Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT03800693

2 Versus 6 Hour Oxaliplatin Infusions in Patients With Gastrointestinal Cancers

Led by Emory University · Updated on 2025-11-06

60

Participants Needed

3

Research Sites

392 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

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

Official Title

2 Versus 6 Hour Oxaliplatin Infusions in Patients With Gastrointestinal Cancers

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Emory University Hospital Midtown

Atlanta, Georgia, United States, 30308

Actively Recruiting

2

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States, 30322

Actively Recruiting

3

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States, 30342

Actively Recruiting

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Research Team

O

Olumide B. Gbolahan, MBBS, MSc

CONTACT

A

Amber Draper, PharmD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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