2 Versus 6 Hour Oxaliplatin Infusions in Patients With Gastrointestinal Cancers

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT03800693
Phase
PHASE2
Status
Recruiting
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Conditions

  • Malignant Digestive System Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fluorouracil — DRUG
    Given IV
  • Leucovorin — DRUG
    Given IV
  • Oxaliplatin — DRUG
    Given IV

Study Details

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.

Key Dates

Start date
Mar 14, 2019
Status verified
Nov 2025
Primary completion
Aug 5, 2026
Completion
Sep 17, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 2-hour infusion group
    Patients receive oxaliplatin IV and leucovorin IV over 2 hours on day 1. Patients also receive a lower dose of fluorouracil IV over 2-4 minutes followed by a higher dose IV continuous over 4-6 hours on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: 6-hour infusion group
    Patients receive oxaliplatin IV over 6 hours on day 1. Patients also receive leucovorin and fluorouracil as in the 2-hour infusion group. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

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 [ Time Frame: Baseline up to 60 days (course 4) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Emory Saint Joseph's HospitalAtlantaGeorgia30342
Alicia Escobar
[email protected]
678-843-7029
Olumide B. Gbolahan, MBBS, MSc (PRINCIPAL_INVESTIGATOR)
Emory University Hospital MidtownAtlantaGeorgia30308
Autumn Lunceford
[email protected]
404-686-1638
Olumide B. Gbolahan, MBBS, MSc (PRINCIPAL_INVESTIGATOR)
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322
Allyson Anderson
[email protected]
404-686-0239
Olumide B. Gbolahan, MBBS, MSc (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By research site
Emory Saint Joseph's Hospital· Atlanta, GAEmory University Hospital Midtown· Atlanta, GAEmory University Hospital/Winship Cancer Institute· Atlanta, GA

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