2 Versus 6 Hour Oxaliplatin Infusions in Patients With Gastrointestinal Cancers

NCT03800693 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: IRB00106610NCI-2018-02241Winship4468-18
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• 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

  The EORTC-CIPN-20 sub-scales will be computed according to the standard scoring algorithm and then transformed to a 0 to 100 scale, where high scores mean less symptom burden. The primary outcome measure of difference in sensory scores of the two groups between baseline and the initiation of cycle 4 will be the driver of the analysis.

  Baseline up to 60 days (course 4)

Secondary Outcomes (5)

• Maximum concentrations achieved (Cmax)

  At baseline and at 1, 2, 4, 6, 48, and 192 hours after initiation of oxaliplatin

• Changes in tumor size

  Up to 18 months after completion or discontinuation of chemotherapy

• Duration of therapy

  Up to 18 months after completion or discontinuation of chemotherapy

• Dose density

  Up to 18 months after completion or discontinuation of chemotherapy

• Frequency of dose holds or reductions

  Up to 18 months after completion or discontinuation of chemotherapy

Study Arms (2)

2-hour infusion group

ACTIVE COMPARATOR

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.

Drug: Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin

6-hour infusion group

EXPERIMENTAL

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.

Drug: Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin

Interventions

Fluorouracil DRUG

Given IV

Also known as: 5-FU, Carac, Ribofluor

2-hour infusion group; 6-hour infusion group

Leucovorin DRUG

Given IV

Also known as: Folinic acid

2-hour infusion group; 6-hour infusion group

Oxaliplatin DRUG

Given IV

Also known as: Eloxatin

2-hour infusion group; 6-hour infusion group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Emory University: lead
• Hematology/Oncology Pharmacy Association: collaborator
• University of Pittsburgh: collaborator

Study Sites (3)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

RECRUITING

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Fluorouracil; Leucovorin; Oxaliplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals

Study Officials

• Olumide B. Gbolahan, MBBS, MSc

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olumide B. Gbolahan, MBBS, MSc

CONTACT

404-778-0032; ogbolah@emory.edu

Amber Draper, PharmD

CONTACT

amber.draper@emoryhealthcare.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 11, 2019
• Study Start: March 14, 2019
• Primary Completion (Estimated): August 5, 2026
• Study Completion (Estimated): September 17, 2026
• Last Updated: November 6, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)