Colon Cancer Clinical Trial

Biomarker-Guided Fluorouracil in Treating Patients With Colorectal Cancer Receiving Combination Chemotherapy

Summary

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.

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Full Description

OBJECTIVES:

Primary

To determine whether 4 courses of pharmacokinetic (PK)-guided 5-fluorouracil chemotherapy improves the ability to achieve a targeted area under the curve (20 to 25 mg*hr/L) in patients with colorectal cancer receiving mFOLFOX6 chemotherapy as compared to historical non-PK-guided therapy in patients treated with a similar FOLFOX regimen.

Secondary

To determine and compare the incidence of neutropenia and diarrhea in patients treated with these regimens.

OUTLINE: This is a multicenter study.

Standard mFOLFOX6 (course 1): Patients receive fluorouracil IV bolus over 1-5 minutes followed by fluorouracil IV continuously over 46 hours, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1.

Patients undergo plasma sample collection periodically during study for pharmacokinetic (PK)-guided fluorouracil dose determination for courses 2-4.

PK-guided mFOLFOX6 (courses 2-4): Patients receive fluorouracil bolus, oxaliplatin, and leucovorin calcium as in course 1. Patients also receive fluorouracil* IV continuously as determined by the PK-guided analysis.

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.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed colorectal cancer
Patients scheduled to receive mFOLFOX6 (in the adjuvant setting or for metastatic disease) as part of their chemotherapy regimen

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Life expectancy > 6 months
ANC ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Serum creatinine ≤ 1.5 mg/dL
Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN in the presence of liver metastases)
Fertile patients must use effective contraception
Negative pregnancy test
Not pregnant or nursing
No serious concomitant systemic disorders, including active infection that, in the opinion of the investigator, would compromise the patient's safety or ability to complete the study
No altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies
Must be able to follow protocol requirements and give informed consent

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Concurrent bevacizumab allowed

No concurrent warfarin (Coumadin®)

Concurrent enoxaparin (Lovenox®) allowed
No concurrent theophylline or aminophylline
No chocolate beginning 12 hours before day 1 of each course and through the end of that course's fluorouracil continuous IV

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

76

Study ID:

NCT01164215

Recruitment Status:

Completed

Sponsor:

UNC Lineberger Comprehensive Cancer Center

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There are 5 Locations for this study

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Cancer Care of Western North Carolina
Asheville North Carolina, 28801, United States
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro North Carolina, 27403, United States
Leo W. Jenkins Cancer Center at ECU Medical School
Greenville North Carolina, 27834, United States
Rex Cancer Center at Rex Hospital
Raleigh North Carolina, 27607, United States
Marion L. Shepard Cancer Center
Washington North Carolina, 27889, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

76

Study ID:

NCT01164215

Recruitment Status:

Completed

Sponsor:


UNC Lineberger Comprehensive Cancer Center

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