2 Versus 6 Hour Oxaliplatin Infusions in Patients With Gastrointestinal Cancers
ConditionMalignant Digestive System Neoplasm
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University
About this trial
This phase II trial studies how well giving oxaliplatin over 6 hours works in treating nerve damage in patients with gastrointestinal cancers. Oxaliplatin can cause side effects such as nerve damage that may delay or reduce the dose of oxaliplatin. Giving oxaliplatin over a longer period of time (6 hours) may prevent or delay the development of nerve damage, which may keep patients on standard doses of chemotherapy longer, without having to delay treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Confirmed diagnosis of a gastrointestinal cancer
Plan for 4 or more cycles of FOLFOX6 (fluorouracil [with leucovorin] and oxaliplatin) containing chemotherapy
Histologically confirmed, measurable or evaluable disease. Patients with advanced or metastatic disease should have at least one measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Patients in the adjuvant treatment setting planned to have > 4 cycles of FOLFOX-containing chemotherapy are eligible and will be followed per standard of care
Disqualifiers
Any preexisting grade 2 or higher peripheral neuropathy
Patients currently receiving anticancer therapies or who have received any focal or systemic anticancer therapy within 14days of the start of FOLFOX6
Known intolerance or hypersensitivity to any agent in FOLFOX6 or concurrent agents
Unstable angina pectoris, symptomatic heart failure; (New York Heart Association class III or IV), myocardial infarction ≤ 6 months prior, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease
Trial design
Design model
Parallel
Treatments tested in this trial
Fluorouracil
DrugGiven IV
Leucovorin
DrugGiven IV
Oxaliplatin
DrugGiven IV
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: 2-hour infusion groupActive comparator 3 interventions
Group B: 6-hour infusion groupExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Effect of 2 versus 6-hour oxaliplatin infusion time on neuropathy as measured by patient reported outcome (PRO) scores on the European Organization for Research and Treatment of Cancer (EORTC) chemotherapy-induced peripheral neuropathy (CIPN-20) scale
The EORTC-CIPN-20 sub-scales will be computed according to the standard scoring algorithm and then transformed to a 0 to 100 scale, where high scores mean less symptom burden. The primary outcome measure of difference in sensory scores of the two groups between baseline and the initiation of cycle 4 will be the driver of the analysis.
Time frame
Baseline up to 60 days (course 4)Secondary outcomes
1
Maximum concentrations achieved (Cmax)
The study will focus on maximum concentrations achieved (Cmax) with each infusion time. Data will be analyzed using non-compartmental methods via Phoenix WinNonlin analytical software, version 8.0 or higher.
Time frame
At baseline and at 1, 2, 4, 6, 48, and 192 hours after initiation of oxaliplatin2
Changes in tumor size
The study will assess changes in tumor size per standard of care assessments at screening and every 2 months.
Time frame
Up to 18 months after completion or discontinuation of chemotherapy3
Duration of therapy
Duration of therapy will be recorded.
Time frame
Up to 18 months after completion or discontinuation of chemotherapy4
Dose density
Dose density will be recorded.
Time frame
Up to 18 months after completion or discontinuation of chemotherapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Emory University
Lead sponsor
Hematology/Oncology Pharmacy Association
Collaborator
University of Pittsburgh
Collaborator
Source ClinicalTrials.gov