A Phase II trial of edatrexate in patients with advanced renal cell carcinoma: An Eastern Cooperative Oncology Group Study

Robert Dreicer, Kathleen J. Propert, Timothy Kuzel, John M. Kirkwood, Peter J. O'Dwyer, Patrick J. Loehrer

Research output: Contribution to journalArticle

13 Scopus citations


We performed a Phase II trial of edatrexate in 44 chemotherapy-naive patients with advanced renal cell carcinoma. Prior therapy with one biological-response modifier was permitted. Most patients had multiple sites of metastatic disease and were considered to have a poor prognosis using Eastern Cooperative Oncology Group criteria. Edatrexate was administered intravenously at a dose of 80 mg/m2 weekly with 5 weeks of therapy considered one cycle. Oral cryotherapy using ice chips was administered before each edatrexate dose. Thirty-seven patients were eligible and evaluable for toxicity and response. Two patients obtained a partial response, for an overall response rate of 5.4% (95% confidence interval of 0.6%, 18.2%); one patient remained in remission at 26+ months. Three treatment-related deaths occurred. Toxicity was severe, with stomatitis, myelosuppression, and other gastrointestinal side effects most prominent. Edatrexate in this dose and schedule has minimal activity in advanced renal cell carcinoma and is toxic.

Original languageEnglish (US)
Pages (from-to)251-253
Number of pages3
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Issue number3
StatePublished - Jun 1 1997



  • Edatrexate
  • Renal cell carcinoma

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this