life expectancy > 6 months
  • Must be able and willing to give written informed consent
  • Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device), and must have a negative serum or urine pregnancy test within 1 week prior to beginning treatment on this trial. Nursing patients are excluded. Sexually active men must also use acceptable contraceptive methods (abstinence, condom).
  • ANC count greater than or equal to 1,500/ mm³
  • Platelets greater than or equal to 100,000/ mm³
  • Serum creatinine less than or equal to 2x upper limit of normal (normal range (male): 97-137 mL/min; (female): 88-128 mL/min)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 3x the upper limit of normal (≤ 5.0 x ULN is acceptable if liver has tumor involvement) (ALT normal range: < 41 iu/L (male), < 31 iu/L (female); AST normal range: < 37 iu/L (male), < 31 iu/L (female)).
  • Prothrombin Time (PT), activated partial thromboplastin time (aPTT) and INR ≤ 1.5 x ULN (INR normal range: 0.8-1.2) or in the therapeutic range if on anticoagulation.
  • Hemoglobin greater than or equal to 9 gm/dl (may be corrected by transfusion prior to 5-FU treatment with investigator approval).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OnDose®
Patients will receive FOLFOX6 with or without bevacizumab (Avastin). Patients' 5-FU dose will be optimized by measuring the Area Under the Curve (AUC) of 5-FU by the commercially available OnDose® assay and their dose for subsequent cycles adjusted following a pre-established dose adjustment algorithm.
Other: Pharmacokinetic 5-FU dose adjustment using OnDose® assay
OnDose is a commercially available assay to measure concentration of 5-FU exposure.
Other Names:
  • OnDose®
Active Comparator: Body Surface Area (BSA)
Patients will receive FOLFOX6 with or without bevacizumab (Avastin). Patients will receive 5-FU based on traditional BSA calculation and their dose adjusted based on standard clinical practice. OnDose® AUC measurements will be performed for this arm but will not be used for dose adjustment.
Other: Standard of care
Patients' dose of 5-FU will be based on Body Surface Area (BSA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate (ORR)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (PFS)
Time Frame: 30 months
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Myriad Genetic Laboratories, Inc.

Investigators

  • Study Director: Abebe Haregewoin, MD, PhD, Myriad Genetic Laboratories, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

November 1, 2011

First Submitted That Met QC Criteria

November 7, 2011

First Posted (Estimated)

November 9, 2011

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROFUSE-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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