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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Chemotherapy dose-escalation algorithm based on the FOLFOX and FOLFOXIRI regimens
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
RECRUITINGProportion of patients that receive dose intensified infusional 5-FU in Cycle 6 of the FOX regimen
The proportion of patients who receive dose-intensified infusional 5-FU (dosed at greater than or equal to 2,800 mg/m2) in Cycle 6 of the FOX regimen.
Time frame: Through day 1 of Cycle 6 of FOX regimen (cycle length is 14 days)
Response rate to chemotherapy
Response rate (stratified by colorectal cancer vs. gastroesophageal cancer) as defined using RECIST 1.1 imaging criteria
Time frame: Through 6 months from Cycle 1 Day 1 of FOX regimen
Progression-free survival
Progression-free survival (PFS, stratified by colorectal cancer vs. gastroesophageal cancer, determined by retrospective review of medical records)
Time frame: Through 12 months from Cycle 1 Day 1 of FOX regimen
Dose intensity of 5-FU and oxaliplatin
Dose intensity of 5-FU and oxaliplatin over Cycles 1-6. Dose intensity will be calculated separately for each component of the FOLFOX regimen (5-FU infusion and oxaliplatin).
Time frame: Through day 1 of Cycle 6 of FOX regimen (cycle length is 14 days)
Mean plasma uracil concentration
Difference in mean plasma uracil concentration between patients who did and did not achieve sustained 5-FU dose escalation to ≥ 2,800 mg/m2 (primary endpoint)
Time frame: Single treatment visit 0-30 days before Day 1 of Cycle 1 of FOX regimen, (cycle length is 14 days)
5-FU drug exposure
5-FU drug exposure, measured as the area under the drug concentration curve (AUC). AUC will be calculated by multiplying the measured 5-FU concentration at steady state by the 5-FU infusion duration in hours.
Time frame: Single treatment visit on Day 3 of treament Cycle 5 or Cycle 6 of FOX regimen, (cycle length is 14 days)
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