36 Participants Needed

Individualized 5-FU Dosing for Gastrointestinal Cancer

(FOXRegimen Trial)

GC
CO
RN
Overseen ByResearch Nurse
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Dartmouth-Hitchcock Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a single-arm clinical trial to evaluate the feasibility of a chemotherapy regimen using adaptive, individualized dose escalation of 5-FU chemotherapy for patients who have good tolerance of the initial dose. Study participants will also receive oxaliplatin chemotherapy together with 5-FU, at standard doses. The goal of the study is to examine the feasibility and effectiveness of this approach, using individualized dose escalation of 5-FU in patients who do not have serious side effects at lower doses.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have received certain types of chemotherapy in the past six months, you may not be eligible to participate.

Is 5-FU generally safe for humans?

5-FU (Fluorouracil) has been used in various cancer treatments and is generally considered safe when used correctly, though it can cause side effects like neutropenia (low white blood cell count) and vomiting. Studies have shown that high doses can be used safely with precautions, such as combining with other drugs to reduce toxicity.12345

What makes the drug 5-FU unique for gastrointestinal cancer treatment?

The drug 5-FU is unique for gastrointestinal cancer treatment because it involves individualized dosing, which means the amount given is tailored to each patient to improve effectiveness and reduce side effects. This approach considers individual differences in how patients respond to the drug, potentially leading to better outcomes.35678

What data supports the effectiveness of the drug 5-FU for gastrointestinal cancer?

Research shows that adjusting the dose of 5-FU based on individual patient needs can improve outcomes in colorectal cancer, which is a type of gastrointestinal cancer. This suggests that personalized dosing of 5-FU might also be effective for other gastrointestinal cancers.59101112

Who Is on the Research Team?

Gabriel A. Brooks, MD | Find a Provider ...

Gabriel A. Brooks

Principal Investigator

Dartmouth-Hitchcock Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am fully active or can carry out light work.
My cancer is advanced and cannot be removed by surgery.
Clinically appropriate staging imaging of the chest, abdomen, and pelvis performed within 30 days prior to registration

Exclusion Criteria

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.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the FOX regimen, which includes oxaliplatin and 5-FU with adaptive dose escalation over Cycles 1-6

12 weeks
6 cycles, each 14 days long

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Long-term follow-up

Progression-free survival is assessed up to 12 months from Cycle 1 Day 1

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • 5-FU
  • FOX dose-escalation algorithm
  • Oxaliplatin
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Study ArmExperimental Treatment1 Intervention

5-FU is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as Fluorouracil for:
🇪🇺
Approved in European Union as Fluorouracil for:
🇨🇦
Approved in Canada as Fluorouracil for:
🇯🇵
Approved in Japan as Fluorouracil for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials
548
Recruited
2,545,000+

Published Research Related to This Trial

The maximum-tolerated dose (MTD) of 5-fluorouracil (5-FU) in combination with fixed doses of docetaxel and cisplatin for treating advanced gastric cancer was determined to be 1,750 mg/m², with a favorable safety profile as less than 10% of patients experienced severe toxicities.
Among 19 patients evaluated for treatment response, the overall response rate was 26%, increasing to 39% in those who had not received prior chemotherapy, suggesting that this regimen is effective and warrants further investigation in larger trials.
Phase I dose-escalating study of 24-h continuous infusion of 5-fluorouracil in combination with weekly docetaxel and cisplatin in patients with advanced gastric cancer.Wang, B., Zhang, W., Hong, X., et al.[2018]
In a study of 115 colorectal cancer patients undergoing 5-FU-based chemotherapy, those who experienced disease recurrence had significantly lower plasma concentrations of 5-FU, indicating that pharmacokinetics may play a crucial role in treatment outcomes.
Completing all 6 cycles of chemotherapy without dose modifications was identified as the only independent risk factor for improved disease-free survival, highlighting the importance of adherence to treatment protocols.
5-fluorouracil pharmacokinetics predicts disease-free survival in patients administered adjuvant chemotherapy for colorectal cancer.Di Paolo, A., Lencioni, M., Amatori, F., et al.[2022]
In a study of 570 patients with stage III colorectal cancer, three different administration types of 5-fluorouracil (5-FU) in FOLFOX treatment showed similar disease-free survival (DFS) and overall survival (OS) rates, indicating comparable efficacy.
While all treatment regimens were manageable in terms of toxicity, the modified FOLFOX-6 group experienced more grade 1-2 adverse events like thrombocytopenia and neuropathy, suggesting that while efficacy is similar, side effects may vary among the different regimens.
The comparison of FOLFOX regimens with different doses of 5-FU for the adjuvant treatment of colorectal cancer: a multicenter study.Akdeniz, N., Kaplan, MA., Uncu, D., et al.[2021]

Citations

Phase I dose-escalating study of 24-h continuous infusion of 5-fluorouracil in combination with weekly docetaxel and cisplatin in patients with advanced gastric cancer. [2018]
5-fluorouracil pharmacokinetics predicts disease-free survival in patients administered adjuvant chemotherapy for colorectal cancer. [2022]
The comparison of FOLFOX regimens with different doses of 5-FU for the adjuvant treatment of colorectal cancer: a multicenter study. [2021]
[Individual Dose Adjustment of 5-Fluorouracil Based on Pharmacokinetic Monitoring May Improve the Outcome of FOLFOX for Metastatic Colorectal Cancer]. [2016]
Phase II study of trimetrexate, fluorouracil, and leucovorin for advanced colorectal cancer. [2017]
Bimonthly 24 h infusion of high-dose 5-fluorouracil vs EAP regimen in patients with advanced gastric cancer. A randomized phase II study. [2021]
Lack of pharmacokinetic interaction between 5-fluorouracil and oxaliplatin. [2018]
[5-fluorouracil in high doses. Principles and toxicity]. [2013]
Randomised trial comparing three different schedules of infusional 5FU and raltitrexed alone as first-line therapy in metastatic colorectal cancer. Final results of the Fédération Francophone de Cancérologie Digestive (FFCD) 9601 trial. [2014]
Study to predict optimal duration of chemotherapy with fluoropyrimidine by multi-point collagen gel droplet embedded drug sensitivity test. [2013]
A dose-escalating study of oral eniluracil/5-fluorouracil plus oxaliplatin in patients with advanced gastrointestinal malignancies. [2020]
12.United Statespubmed.ncbi.nlm.nih.gov
Influence of inflammatory bowel disease on the ability of patients to tolerate systemic fluorouracil-based chemotherapy. [2017]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security