Clinical trial · Interventional
Pilot Safety Trial of Chemotherapy and Use of Heparin in Patients With Pancreatic Cancer
Pilot Study of Intensified Chemotherapy and Simultaneous Treatment With Heparin in Out-patients With Pancreatic Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Venous thromboembolic events are considered to be a prognostic negative factor and small studies showed astonishing survival advantages using heparin as prophylactic treatment to prevent venous thromboembolic events. Based on these assumptions our Charité - Onkologie (CONKO) study group planned to conduct a randomized trial to investigate the impact of low molecular weight heparin (LMWH) in a prospective setting in patients with advanced pancreatic cancer undergoing first line therapy, the CONKO-004 trial. During the preliminary stages we had to undertake a pilot trial to get information on safety and feasibility of combined chemotherapy with simultaneous treatment of the LMWH Enoxaparin in patients with advanced pancreatic cancer who are at high risk of gastrointestinal bleeding due to local cancer spread.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enoxaparine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GFFC + LMWH
- description
- gemcitabine/ 5-flourouracil/folinic acid/ cisplatin as chemotherapeutic treatment plus enoxaparine as experimental addition
- interventionNames
- Drug: Enoxaparine
Primary outcomes (1)
- measure
- Incidence of NCI CTC Toxicity III°/IV° and severe bleedings
- timeFrame
- minimum of 3 months
- description
- Incidence of NCI CTC Toxicity III°/IV° as well as severe bleedings for a minimum of 15 patients and an observation time of at least 3 months
Secondary outcomes (1)
- measure
- overall survival
- timeFrame
- at least 12 months of follow up
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ambulatory patients with histologically confirmed advanced adenocarcinoma of the pancreas * no previous radio- or chemotherapy * Karnofsky Performance Status (KPS) ≥ 60% * measurable tumour lesion confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) within the last 14 days * no VTE within the last 2 years * adequate compliance and home residence within geographical proximity to the particular department (allowing an adequate follow-up) * sufficient bone marrow function (leukocytes 3.5 × 109/l, thrombocytes 100 × 109/l) * age ≥ 18 years. Exclusion Criteria: * pre-existing indication for anticoagulation * major bleeding events within the last 2 weeks * severe impairment of coagulation * active gastrointestinal ulcers or major surgery within the last 2 weeks * body weight \< 45kg or \> 100kg * pregnancy/lactation or insufficient contraception during study * severely impaired renal function (creatinine clearance \< 30 ml/min)
References
Publications (1)
- DERIVEDPelzer U, Hilbig A, Stieler JM, Bahra M, Sinn M, Gebauer B, Dorken B, Riess H. Intensified chemotherapy and simultaneous treatment with heparin in outpatients with pancreatic cancer - the CONKO 004 pilot trial. BMC Cancer. 2014 Mar 19;14:204. doi: 10.1186/1471-2407-14-204. PMID 24641937