drugset / Trial / NCT01945879

Pilot Safety Trial of Chemotherapy and Use of Heparin in Patients With Pancreatic Cancer

NCT01945879

Phase 1/2 Completed 19 enrolled CONKO-Studiengruppe
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2003-01
Primary completion
2004-04
Completion
2004-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Enoxaparin sodium Other / unclassified 40 mg Subcutaneous