Chemotherapy With or Without Enoxaparin in Pancreatic Cancer

Phase

2/3

Condition

Pancreatic Cancer

Digestive System Neoplasms

Pancreatic Disorders

Treatment

N/A

Clinical Study ID

NCT00785421

CONKO 004

CCT-NAPN-16752

Ages > 18
All Genders

Study Summary

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%

Eligibility Criteria

Inclusion

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 adequatefollow 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

Exclusion Criteria:

preexisting indication for anti-coagulation of other reason
bleeding in the last 2 weeks or increased bleeding risk (e.g. serious coagulatingdisturbance, active stomach or intestine ulzera, or had operational interferences inthe 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)

Study Design

April 01, 2004

June 30, 2009

Study Description

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.

Connect with a study center

Universitätsmedizin - Berlin - Charite
Berlin, 13353
Germany
Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.