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A Phase I study of oxaliplatin in cancer patients with impaired renal function

Li Liu, MD

University of Pennsylvania Cancer
Last Modified: May 13, 2001

Presenter: M.A. Graham
Affiliation: University of Texas Health Science Center, San Antonio

Background:

Oxaliplatin is a new platinum derivative with activity in several solid tumors, especially in some cisplatin/carboplatin-refractory neoplasms. Oxaliplatin clinical toxicity is also distinct from other platinum drugs: it has minimal renal toxicity and hematotoxicity. Therefore, oxaliplatin has been used in patients with impaired renal function. This study was designed to determine the recommended dose of Oxaliplatin in patients with renal dysfunction.

Materials and Methods:

• A total of 32 patients were included in this phase I study
• Dose escalation from 60-130 mg/m2 in three week cycles.
• The patients were grouped according to their 24 hour creatinine clearance (CrCl)

Results:

• Acute extremity or laryngeal dysesthesias, fatigue, mild nausea and a cumulative sensory neuropathy were the common side effects
• The toxicities were minimal
• Total plasma platinum clearance was positively related with CrCl

Authors' Conclusions

• Platinum clearance was associated with renal function
• The overall toxicity of oxaliplatin appeared to be minimal
• No dose reduciton is required for patients with mild to miderate renal insufficiency

Clinical/Scientific Implications:

• Dose-limiting toxicity of oxaliplatin is neurotoxicity, which is difficult to assess and may depend on the duration of use
• Long-term neurotoxicity needs to be studied and could be increased in patients with renal insufficiency