Chemotherapy With or Without Enoxaparin in Pancreatic Cancer

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

312

Participants

Timeline

Start Date

April 30, 2004

Primary Completion Date

January 31, 2009

Study Completion Date

June 30, 2009

Conditions
Pancreatic Cancer
Interventions
DRUG

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.

DRUG

chemotherapy with LMWH - enoxaparin

1-12 weeks: enoxaparin 1g/m², s.c. 12-PD or event: enoxaparin 0,4g s.c.

DRUG

only chemotherapy

observation, no treatment with LMWH

Trial Locations (1)

13353

Universitätsmedizin - Berlin - Charite, Berlin

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

collaborator

Amgen

INDUSTRY

collaborator

Eli Lilly and Company

INDUSTRY

lead

CONKO-Studiengruppe

OTHER

NCT00785421 - Chemotherapy With or Without Enoxaparin in Pancreatic Cancer | Biotech Hunter | Biotech Hunter