Phase II trial of arsenic trioxide in patients with metastatic renal cell carcinoma

Invest New Drugs. 2002 Aug;20(3):327-30. doi: 10.1023/a:1016270206374.

Abstract

Fourteen patients with metastatic renal cell carcinoma (RCC) were treated on a Phase II trial with arsenic trioxide (As2O3). Eligible patients had metastatic renal cell carcinoma with bidimensionally measurable disease, a Karnofsky performance status of at least 70%, life expectancy of greater than three months, and no evidence of brain metastases. Arsenic trioxide was given intravenously at a dose of 0.3 mg/kg/day for five consecutive days every four weeks. The most common toxicity observed was grade II elevation in liver function tests (36%), anemia (21%), renal insufficiency (14%), rash (7%), and diarrhea (7%). Best response was stable disease in 3 patients with one patient remaining on study at 8+ months At the dose and schedule used in this trial, arsenic trioxide did not achieve a complete or partial response in metastatic renal cell carcinoma.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / therapeutic use*
  • Arsenic Trioxide
  • Arsenicals / adverse effects
  • Arsenicals / therapeutic use*
  • Carcinoma, Renal Cell / drug therapy*
  • Carcinoma, Renal Cell / pathology
  • Disease Progression
  • Female
  • Humans
  • Karnofsky Performance Status
  • Kidney Neoplasms / drug therapy*
  • Kidney Neoplasms / pathology
  • Male
  • Middle Aged
  • Neoplasm Metastasis / pathology
  • Oxides / adverse effects
  • Oxides / therapeutic use*
  • Tomography, X-Ray Computed

Substances

  • Antineoplastic Agents
  • Arsenicals
  • Oxides
  • Arsenic Trioxide