Recruiting
Phase 2

Oxaliplatin

Sponsor:

Emory University

Code:

NCT03800693

Conditions

Malignant Digestive System Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fluorouracil

Leucovorin

Oxaliplatin

Study Details

Brief summary:

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.

Conditions

Malignant Digestive System Neoplasm

Study ID

NCT03800693

Start date

Mar 14, 2019

Status verified date

Nov, 2025

Completion date

Sep 17, 2026

Anticipated

Primary completion date

Aug 5, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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
  • Absolute neutrophil count (ANC) ≥ 1,500/µL (no white blood cell growth factors allowed to meet requirement)
  • Platelets ≥ 75,000/µL (may be transfused up to 72 hours prior to day 1 to meet requirement)
  • Hemoglobin ≥ 8 g/dL (may be transfused up to 72 hours prior to day 1 to meet requirement)
  • Creatinine clearance > 30 mL/min by Cockcroft-Gault, to preserve similar dosing (85 mg/m²) for analysis
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
  • Signed informed consent
  • Adequate birth control when appropriate

Exclusion Criteria:

  • 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
  • Patients who have any known severe and/or uncontrolled medical conditions such as:

  • 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
  • Active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, or decompensated liver disease
  • Patients with any history of severe hemorrhage requiring ≥ 4 units of packed red blood cells (RBCs) in a 48-hour period
  • Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will not be able to complete the entire study
  • Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 14days prior to dosing
  • Pregnant or nursing (lactating) women
  • Women of childbearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must use highly effective methods of contraception during the study and 8 weeks after. Highly effective contraception methods include combination of any two of the following:

  • Use of oral, injected or implanted hormonal methods of contraception or;
  • Placement of an intrauterine device (IUD) or intrauterine system (IUS);
  • Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository;
  • Total abstinence or;
  • Male/female sterilization Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to randomization. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of childbearing potential

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Fluorouracil

Given IV

Leucovorin

Given IV

Oxaliplatin

Given IV

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 and Locations

Central contacts

Olumide B. Gbolahan, MBBS, MSc

404-778-0032ogbolah@emory.edu

Amber Draper, PharmD

amber.draper@emoryhealthcare.org

Locations

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Autumn Lunceford

404-686-1638patricia.autumn.lee.lunceford@emory.edu

Principal Investigator:

Olumide B. Gbolahan, MBBS, MSc

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Allyson Anderson

404-686-0239allyson.anderson@emory.edu

Principal Investigator:

Olumide B. Gbolahan, MBBS, MSc

Emory Saint Joseph's Hospital

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Alicia Escobar

678-843-7029alicia.m.escobar@emory.edu

Principal Investigator:

Olumide B. Gbolahan, MBBS, MSc

More Information

Sponsor

Emory University

Last update posted

Nov 6, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2025-11-06.