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Trial Title:
Study of 5-fluorouracil (5-FU) in Patients With Metastatic Colorectal Cancer
NCT ID:
NCT06501989
Condition:
Metastatic Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Leucovorin
Folic Acid
Oxaliplatin
Fluorouracil
Irinotecan
Levoleucovorin
Conditions: Keywords:
5-fluorouracil (5-FU)
pharmacokinetic assay
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Each cycle of chemotherapy is 2 weeks long, so you will be receiving treatment on the
study for a total of 8 weeks. You will also need additional imaging (CT scans) after you
complete the first four cycles of chemotherapy, which brings your total time in the study
to about 3 months including treatment and follow-up.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Biweekly 5-FLUOROURACIL (5-FU)
Description:
5-FU 2400 mg/m². Infusion for 46 hours. Leucovorin 200 mg/m². Either a vascular
endothelial growth factor (VEGF) inhibitor or epidermal growth factor (EGFR) inhibitor or
may be added to the regimen at the discretion of the treating physician. Repeat every 2
weeks.
Arm group label:
Chemotherapy with 5-FU/Leucovorin (LV) alone, with oxaliplatin or irinotecan or both
Other name:
5-FU
Intervention type:
Drug
Intervention name:
Biweekly Modified FOLFOX6
Description:
Oxaliplatin 85 mg/m². 5-FU 400 mg/m² on day 1 as bolus (OPTIONAL). 5-FU 2400 mg/m²
Infusion for 46 hours. Leucovorin 200 mg/m2. Repeat every 2 weeks
Arm group label:
Chemotherapy with 5-FU/Leucovorin (LV) alone, with oxaliplatin or irinotecan or both
Other name:
fluorouracil, leucovorin, oxaliplatin combined
Intervention type:
Drug
Intervention name:
Biweekly FOLFIRI
Description:
Irinotecan 180 mg/m2. 5-FU 400 mg/m2 on day 1 as bolus (OPTIONAL). 5-FU 2400 mg/m2
Infusion for 46 hours. Leucovorin 200 mg/m2.
Repeat every 2 weeks.
Arm group label:
Chemotherapy with 5-FU/Leucovorin (LV) alone, with oxaliplatin or irinotecan or both
Other name:
irinotecan with fluorouracil (5FU) and folinic acid combined
Intervention type:
Drug
Intervention name:
mFOLFOXIRI
Description:
Irinotecan 165 mg/m2. Oxaliplatin 85 mg/m2. 5-FU 2400 mg/m2 Infusion for 46 hours. Repeat
every 2 weeks.
Arm group label:
Chemotherapy with 5-FU/Leucovorin (LV) alone, with oxaliplatin or irinotecan or both
Other name:
folinic acid, fluorouracil (5FU), oxaliplatin, irinotecan combined
Summary:
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.
Detailed description:
5-fluorouracil (5-FU) has been the most widely used agent in the treatment of early stage
and advanced colorectal cancer. Traditionally, 5-FU dosing is based on body surface area
(BSA). However, BSA-dosing has been associated with a wide range of pharmacokinetic (PK)
variability, resulting in marked differences in drug exposure and toxicities in an
individual. There is a significant association between the risk of 5-FU-related
toxicities and the extent of 5- FU systemic exposure, which can be measured using a
well-established pharmacokinetic (PK) assay.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Males or females at least 18 years of age.
- Histologically confirmed metastatic colorectal cancer eligible for treatment with
5-FU.
- No prior therapy for metastatic disease. If adjuvant 5-FU or FOLFOX was
administered, the last dose must have been at least 6 months prior to the diagnosis
of metastatic disease.
- Adequate organ function.
- Eastern Cooperative Oncology Group (ECOG) status less than or equal to 2.
- Life expectancy > 3 months.
Exclusion Criteria:
- Untreated brain metastasis. Treated brain metastases are allowed as long as symptoms
have resolved off of steroids.
- At least 4 weeks from any prior surgery or 2 weeks from radiation treatments.
- Known dihydropyrimidine dehydrogenase (DPD) deficiency.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Inova Health Care Service
Address:
City:
Falls Church
Zip:
22042
Country:
United States
Contact:
Last name:
Keary Jane't
Phone:
571-472-4724
Email:
keary.janet@inova.org
Contact backup:
Last name:
Elahe Mollapour
Email:
elahe.mollapour@inova.org
Investigator:
Last name:
Jasmine Huynh
Email:
Principal Investigator
Start date:
December 15, 2024
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Inova Health Care Services
Agency class:
Other
Source:
Inova Health Care Services
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06501989
