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

NCT01945879 | Completed Phase 1 DMC

• 1 other identifier: CONKO-004/1
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer

Keywords

pancreatic cancer; heparin; thromboembolic events; bleedings

Outcome Measures

Primary Outcomes (1)

• Incidence of NCI CTC Toxicity III°/IV° and severe bleedings

  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

  minimum of 3 months

Secondary Outcomes (1)

• overall survival

  at least 12 months of follow up

Study Arms (1)

GFFC + LMWH

EXPERIMENTAL

gemcitabine/ 5-flourouracil/folinic acid/ cisplatin as chemotherapeutic treatment plus enoxaparine as experimental addition

Drug: Enoxaparine

Interventions

Enoxaparine DRUG

al patients received additional low molecular heparin, if the safety cohort of three patients received at least 4 weeks of combined treatment without severe side effects, recruitment were continued until a minimum of 15 patients completed at least 3 months of treatment.

Also known as: low molecular weight heparin, clexane

GFFC + LMWH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• CONKO-Studiengruppe: lead

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 13353, Germany

Location

Related Publications (1)

• Pelzer 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 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Thromboembolism

Interventions

Enoxaparin; Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Uwe Pelzer, MD

  Charité - Universitaetsmedizin Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 5, 2013
• First Posted: September 19, 2013
• Study Start: January 1, 2003
• Primary Completion: April 1, 2004
• Study Completion: April 1, 2004
• Last Updated: September 19, 2013

Record last verified: 2013-09

Locations

DE (1)