312
Participants
Start Date
April 30, 2004
Primary Completion Date
January 31, 2009
Study Completion Date
June 30, 2009
enoxaparin
Patients receive GFFC +/- LMWH (gemcitabine 1 g/m2 (30 min), cisplatin 30 mg/m2 (90 min), 5-fluorouracil 750 mg/m2 (24 h), folinic acid 200 mg/m2 (30 min), d1, 8; q3w +/- Enoxaparin 1mg/kg daily s.c.). Pts with KPS \< 80 % and increased creatinin plasma levels (\>1.3 mg/dl) receive the current standard therapy (gemcitabine 1 g/m2 (30 min), d1, 8, 15; q4w) +/- LMWM +/- Enoxaparin 1mg/kg daily s.c. After 12 weeks of initial chemotherapy all patients who have not progressed received the standard therapy (gemcitabine mono) +/- Enoxaparin 40mg/d s.c.
chemotherapy with LMWH - enoxaparin
1-12 weeks: enoxaparin 1g/m², s.c. 12-PD or event: enoxaparin 0,4g s.c.
only chemotherapy
observation, no treatment with LMWH
Universitätsmedizin - Berlin - Charite, Berlin