Status:
COMPLETED
Biomarker-Guided Fluorouracil in Treating Patients With Colorectal Cancer Receiving Combination Chemotherapy
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Diarrhea
Eligibility:
All Genders
Phase:
PHASE1
Brief 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 t...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT01164215
Start Date
February 1 2010
End Date
September 1 2013
Last Update
October 9 2015
Active Locations (5)
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1
Cancer Care of Western North Carolina
Asheville, North Carolina, United States, 28801
2
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro, North Carolina, United States, 27403-1198
3
Leo W. Jenkins Cancer Center at ECU Medical School
Greenville, North Carolina, United States, 27834
4
Rex Cancer Center at Rex Hospital
Raleigh, North Carolina, United States, 27607