A Phase 1 interventional study of fluorouracil and leucovorin in Colorectal Cancer, Diarrhea and Neutropenia, sponsored by UNC Lineberger Comprehensive Cancer Center. Completed at 5 sites in United States. Per ClinicalTrials.gov, last updated 2015-10-09.
Sponsored by UNC Lineberger Comprehensive Cancer Center · Phase 1, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, oxaliplatin, and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug, combination chemotherapy, may kill more tumor cells. Studying samples of blood in the laboratory from patients with cancer receiving fluorouracil in combination with oxaliplatin and leucovorin calcium may help doctors learn how fluorouracil works in the body and how patients will respond to treatment.
PURPOSE: This phase I trial is studying biomarker-guided fluorouracil in treating patients with colorectal cancer receiving combination chemotherapy.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients undergo plasma sample collection periodically during study for pharmacokinetic (PK)-guided fluorouracil dose determination for courses 2-4.
NOTE: *The continuous infusion fluorouracil dose adjustment is calculated based on the results of PK plasma concentrations and the corresponding AUC from the preceding course.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 76 is close to the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 414 studies on the registry; 96 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 25 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No concurrent warfarin (Coumadin®)
Patients will receive cycle 1 of standard dose mFOLFOX6, with the same dose of mFOLFOX6 continued in subsequent cycles, once patient achieves the target AUC. mFOLFOX 6 is a regimen comprised of Oxaliplatin + Leucovorin +5-Fluorouracil (FU)
Drug: fluorouracil · Drug: leucovorin · Drug: oxaliplatin
200-400 mg/m2 intravenously, 1 -5 minutes, once every 2 weeks 2400 mg/m2 intravenously over a period of 46 hours, once every 2 weeks
Also known as: 5FU
200-400 mg/m2, intravenously over a period of 2 hours, once every 2 weeks
Also known as: leucovorin calcium
85 mg/m2, intravenously for 2 hours, once every 2 weeks
Also known as: Eloxatin
Achievement of targeted AUC using pharmacokinetic (PK)-guided 5 fluorouracil as part of mFOLFOX6 therapy
Time frame: During first 4 cycles of drug therapy
Toxicity differences between PK-guided therapy versus non-PK-guided therapy
Time frame: 24 months
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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UNC Lineberger Comprehensive Cancer Center