COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01468623
Recruitment Status : Terminated (Study terminated due to slow enrollment.)
First Posted : November 9, 2011
Last Update Posted : January 31, 2013
Information provided by (Responsible Party):
Myriad Genetic Laboratories, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer, Metastatic Other: Pharmacokinetic 5-FU dose adjustment using OnDose® assay Other: Standard of care Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2011
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

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 Name: 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).

Primary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: 30 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01468623

Show Show 58 study locations
Sponsors and Collaborators
Myriad Genetic Laboratories, Inc.
Layout table for investigator information
Study Director: Abebe Haregewoin, MD, PhD Myriad Genetic Laboratories, Inc.

Layout table for additonal information
Responsible Party: Myriad Genetic Laboratories, Inc. Identifier: NCT01468623    
Other Study ID Numbers: PROFUSE-2011
First Posted: November 9, 2011    Key Record Dates
Last Update Posted: January 31, 2013
Last Verified: January 2013
Keywords provided by Myriad Genetic Laboratories, Inc.:
Colorectal cancer, metastatic
First line
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases