Trial Summary
What is the purpose of this trial?The purpose of this research is to see if adjusting the dose of 5-fluorouracil based on its concentration in your blood will improve the treatment of your metastatic colon cancer.
Eligibility Criteria
This trial is for individuals with metastatic colorectal cancer. Participants should be suitable for chemotherapy and have not been treated with the study drugs before. Specific details about inclusion and exclusion criteria are not provided, but typically these would relate to overall health status, prior treatments, and other medical conditions.Inclusion Criteria
I can take care of myself but might not be able to do heavy physical work.
Life expectancy > 3 months
I haven't had treatment for cancer that has spread, but if I had 5-FU or FOLFOX, it was over 6 months ago.
+3 more
Exclusion Criteria
I have brain metastases but no ongoing symptoms without steroids.
It has been over 4 weeks since my last surgery or 2 weeks since my last radiation treatment.
I have a known DPD deficiency.
Participant Groups
The study is testing whether adjusting doses of the chemotherapy drug 5-fluorouracil (5-FU) based on blood concentration levels can improve outcomes in metastatic colon cancer treatment. Other chemo regimens like FOLFIRI, Modified FOLFOX6, and mFOLFOXIRI are also being tested biweekly.
1Treatment groups
Experimental Treatment
Group I: Chemotherapy with 5-FU/Leucovorin (LV) alone, with oxaliplatin or irinotecan or bothExperimental Treatment4 Interventions
Plasma specimens will be collected for the measurement of plasma 5-FU level from patients receiving 5-FU/LV alone, with oxaliplatin (mFOLFOX6) or irinotecan (FOLFIRI), or both (mFOLFOXIRI) chemotherapy. 5-FU doses will be modified based on the assay results.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Inova Health Care ServiceFalls Church, VA
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Who Is Running the Clinical Trial?
Inova Health Care ServicesLead Sponsor