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Phase II Trial of Gemcitabine in Refractory Germ Cell Tumors

From the Department of Medicine, Division of Hematology/Oncology, Indiana University Medical Center, Indianapolis, IN.

Address reprint requests to Lawrence H. Einhorn, MD, Indiana Cancer Pavilion, 535 Barnhill Dr, Room 473, Indianapolis, IN 46202-5289

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.

Presented in part at the 34th Annual Meeting of the American Society of Clinical Oncology, Los Angeles, CA, May 16-19, 1998.

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