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

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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01468623
Acronym
PROFUSE
Enrollment
51
Registered
2011-11-09
Start date
2011-09-30
Completion date
2012-08-31
Last updated
2023-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Metastatic

Keywords

Colorectal cancer, metastatic, FOLFOX6, 5-FU, First line, bevacizumab

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.

Interventions

OTHERPharmacokinetic 5-FU dose adjustment using OnDose® assay

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

OTHERStandard of care

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

Sponsors

Myriad Genetic Laboratories, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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).

Design outcomes

Primary

MeasureTime frame
Overall response rate (ORR)6 months

Secondary

MeasureTime frame
Progression-free survival (PFS)30 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026