This phase II trial studies the effect of a chemotherapy dose adjustment algorithm for preventing unplanned chemotherapy delays during FOLFOX chemotherapy in patients with gastrointestinal cancers (colon, rectal, esophageal, stomach, appendix, or small intestine). FOLFOX consists of the chemotherapy drugs leucovorin calcium, 5-fluorouracil and oxaliplatin. Reduced blood counts are a common side effect of the FOLFOX chemotherapy regimen. This can place patients at risk for infection or bleeding events, which often leads to unplanned delays in chemotherapy treatment. Doctors cannot predict which patients will experience reduced blood counts, therefore chemotherapy delays are usually unexpected. These delays cause patients to spend extra time and money traveling to an office visit at which the planned chemotherapy treatment cannot be given. This study is testing a new way to adjust the dosing of FOLFOX chemotherapy over time to lower the number of unexpected delays, while maintaining safe and effective chemotherapy dose levels.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04526886.
PRIMARY OBJECTIVE:
I. To evaluate the effectiveness of the investigator-developed chemotherapy dose adjustment algorithm for reducing unplanned delays in patients receiving FOLFOX-type chemotherapy.
SECONDARY OBJECTIVES:
I. To confirm the safety of the investigator-developed dose adjustment algorithm, by demonstrating that the study algorithm is associated with a low rate of cytopenia-related adverse events.
II. To evaluate the dose intensity of FOLFOX chemotherapy in patients managed according to the investigational dose adjustment algorithm, relative to the standard dose intensity (RDI).
III. To estimate out-of-pocket costs associated with chemotherapy treatment visits and unplanned chemotherapy delays.
OUTLINE:
Patients receive oxaliplatin intravenously (IV) over 85-120 minutes, 5-fluorouracil IV push and via infusion over 46 hours, and leucovorin calcium. Treatment repeats every 14 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. For each chemotherapy treatment in cycles 2-6, any chemotherapy delays or dose-reductions are guided by neutrophil and platelet counts, with dose reductions as indicated by the study dose adjustment algorithm.
Lead OrganizationDartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Principal InvestigatorGabriel Arne Brooks
