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

Qualifiers

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

Treatments tested in this trial

Fluorouracil
Leucovorin
Oxaliplatin

Treatment groups

60 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Emory University

Lead sponsor

Hematology/Oncology Pharmacy Association

Collaborator

University of Pittsburgh

Collaborator

Source ClinicalTrials.gov