Phase II trial of gemcitabine in refractory germ cell tumors

J Clin Oncol. 1999 Feb;17(2):509-11. doi: 10.1200/JCO.1999.17.2.509.


Purpose: This phase II study was designed to determine the toxicity and activity of single-agent gemcitabine in heavily pretreated patients with germ cell tumors.

Patients and methods: From March 1996 through November 1997, 21 patients were enrolled onto a phase II study of gemcitabine 1,200 mg/m2, given on days 1, 8, and 15 every 4 weeks. One patient was unassessable because he never received any gemcitabine. Thirteen of 20 patients had received three prior regimens, and 13 patients were platinum refractory (progression during or within 4 weeks of platinum treatment). There were five extragonadal cases and two patients with late relapse (relapse beyond 2 years).

Results: Gemcitabine was well tolerated. Only one patient had grade 3 or 4 nonhematologic toxicity (grade 3 nausea). Six of 20 patients had grade 3 leukopenia. There were no episodes of granulocytopenic fever, and no patient required platelet transfusion. Three (15%) of 20 patients achieved an objective response, including one complete remission. Three additional patients had a minor radiographic or serologic response.

Conclusion: Gemcitabine had definite activity in this heavily pretreated germ cell tumor patient population.

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

  • Adolescent
  • Adult
  • Antimetabolites, Antineoplastic / adverse effects
  • Antimetabolites, Antineoplastic / therapeutic use*
  • Deoxycytidine / adverse effects
  • Deoxycytidine / analogs & derivatives*
  • Deoxycytidine / therapeutic use
  • Female
  • Germinoma / drug therapy*
  • Germinoma / secondary
  • Humans
  • Male
  • Middle Aged
  • Ovarian Neoplasms / drug therapy*
  • Testicular Neoplasms / drug therapy*


  • Antimetabolites, Antineoplastic
  • Deoxycytidine
  • gemcitabine