Phase II trial of gemcitabine in refractory germ cell tumors

Purpose: This phase II study was designed to determine the toxicity and act ivity of single-agent gemcitabine in heavily pretreated patients with germ cell tumors. Patients and Methods: From March 1996 through November 1997, 21 patients we re enrolled onto a phase II study of gemcitabine 1,200 mg/m(2), given on da ys 1, 8, and 15 every 4 weeks. One patient was unassessable because he neve r received any gemcitabine. Thirteen of 20 patients had received three prio r 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 nanhematologic toxicity (grade 3 nausea). Six of 20 patients had grade 3 le ukopenia. There were no episodes of granulocytopenic fever, and no patient required platelet transfusion. Three (15%)of 20 patients achieved an object ive response, including one complete remission. Three additional patients h ad a minor radiographic or serologic response. Conclusion: Gemcitabine had definite activity in this heavily pretreated ge rm cell tumor patient population. (C) 1999 by American Society of Clinical Oncology.