Status:
COMPLETED
Chemotherapy With or Without Enoxaparin in Pancreatic Cancer
Lead Sponsor:
CONKO-Studiengruppe
Collaborating Sponsors:
Sanofi
Amgen
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
To evaluate the safety and efficacy of chemotherapy with or without enoxaparin. This study is powered to decrease the DVT/ VTE events rate from 10% to 3% with enoxaparin in the experimental arm. N=54...
Detailed Description
Approximately 20% of patients (pts) diagnosed with pancreatic adenocarcinoma (PA) develop venous thromboembolism, which may contribute to the dismal prognosis of PA. A small phase II trial suggested a...
Eligibility Criteria
Inclusion
- histological or cytological pancreatic carcinoma, stage IV A, b
- no preceding radio or chemotherapy of the primarius or the reference lesions
- Karnofsky performance status ≥ 60%
- measurable tumor lesion by spiral CT or MRT not older than 14 days
- no deep venous thrombosis within the last 2 years
- patient compliance and geographical proximity of the residence, which make an adequate follow up possible
- sufficient bone marrow reserve: leukocyte ≥ 3.5 × 109 /l, thrombocyte ≥ 100 × 109 /l
- signed informed consent
- minimum age of 18 years
- women/men must provide sufficient pregnancy prevention
Exclusion
- preexisting indication for anti-coagulation of other reason
- bleeding in the last 2 weeks or increased bleeding risk (e.g. serious coagulating disturbance, active stomach or intestine ulzera, or had operational interferences in the last 2 weeks)
- body weight \< 45 kg and/or \> 100 kg
- pregnancy or insufficient preventing methods in the study process
- serious illness, which are incompatible with a study participation
- hypersensitivity to study drugs
- patients with serious kidney malfunction (Creatininclearance \< 30 ml/min)
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT00785421
Start Date
April 1 2004
End Date
June 1 2009
Last Update
January 8 2015
Active Locations (1)
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1
Universitätsmedizin - Berlin - Charite
Berlin, State of Berlin, Germany, 13353