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
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