Jane S. Ricciuti, RPh, MS


September 20, 2002

In This Article

Antineoplastic Agents

(oxaliplatin) Injection

Manufacturer/Distributor: Ben Venue Laboratories/Sanofi-Synthelabo

Drug Approval Classification: Original New Drug Application (Approval Date: 8/9/02)

Indication: Eloxatin (oxaliplatin), used in combination with infusional 5-fluorouracil/leucovorin (5-FU/LV), is indicated for the treatment of patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed during or within 6 months of completion of first-line therapy with the combination of bolus 5-FU/LV and irinotecan.

The approval of Eloxatin is based on response rate and an interim analysis showing improved time to radiographic progression. No results are available at this time that demonstrate a clinical benefit, such as improvement of disease-related symptoms or increased survival.

Eloxatin should not be administered to patients with a history of known allergy to oxaliplatin or other platinum compounds.

Dosing: The recommended dosing schedule given every 2 weeks is as follows:

Day 1: Eloxatin 85 mg/m2 IV infusion in 250-500 mL D5W and leucovorin 200 mg/m2 IV infusion in D5W both given over 120 minutes at the same time in separate bags using a Y-line, followed by 5-FU 400 mg/m2 IV bolus given over 2-4 minutes, followed by 5-FU 600 mg/m2 IV infusion in 500 mL D5W (recommended) as a 22-hour continuous infusion.

  • Day 2: Leucovorin 200 mg/m2 IV infusion over 120 minutes, followed by 5-FU 400 mg/m2 IV bolus given over 2-4 minutes, followed by 5-FU 600 mg/m2 IV infusion in 500 mL D5W (recommended) as a 22-hour continuous infusion.

  • Repeat cycle every 2 weeks.

  • The administration of Eloxatin does not require prehydration.

  • Premedication with antiemetics, including 5-HT3 blockers with or without dexamethasone, is recommended.

  • Clinical Summary: An interim analysis of a multicenter, randomized, 3-arm, controlled study in 821 patients comparing Eloxatin in combination with an infusional schedule of 5-FU/LV to the same dose and schedule of 5-FU/LV alone and to single-agent Eloxatin in patients with advanced colorectal cancer showed the combination resulted in a greater number of patients having tumor shrinkage and led to a delay in resumption of cancer growth. In 152 patients evaluated, there was a 9% partial response to the combination of Eloxatin plus 5-FU/LV vs 1% partial response in the Eloxatin-only group.

    At the time of the interim analysis, 49% of the radiographic progression events had occurred. In this interim analysis, an estimated 2-month increase in median time to radiographic progression was observed compared with infusional 5-FU/LV alone.

    Adverse Effects: The package insert for Eloxatin includes a platinum compound Black Box warning for anaphylactic/anaphylactoid reactions.

    Similar to other platinum compounds, Eloxatin has been associated with significant acute and persistent neuropathy:

    An acute, reversible, primarily peripheral sensory neuropathy that is of early onset occurs within hours or 1 to 2 days of dosing; it resolves within 14 days and frequently recurs with further dosing.

  • A persistent (lasting > 14 days), primarily peripheral, sensory neuropathy that is usually characterized by paresthesias, dysesthesias, hypoesthesias, but may also include deficits in proprioception, can occur, interfering with daily activities (eg, writing, buttoning, swallowing, and difficulty walking from impaired proprioception).

  • Potentially fatal Eloxatin-associated pulmonary fibrosis occurred in 0.7% of study patients.

    Common adverse reactions included peripheral sensory neuropathies, neutropenia, nausea, emesis, and diarrhea.

    Pharmacokinetics: Oxaliplatin is rapidly distributed into tissues or eliminated in urine at the end of a 2-hour infusion. Oxaliplatin is 90% protein bound, mainly to albumin and gamma-globulins. There is no evidence of cytochrome P-450-mediated metabolism. Oxaliplatin is renally excreted; renal clearance of unfilterable platinum is significantly correlated with the glomerular filtration rate. Caution is advised for the use of Eloxatin in patients with renal impairment.

    Eloxatin (oxaliplatin) Labeling


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