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A Prospective, Randomized Trial Of Simultaneous Pancreatic Cancer Treatment With Enoxaparin and ChemoTherapy (PROSPECT)

Phase 2/Phase 3
18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

A Prospective, Randomized Trial Of Simultaneous Pancreatic Cancer Treatment With Enoxaparin and ChemoTherapy (PROSPECT)

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

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.

Inclusion Criteria:

- histological or cytological pancreatic carcinoma, stage IV A, b

- no preceding radio or chemotherapy of the primarius or the reference lesions

- Karnofsky performance status ≥ 60%

- measurable tumor lesion by spiral CT or MRT not older than 14 days

- no deep venous thrombosis within the last 2 years

- patient compliance and geographical proximity of the residence, which make an
adequate follow up possible

- sufficient bone marrow reserve: leukocyte ≥ 3.5 × 109 /l, thrombocyte ≥ 100 × 109 /l

- signed informed consent

- minimum age of 18 years

- women/men must provide sufficient pregnancy prevention

Exclusion Criteria:

- preexisting indication for anti-coagulation of other reason

- bleeding in the last 2 weeks or increased bleeding risk (e.g. serious coagulating
disturbance, active stomach or intestine ulzera, or had operational interferences in
the last 2 weeks)

- body weight < 45 kg and/or > 100 kg

- pregnancy or insufficient preventing methods in the study process

- serious illness, which are incompatible with a study participation

- hypersensitivity to study drugs

- patients with serious kidney malfunction (Creatininclearance < 30 ml/min)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

DVT/TVE event rate

Outcome Time Frame:

After 12 events and after 24 events or after 540 pts recruited

Safety Issue:


Principal Investigator

Helmut Oettle, PD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CONKO Study Group


Germany: Ethics Commission

Study ID:




Start Date:

April 2004

Completion Date:

June 2009

Related Keywords:

  • Pancreatic Cancer
  • heparin
  • LMWH
  • pancreatic cancer
  • Pancreatic Neoplasms