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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.

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.

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)

Eligibility

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

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).

Locations and Contacts

Birmingham, Alabama, United States

Corona, California, United States

Fountain Valley, California, United States

La Jolla, California, United States

Modesto, California, United States

Ranch Cucamonga, California, United States

Riverside, California, United States

Santa Rosa, California, United States

Washington, District of Columbia, United States

Merrit Island, Florida, United States

Ocala, Florida, United States

Titusville, Florida, United States

Viera, Florida, United States

Albany, Georgia, United States

Chicago, Illinois, United States

Crystal Lake, Illinois, United States

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Louisville, Kentucky, United States

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Metairie, Louisiana, United States

Ann Arbor, Michigan, United States

Detroit, Michigan, United States

Farmington Hill, Michigan, United States

Great Falls, Montana, United States

Las Vegas, Nevada, United States

Hackensack, New Jersey, United States

Johnson City, New York, United States

Greensboro, North Carolina, United States

Fargo, North Dakota, United States

Minot, North Dakota, United States

Canton, Ohio, United States

Columbus, Ohio, United States

Bend, Oregon, United States

Drexel Hill, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Crossville, Tennessee, United States

Huntsville, Tennessee, United States

Bedford, Texas, United States

Garland, Texas, United States

Grapevine, Texas, United States

Kerryville, Texas, United States

McAllen, Texas, United States

San Antonio, Texas, United States

Tyler, Texas, United States

Waco, Texas, United States

Ogden, Utah, United States

Salt Lake City, Utah, United States

Fairfax, Virginia, United States

Newport News, Virginia, United States

Edmonds, Washington, United States

Seattle, Washington, United States

Additional Information

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

Page last updated: August 20, 2015

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