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Anti-metabolites
Individualized 5-FU Dosing for Gastrointestinal Cancer
N/A
Recruiting
Led By Gabriel A Brooks, M.D.
Research Sponsored by Dartmouth-Hitchcock Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up single treatment visit 0-30 days before day 1 of cycle 1 of fox regimen, (cycle length is 14 days)
Awards & highlights
Study Summary
This trial is testing an individualized chemo regimen to see if it is an effective and safe way to treat cancer.
Who is the study for?
This trial is for adults with advanced gastrointestinal cancers, including colorectal and non-colorectal types. Participants must be in good physical condition (ECOG 0-1) and have not received certain chemotherapies recently. They can't join if they are pregnant, breastfeeding, have specific blood or liver issues, drug dependencies, or other serious health conditions.Check my eligibility
What is being tested?
The study tests a personalized dose increase of the chemotherapy drug 5-FU for patients who handle an initial dose well. It's combined with standard doses of oxaliplatin to see if this method is feasible and effective without causing severe side effects.See study design
What are the potential side effects?
Potential side effects include those typical of chemotherapy such as nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems, nerve damage from oxaliplatin, and possibly diarrhea due to higher doses of 5-FU.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ single treatment visit 0-30 days before day 1 of cycle 1 of fox regimen, (cycle length is 14 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~single treatment visit 0-30 days before day 1 of cycle 1 of fox regimen, (cycle length is 14 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients that receive dose intensified infusional 5-FU in Cycle 6 of the FOX regimen
Secondary outcome measures
5-FU drug exposure
Dose intensity of 5-FU and oxaliplatin
Mean plasma uracil concentration
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Study ArmExperimental Treatment1 Intervention
All patients in this single-study arm will be exposed to the FOX regimen, an adaptively dose-escalated chemotherapy regimen. The FOX regimen is comprised of oxaliplatin 85 mg/m2 IV on Day 1; leucovorin calcium 350 mg IV on Day 1; and infusional 5-FU IV over 46 hours (Days 1 and 2) - starting at a dose of 2,400 mg/m2 and adaptively adjusted toward a maximum dose of 3,200 mg/m2 over Cycles 2-4 using a clinical algorithm.
Find a Location
Who is running the clinical trial?
Dartmouth-Hitchcock Medical CenterLead Sponsor
524 Previous Clinical Trials
2,540,753 Total Patients Enrolled
Gabriel A Brooks, M.D.Principal InvestigatorDartmouth-Hitchcock Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.I have previously received oxaliplatin or fluoropyrimidine chemotherapy.I haven't had chemotherapy in the last 6 months, except to make radiation work better.My cancer is known to have a mismatch repair deficiency.I do not have another cancer that needs treatment during the study.My cancer is advanced and cannot be removed by surgery.I am unable to understand or sign the consent form.I have been diagnosed with DPD deficiency.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Study Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still availability for participants in this research endeavor?
"Affirmative. The information on clinicaltrials.gov indicates that recruitment for this trial is currently underway, having first been posted in July 14th 2023 and most recently updated also in the same month of the same year. A total of 36 participants are required to be recruited from one site."
Answered by AI
What is the total number of participants involved in this clinical trial?
"Affirmative. Evidenced on clinicaltrials.gov, this scientific research is actively seeking participants with the trial first posted on July 14th 2023 and recently edited in same month. 36 distinct patients must be enrolled from one medical site."
Answered by AI
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