Pancreatic Cancer Clinical Trial
Official title:
A Prospective, Randomized Trial Of Simultaneous Pancreatic Cancer Treatment With Enoxaparin and ChemoTherapy (PROSPECT)
To evaluate the safety and efficacy of chemotherapy with or without enoxaparin. This study
is powered to decrease the DVT/ VTE events rate from 10% to 3% with enoxaparin in the
experimental arm.
N=540pts, dropout-rate 15%, power 80 %, two sided, significant level 5%
Approximately 20% of patients (pts) diagnosed with pancreatic adenocarcinoma (PA) develop
venous thromboembolism, which may contribute to the dismal prognosis of PA. A small phase II
trial suggested an improved survival by the addition of low molecular weight heparin (LMWH)
to chemotherapy. We conducted a small pilot study which indicated that the addition of
enoxaparin to chemotherapy GFFC chemotherapy is safe and feasible in pts with advanced PA.
Furthermore, results of several phase III studies suggest that pts in good performance
status may benefit from more intensive chemotherapy regimen (Riess et al; Heinemann et al;
ASCO 2005). Based on these considerations we started the multicenter phase III study CONKO
004.
540 patients are to be recruited into this study. Primary stratification takes place
according to Karnofsky performance status and kidney function. Patients with KPS > 80% and
normal kidney function 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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