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.
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 tumorpatient population.
Authors: Hans-Georg Kopp; Markus Kuczyk; Johannes Classen; Arnulf Stenzl; Lothar Kanz; Frank Mayer; Michael Bamberg; Jörg Thomas Hartmann Journal: Drugs Date: 2006 Impact factor: 9.546
Authors: M Mego; D Svetlovska; M Reckova; K Kalavska; J Obertova; P Palacka; K Rejlekova; Z Sycova-Mila; M Chovanec; J Mardiak Journal: Invest New Drugs Date: 2021-05-29 Impact factor: 3.850
Authors: G M Mead; M H Cullen; R Huddart; P Harper; G J S Rustin; P A Cook; S P Stenning; M Mason Journal: Br J Cancer Date: 2005-07-25 Impact factor: 7.640
Authors: C Kollmannsberger; O Rick; H Klaproth; T Kubin; H G Sayer; M Hentrich; M Welslau; F Mayer; M Kuczyk; C Spott; L Kanz; C Bokemeyer Journal: Br J Cancer Date: 2002-09-23 Impact factor: 7.640