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

Colorectal Cancer, Metastatic Clinical Trial

— PROFUSE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01468623
• Other study ID #: PROFUSE-2011
• Status: Terminated
• Phase: Phase 4
• Start date: September 2011
• Est. completion date: August 2012

Study information

• Verified date: July 2023
• Source: Myriad Genetic Laboratories, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 in the Overall Response Rate (ORR) relative to BSA dosing response.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Colorectal Cancer, Metastatic
• Colorectal Neoplasms

Intervention

Other:
• Pharmacokinetic 5-FU dose adjustment using OnDose® assay
OnDose is a commercially available assay to measure concentration of 5-FU exposure.
• Standard of care
Patients' dose of 5-FU will be based on Body Surface Area (BSA).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Myriad Genetic Laboratories, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate (ORR)		6 months
Secondary	Progression-free survival (PFS)		30 months