Comparing 2-hour and 6-hour oxaliplatin infusions for gastrointestinal cancer treatment

Phase II Evaluation of the Effect of 2 Versus 6 Hour Oxaliplatin Infusions on Neuropathy and Pharmacokinetics in Patients With Gastrointestinal Cancers

This study is testing whether giving oxaliplatin over 2 hours instead of 6 hours can help people with gastrointestinal cancer experience less nerve damage while still getting effective treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Emory University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 3 sites (Atlanta, Georgia and 2 other locations)
• Trial ID: NCT03800693 on ClinicalTrials.gov

What this trial studies

This phase II trial investigates the effects of administering oxaliplatin over two different infusion durations (2 hours vs. 6 hours) in patients with gastrointestinal cancers. The primary objective is to assess the severity of sensory neuropathy using patient-reported outcomes at the start of the fourth treatment cycle. Secondary objectives include evaluating pharmacokinetic parameters and clinical outcomes such as therapy duration and dose adjustments. Patients are randomized into two groups to receive oxaliplatin along with leucovorin and fluorouracil, with the aim of minimizing nerve damage and maintaining chemotherapy efficacy.

Who should consider this trial

Good fit: Ideal candidates are patients with a confirmed diagnosis of gastrointestinal cancer who are planning to undergo at least four cycles of FOLFOX6 chemotherapy.

Not a fit: Patients with non-gastrointestinal cancers or those not eligible for FOLFOX6 chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could help patients tolerate chemotherapy better by reducing nerve damage, allowing for uninterrupted treatment.

How similar studies have performed: Other studies have explored similar infusion strategies, but this specific comparison of infusion durations is novel.

Eligibility criteria

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

Where this trial is running

Atlanta, Georgia and 2 other locations

• Emory University Hospital Midtown — Atlanta, Georgia, United States (Recruiting)
• Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States (Recruiting)
• Emory Saint Joseph's Hospital — Atlanta, Georgia, United States (Recruiting)

Study contacts

• Principal investigator: Olumide B. Gbolahan, MBBS, MSc — Emory University
• Study coordinator: Olumide B. Gbolahan, MBBS, MSc

Conditions Malignant Digestive System Neoplasm