Status:
TERMINATED
Study Comparing Optimized 5-FU Dosing and Standard Dosing in Metastatic Colorectal Cancer Patients Treated With mFOLFOX6
Lead Sponsor:
Myriad Genetic Laboratories, Inc.
Conditions:
Colorectal Cancer, Metastatic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT01468623
Start Date
September 1 2011
End Date
August 1 2012
Last Update
July 19 2023
Active Locations (58)
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1
Birmingham, Alabama, United States
2
Corona, California, United States
3
Fountain Valley, California, United States
4
La Jolla, California, United States