6-Hour Oxaliplatin in Preventing Nerve Damage in Patients with Advanced or Metastatic Gastrointestinal Cancer
18 Years and older, Male and Female
This phase II trial studies how well giving oxaliplatin over 6 hours works in preventing nerve damage in patients with gastrointestinal cancer that has spread to other places in the body. 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.
I. To determine the effect of 2 versus 6-hour oxaliplatin infusion time on the difference in severity of sensory 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 at the initiation of cycle 4.
I. Pharmacokinetic parameters of maximum concentration (Cmax), area under the curve (AUC), time of maximum concentration (tmax), clearance, and half life (t1/2) of platinum ultra-filtrate.
II. CIPN-20 sensory score changes over the duration of therapy as measured by a cumulative area-under-the curve score.
III. Clinical outcomes including duration of therapy, oxaliplatin dose reductions, delays in therapy, and overall dose intensity and delivery of oxaliplatin.
IV. Relationship between oxaliplatin Cmax, patient-reported acute neurotoxicity, and chronic neurotoxicity by CIPN-20 scores.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive oxaliplatin intravenously (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 46 hours on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive oxaliplatin IV over 6 hours on day 1. Patients also receive leucovorin and fluorouracil as in arm I. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1, 3, 6, 12, and 18 months.
- 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 should have at least one measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Absolute neutrophil count (ANC) >= 1,500/uL (no white blood cell growth factors allowed to meet requirement)
- Platelets >= 75,000/uL (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/m^2) for analysis
- Total bilirubin =< 1.5 x upper limit of normal (ULN)
- Signed informed consent
- Adequate birth control when appropriate
Treatment Sites in Georgia
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