An open label noncomparative phase II study of g

Authors: J T Hartmann K Oechsle J Huober A Jakob M Azemar M Horger L Kanz C Bokemeyer

Publish Date: 2005/08/17

Volume: 24, Issue: 3, Pages: 249-253

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Abstract

Background The number of effective cytotoxic agents for the treatment of patients with metastatic adult type soft tissue sarcoma STS is limited when patients have failed anthracylinebased chemotherapy The aim of this trial was to evaluate the efficacy of gemcitabine in this setting Methods Between August 2001 and March 2003 19 patients were eligible to enter Gemcitabine was administered as a 30minutes infusion at a dosage of 1 g/m2 on day 1 8 and 15 every 4 weeks All patients had progressive disease during n = 12 or shortly after an anthracyclinebased regimen n = 3 Results Four of 19 patients did not start study treatment because of fulminant progression Fifteen patients with a median age 47 years 32–72 were assessable All patients had received at least one prior treatment regimen range 1–6 for metastatic disease containing anthracyclines n = 15 and ifosfamide n = 11 To date a total of 72+ cycles have been applied median 3 1–28+ Seven patients 47 had progressive disease after completion of two cycles at the first response assessment One patient 6 attained a partial remission and 7 patients 47 achieved disease stabilisations One patient is still on treatment after more than 25 years The calculated progressionfree rate at 3 and 6 months was 467 CI95 214–719 and 133 CI95 0–305 95 of the cycles have been applied without any dose modification or treatment delay Conclusions Considering response and progressionfree rate as the primary endpoints for phase II trials in pretreated STS gemcitabine has moderate efficacy

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