Gemcitabine in advanced renal cell carcinoma. A phase II study of the National Cancer Institute of Canada Clinical Trials Group

Ann Oncol. 1993 Apr;4(4):331-2. doi: 10.1093/oxfordjournals.annonc.a058494.

Abstract

Background: Gemcitabine (2', 2'-difluorodeoxycytidine; dFdC) an anticancer agent with activity in preclinical models, was felt to be a promising new chemotherapy drug which warranted testing in patients with advanced renal cell carcinoma.

Methods: Eighteen patients with histologically proven metastatic or locally recurrent renal cell carcinoma and bidimensionally measurable disease were accrued to a phase II study of gemcitabine administered intravenously on days 1, 8 and 15 of a 28 day treatment cycle. Initial doses of gemcitabine were 800 mg/m2; doses in subsequent cycles were escalated to a maximum of 1250 mg/m2, toxicity permitting.

Results: One partial response was seen for a response rate of 6%. Hematologic toxicity was not severe with this dosing schedule; however, two patients developed dyspnea with bronchospasm after repeated injections of drug.

Conclusions: The dose and schedule of gemcitabine employed results in only a modest response rate in patients with advanced renal carcinoma. Investigators should be aware of the possibility of dyspnea and bronchospasm developing shortly after gemcitabine administration.

Publication types

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

MeSH terms

  • Adult
  • Aged
  • Antimetabolites, Antineoplastic / adverse effects
  • Antimetabolites, Antineoplastic / therapeutic use*
  • Carcinoma, Renal Cell / classification
  • Carcinoma, Renal Cell / drug therapy*
  • Carcinoma, Renal Cell / secondary
  • Deoxycytidine / adverse effects
  • Deoxycytidine / analogs & derivatives*
  • Deoxycytidine / therapeutic use
  • Female
  • Gemcitabine
  • Humans
  • Kidney Neoplasms / classification
  • Kidney Neoplasms / drug therapy*
  • Male
  • Middle Aged
  • Neoplasm Recurrence, Local / drug therapy

Substances

  • Antimetabolites, Antineoplastic
  • Deoxycytidine
  • Gemcitabine