Study on 2 Versus 6 Hour Oxaliplatin Infusions for Patients with Gastrointestinal Cancers

Sponsor: Emory University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03800693

Provider View

This clinical trial is exploring whether giving the chemotherapy drug oxaliplatin over a longer period (6 hours) can reduce nerve damage in patients with gastrointestinal cancers, compared to the standard 2-hour infusion.

Patient Parameters

Program Overview

The purpose of this study is to find out if extending the infusion time of the chemotherapy drug oxaliplatin to 6 hours can help prevent or delay nerve damage in patients with gastrointestinal cancers. Nerve damage is a common side effect of oxaliplatin, which can lead to delays or reductions in chemotherapy doses. By giving oxaliplatin over a longer period, the study aims to keep patients on their standard chemotherapy doses for longer without interruptions.

Description

The main goal of this study is to compare the severity of nerve damage in patients receiving oxaliplatin over 2 hours versus 6 hours. This will be measured using patient-reported outcomes on a specific scale for chemotherapy-induced nerve damage.

Secondary goals include:

  • Analyzing how the body processes oxaliplatin, including its concentration in the blood and how long it stays in the body.
  • Monitoring changes in nerve damage scores over the course of treatment.
  • Evaluating treatment outcomes such as how long patients stay on therapy, any dose reductions, and overall treatment delivery.
  • Investigating the relationship between oxaliplatin levels in the blood and nerve damage symptoms.

Participants will be randomly assigned to one of two groups:

  • 2-hour infusion group: Patients receive oxaliplatin and leucovorin intravenously over 2 hours, followed by a lower dose of fluorouracil over 2-4 minutes and a higher dose over 4-6 hours. This cycle repeats every 14 days unless the disease progresses or side effects become unacceptable.
  • 6-hour infusion group: Patients receive oxaliplatin over 6 hours, with leucovorin and fluorouracil given as in the 2-hour group. This cycle also repeats every 14 days unless the disease progresses or side effects become unacceptable.

After completing the study treatment, patients will have follow-up visits at 1, 3, 6, 12, and 18 months.

Eligibility Criteria

Inclusion Criteria

  • Must be in good general health with an ECOG performance status of 0 to 2.
  • Have a confirmed diagnosis of gastrointestinal cancer.
  • Plan to receive at least 4 cycles of FOLFOX6 chemotherapy, which includes fluorouracil, leucovorin, and oxaliplatin.
  • Have measurable or evaluable disease, with at least one measurable lesion if the cancer is advanced or metastatic.
  • Have adequate blood cell counts and organ function, including:
    • Neutrophil count of at least 1,500/µL.
    • Platelet count of at least 75,000/µL.
    • Hemoglobin level of at least 8 g/dL.
    • Creatinine clearance greater than 30 mL/min.
    • Total bilirubin level within 1.5 times the normal limit.
  • Must provide signed informed consent.
  • Use adequate birth control if applicable.

Exclusion Criteria

  • Have existing moderate to severe nerve damage.
  • Currently receiving or have recently received other cancer treatments within 14 days of starting FOLFOX6.
  • Known allergies to any components of the FOLFOX6 regimen.
  • Have severe or uncontrolled medical conditions, such as:
    • Unstable heart conditions or recent heart attack.
    • Severe infections or liver disease.
  • History of severe bleeding requiring significant blood transfusions.
  • History of not following medical advice or being unreliable in completing the study.
  • Participation in another clinical trial with an investigational drug within 14 days before starting the study.
  • Pregnant or breastfeeding women.
  • Women of childbearing potential must use effective contraception during the study and for 8 weeks after. Acceptable methods include hormonal contraception, IUDs, barrier methods, or sterilization. Women are considered not of childbearing potential if they are post-menopausal or have had surgical procedures like oophorectomy or tubal ligation.

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