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

Information source: CONKO-Studiengruppe
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pancreatic Cancer

Intervention: Enoxaparine (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: CONKO-Studiengruppe

Official(s) and/or principal investigator(s):
Uwe Pelzer, MD, Principal Investigator, Affiliation: Charité - Universitaetsmedizin Berlin

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.

Clinical Details

Official title: Pilot Study of Intensified Chemotherapy and Simultaneous Treatment With Heparin in Out-patients With Pancreatic Cancer.

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Incidence of NCI CTC Toxicity III°/IV° and severe bleedings

Secondary outcome: overall survival

Detailed description: The trial was a prospective, open-label, single center investigation in patients with inoperable pancreatic cancer who were treated with first-line chemotherapy in an outpatient setting. The intensified treatment consisted of gemcitabine 1g/m² (30 min), 5-flourouracil 750 mg/m² (24 h), folinic acid 200 mg/m² (30 min), and Cisplatin 30 mg/m² (90 min) on day 1 and 8; q3w). Beyond initial 3 months of intensified chemotherapy all patients without cancer progression received further treatment with gemcitabine alone to prevent patients from cumulative toxicities. The concomitant use of Enoxaparin started on day 1 of chemotherapy with a fixed dose of 40 mg daily until cancer progression. Dose adjustment for enoxaparin was recommended in patients with impaired kidney function or thrombocytopenia within the study according to National Cancer Institute Common Toxicity Criteria guidelines to minimize bleeding risk. Prophylactic antiemetic therapy and supportive care were provided according to individual symptoms and demand. The study used a sequential design to be able to stop the feasibility investigation in case of severe side effects. After inclusion of three consecutive patients a hold of recruitment was arranged until all three patients received at least 4 weeks of concomitant enoxaparin treatment. In absence of serious events the recruitment should be continued until a minimum of 15 patients received at least 12 weeks concomitant enoxaparin treatment. The trial was approved by the Scientific and Research Ethics Committee of our institution. The investigation was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice Guidelines. Furthermore, the national principles for the proper execution of the clinical examination of drugs ("Bundesanzeiger" No. 243 of 30. 12. 1987), the national regulations of the German drug law, and the German drug test guidelines were adhered.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Locations and Contacts

Charité - Universitätsmedizin Berlin, Berlin 13353, Germany
Additional Information

Starting date: January 2003
Last updated: September 16, 2013

Page last updated: August 23, 2015

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