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

NCT01468623 | Terminated Phase 4 DMC

• 1 other identifier: PROFUSE-2011
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 58

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.

Conditions

Colorectal Cancer, Metastatic

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  6 months

Secondary Outcomes (1)

• Progression-free survival (PFS)

  30 months

Study Arms (2)

OnDose®

EXPERIMENTAL

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

Body Surface Area (BSA)

ACTIVE COMPARATOR

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

Interventions

Pharmacokinetic 5-FU dose adjustment using OnDose® assay OTHER

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

Also known as: OnDose®

OnDose®

Standard of care OTHER

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

Body Surface Area (BSA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Myriad Genetic Laboratories, Inc.: lead

Study Sites (58)

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Birmingham, Alabama, United States

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Corona, California, United States

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Fountain Valley, California, United States

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La Jolla, California, United States

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Modesto, California, United States

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Rancho Cucamonga, California, United States

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Riverside, California, United States

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Santa Rosa, California, United States

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Washington D.C., District of Columbia, United States

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Merritt Island, Florida, United States

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Ocala, Florida, United States

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Titusville, Florida, United States

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Viera, Florida, United States

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Albany, Georgia, United States

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Chicago, Illinois, United States

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Crystal Lake, Illinois, United States

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Galesburg, Illinois, United States

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Grayslake, Illinois, United States

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Highland Park, Illinois, United States

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Lake Forest, Illinois, United States

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Libertyville, Illinois, United States

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Niles, Illinois, United States

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Skokie, Illinois, United States

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Munster, Indiana, United States

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Louisville, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Metairie, Louisiana, United States

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Ann Arbor, Michigan, United States

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Detroit, Michigan, United States

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Farmington Hills, Michigan, United States

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Great Falls, Montana, United States

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Las Vegas, Nevada, United States

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Hackensack, New Jersey, United States

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Johnson City, New York, United States

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Greensboro, North Carolina, United States

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Fargo, North Dakota, United States

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Minot, North Dakota, United States

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Canton, Ohio, United States

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Columbus, Ohio, United States

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Bend, Oregon, United States

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Drexel Hill, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Crossville, Tennessee, United States

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Huntsville, Tennessee, United States

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Bedford, Texas, United States

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Garland, Texas, United States

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Grapevine, Texas, United States

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Kerrville, Texas, United States

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McAllen, Texas, United States

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San Antonio, Texas, United States

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Tyler, Texas, United States

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Waco, Texas, United States

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Ogden, Utah, United States

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Salt Lake City, Utah, United States

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Fairfax, Virginia, United States

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Newport News, Virginia, United States

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Edmonds, Washington, United States

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Seattle, Washington, United States

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MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Abebe Haregewoin, MD, PhD

  Myriad Genetic Laboratories, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2011
• First Posted: November 9, 2011
• Study Start: September 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: July 19, 2023

Record last verified: 2023-07

Locations

US (58)