Clinical trial NCT01468623: Study Comparing Optimized 5-FU Dosing and Standard Dosing in Metastatic Colorectal Cancer Patients Treated With mFOLFOX6
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Colorectal Cancer, Metastatic
Keywords: Colorectal cancer, metastatic
FOLFOX6
5-FU
First line
bevacizumab
Lead sponsor: Myriad Genetic Laboratories, Inc.
Sponsor class: INDUSTRY
First posted: 2011-11-09
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: 6 months
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 30 months
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Corona
country: United States
state: California
city: Fountain Valley
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Modesto
country: United States
state: California
city: Rancho Cucamonga
country: United States
state: California
city: Riverside
country: United States
state: California
city: Santa Rosa
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Merritt Island
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Titusville
country: United States
state: Florida
city: Viera
country: United States
state: Florida
city: Albany
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Crystal Lake
country: United States
state: Illinois
city: Galesburg
country: United States
state: Illinois
city: Grayslake
country: United States
state: Illinois
city: Highland Park
country: United States
state: Illinois
city: Lake Forest
country: United States
state: Illinois
city: Libertyville
country: United States
state: Illinois
city: Niles
country: United States
state: Illinois
city: Skokie
country: United States
state: Illinois
city: Munster
country: United States
state: Indiana
city: Louisville
country: United States
state: Kentucky
city: Baton Rouge
country: United States
state: Louisiana
city: Metairie
country: United States
state: Louisiana
city: Ann Arbor
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Farmington Hills
country: United States
state: Michigan
city: Great Falls
country: United States
state: Montana
city: Las Vegas
country: United States
state: Nevada
city: Hackensack
country: United States
state: New Jersey
city: Johnson City
country: United States
state: New York
city: Greensboro
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Minot
country: United States
state: North Dakota
city: Canton
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Bend
country: United States
state: Oregon
city: Drexel Hill
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Crossville
country: United States
state: Tennessee
city: Huntsville
country: United States
state: Tennessee
city: Bedford
country: United States
state: Texas
city: Garland
country: United States
state: Texas
city: Grapevine
country: United States
state: Texas
city: Kerrville
country: United States
state: Texas
city: McAllen
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Waco
country: United States
state: Texas
city: Ogden
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Fairfax
country: United States
state: Virginia
city: Newport News
country: United States
state: Virginia
city: Edmonds
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Myriad Genetic Laboratories, Inc.
name: Abebe Haregewoin, MD, PhD
role: STUDY_DIRECTOR
References: