Actively Recruiting
Phase II Evaluation of 2 Versus 6 Hour Oxaliplatin Infusions on Neuropathy and Pharmacokinetics in Gastrointestinal Cancer Patients
Led by Emory University · Updated on 2025-11-06
60
Participants Needed
3
Research Sites
6 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
H
Hematology/Oncology Pharmacy Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how the duration of oxaliplatin infusion affects nerve damage in patients with gastrointestinal cancers. This phase II trial compares giving oxaliplatin over 2 hours versus 6 hours to see if a longer infusion can reduce or delay nerve damage, which may allow patients to stay on standard chemotherapy doses longer without delays. The European Organization for Research and Treatment of Cancers patient-reported neuropathy scale CIPN-20 is used to measure nerve damage severity. Participants are randomly assigned to one of two groups one receives oxaliplatin and leucovorin intravenously over 2 hours along with fluorouracil given in two doses a quick low dose and a continuous higher dose on day 1 the other receives oxaliplatin over 6 hours with leucovorin and fluorouracil as in the first group. Treatments are repeated every 14 days unless disease progresses or side effects are unacceptable. After treatment, patients are followed up at 1, 3, 6, 12, and 18 months. Throughout the study, patients undergo evaluations including measurements of nerve damage using the CIPN-20 scale, pharmacokinetic tests to assess drug concentration and clearance, tumor size monitoring, and records of therapy duration, dose adjustments, and treatment delays. These assessments help researchers understand how infusion time affects nerve damage severity and overall treatment delivery. The total participation duration includes the treatment period and up to 18 months of follow-up.
CONDITIONS
Brief Title
2 Versus 6 Hour Oxaliplatin Infusions in Patients With Gastrointestinal Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Confirmed diagnosis of a gastrointestinal cancer
- Plan to receive 4 or more cycles of FOLFOX6 chemotherapy
- Histologically confirmed, measurable or evaluable disease
- Absolute neutrophil count (ANC) ≥ 1,500/µL without white blood cell growth factors
- Platelet count ≥ 75,000/µL (transfusion allowed up to 72 hours prior)
- Hemoglobin ≥ 8 g/dL (transfusion allowed up to 72 hours prior)
- Creatinine clearance > 30 mL/min by Cockcroft-Gault
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Signed informed consent
- Adequate birth control when appropriate
You will not qualify if you...
- Preexisting grade 2 or higher peripheral neuropathy
- Receiving anticancer therapies within 14 days before starting FOLFOX6
- Known intolerance or allergy to any FOLFOX6 agents or concurrent drugs
- Severe or uncontrolled medical conditions including unstable angina, symptomatic heart failure (NYHA class III or IV), recent myocardial infarction (≤ 6 months), serious arrhythmia, or other significant heart disease
- Active or uncontrolled severe infections or liver disease such as cirrhosis
- History of severe bleeding requiring ≥ 4 units of red blood cells within 48 hours
- History of non-compliance or inability to complete the study
- Participation in another investigational drug trial within 14 days prior to dosing
- Pregnant or nursing women
- Women of childbearing potential must use highly effective contraception during the study and for 8 weeks after; post-menopausal status or surgical sterilization confirmed as appropriate
Research Team
O
Olumide B. Gbolahan, MBBS, MSc
A
Amber Draper, PharmD
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