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

• Status: Completed
• Trial end date: 2004-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CONKO-Studiengruppe
• Treatments: Calcium heparin; Dalteparin; Enoxaparin; Heparin; Heparin, Low-Molecular-Weight; Tinzaparin

Criteria

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)