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

Information source: Myriad Genetic Laboratories, Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colorectal Cancer, Metastatic

Intervention: Pharmacokinetic 5-FU dose adjustment using OnDose® assay (Other); Standard of care (Other)

Phase: Phase 4

Status: Terminated

Sponsored by: Myriad Genetic Laboratories, Inc.

Official(s) and/or principal investigator(s):
Abebe Haregewoin, MD, PhD, Study Director, Affiliation: Myriad Genetic Laboratories, Inc.


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Overall response rate (ORR)

Secondary outcome: Progression-free survival (PFS)


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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).

Locations and Contacts

Birmingham, Alabama, United States

Corona, California, United States

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Additional Information

Starting date: September 2011
Last updated: January 29, 2013

Page last updated: August 20, 2015

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