CompletedPhase 1/2

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

Germany19 participantsStarted 2003-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: minimum of 3 months

Trial details

NCT IDNCT01945879

SponsorCONKO-Studiengruppe

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2004-04

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