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Colorectal Cancer, MetastaticPhase 4PROFUSENCT01468623

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

A Phase 4 study testing Pharmacokinetic 5-FU dose adjustment using OnDose® assay in people with Colorectal Cancer, Metastatic, run by Myriad Genetic Laboratories, Inc. at 58 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer, Metastatic
What is being tested?
Pharmacokinetic 5-FU dose adjustment using OnDose® assay
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
58 sitesUnited States
Study dates
Sep 2011to Aug 2012
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Trial locations and contacts

58 sites in 1 country.

58 sites in 1 country

United States58 sites

  • Study site

    Albany, Georgia

  • Study site

    Ann Arbor, Michigan

  • Study site

    Baton Rouge, Louisiana

  • Study site

    Bedford, Texas

  • Study site

    Bend, Oregon

  • Study site

    Birmingham, Alabama

  • Study site

    Canton, Ohio

  • Study site

    Chicago, Illinois

  • Study site

    Columbus, Ohio

  • Study site

    Corona, California

  • Study site

    Crossville, Tennessee

  • Study site

    Crystal Lake, Illinois

  • Study site

    Detroit, Michigan

  • Study site

    Drexel Hill, Pennsylvania

  • Study site

    Edmonds, Washington

  • Study site

    Fairfax, Virginia

  • Study site

    Fargo, North Dakota

  • Study site

    Farmington Hills, Michigan

  • Study site

    Fountain Valley, California

  • Study site

    Galesburg, Illinois

  • Study site

    Garland, Texas

  • Study site

    Grapevine, Texas

  • Study site

    Grayslake, Illinois

  • Study site

    Great Falls, Montana

  • Study site

    Greensboro, North Carolina

  • Study site

    Hackensack, New Jersey

  • Study site

    Highland Park, Illinois

  • Study site

    Huntsville, Tennessee

  • Study site

    Johnson City, New York

  • Study site

    Kerrville, Texas

  • Study site

    La Jolla, California

  • Study site

    Lake Forest, Illinois

  • Study site

    Las Vegas, Nevada

  • Study site

    Libertyville, Illinois

  • Study site

    Louisville, Kentucky

  • Study site

    McAllen, Texas

  • Study site

    Merritt Island, Florida

  • Study site

    Metairie, Louisiana

  • Study site

    Minot, North Dakota

  • Study site

    Modesto, California

  • Study site

    Munster, Indiana

  • Study site

    Newport News, Virginia

  • Study site

    Niles, Illinois

  • Study site

    Ocala, Florida

  • Study site

    Ogden, Utah

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Rancho Cucamonga, California

  • Study site

    Riverside, California

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    Santa Rosa, California

  • Study site

    Seattle, Washington

  • Study site

    Skokie, Illinois

  • Study site

    Titusville, Florida

  • Study site

    Tyler, Texas

  • Study site

    Viera, Florida

  • Study site

    Waco, Texas

  • Study site

    Washington D.C., District of Columbia

Other trials in United States

About this study

Official title: 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.

Being tested
Pharmacokinetic 5-FU dose adjustment using OnDose® assay, Standard of care
Keywords
Colorectal cancer, metastatic, FOLFOX6, 5-FU, First line, bevacizumab
Medical subject headings
Colorectal Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pharmacokinetic 5-FU dose adjustment using OnDose® assayOther

    Also called OnDose®

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

  • Standard of careOther

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

Study groups in NCT01468623
Study groupRoleWhat they receive
OnDose®ExperimentalPatients 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.
Receives: Other: Pharmacokinetic 5-FU dose adjustment using OnDose® assay
Body Surface Area (BSA)Active comparatorPatients 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.
Receives: Other: Standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate (ORR)

    Measured: 6 months

Secondary outcomes (1)

  1. Progression-free survival (PFS)

    Measured: 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionAug 2012
  4. Study completionAug 2012

Why it stopped: Study terminated due to slow enrollment.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01468623
Sponsor's protocol ID
PROFUSE-2011
Acronym
PROFUSE
Status last verified
Jul 2023
First submitted
1 Nov 2011
Last updated
19 Jul 2023
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pharmacokinetic 5-FU dose adjustment using OnDose® assay in people with Colorectal Cancer, Metastatic, run by Myriad Genetic Laboratories, Inc. at 58 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study terminated due to slow enrollment.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01468623.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.

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