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

This study has been terminated.
(Study terminated due to slow enrollment.)
Sponsor:
Information provided by (Responsible Party):
Myriad Genetic Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT01468623
First received: November 1, 2011
Last updated: January 29, 2013
Last verified: January 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Myriad Genetic Laboratories, Inc.:

Primary Outcome Measures:
  • Overall response rate (ORR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: 30 months ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: September 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01468623

  Show 58 Study Locations
Sponsors and Collaborators
Myriad Genetic Laboratories, Inc.
Investigators
Study Director: Abebe Haregewoin, MD, PhD Myriad Genetic Laboratories, Inc.
  More Information

No publications provided

Responsible Party: Myriad Genetic Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT01468623     History of Changes
Other Study ID Numbers: PROFUSE-2011
Study First Received: November 1, 2011
Last Updated: January 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Myriad Genetic Laboratories, Inc.:
Colorectal cancer, metastatic
FOLFOX6
5-FU
First line
bevacizumab

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on October 01, 2014