Phase
Condition
Adenocarcinoma
Treatment
Leucovorin
Nanoliposomal irinotecan
Oxaliplatin
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically proven metastatic adenocarcinoma of the pancreas
Progression documented after gemcitabine-Abraxane, or gemcitabine monotherapy
Signed written informed consent
Age ≥ 18
ECOG PS 0/1 at study entry
Measurable disease
Adequate renal (serum creatinine ≤ 1.5x upper reference range), liver (totalbilirubin ≤ 1.5x upper reference range) and hematopoietic functions (PMN ≥ 1,5x109/L, platelets ≥ 100x109/L, hemoglobin ≥ 9g/dl)
INR/PTT ≤ 1.5x ULN
Life expectancy of at least 12 weeks
Effective contraception for both male and female patients if the risk of conceptionexists during treatment and for one month after the last administration
Peripheral Neuropathy < grade 2
Exclusion
Exclusion Criteria:
Uncontrolled concurrent CNS, cardiac, infectious diseases, hypertension
History of myocardial infarction, deep venous or arterial thrombosis, CVA during thelast 6 months
Known hypersensitivity to any of the components, including excipients, of studytreatments
Previous malignancy in the last past 3 years except basal cell cancer of the skin orpreinvasive cancer of the cervix or carcinoma in situ of any type
Pregnancy or breast feeding
Medical or psychological conditions that would not permit the patient to completethe study or sign inform consent
Unstable angina, congestive heart failure ≥NYHA class II
Uncontrolled hypertension despite optimal management (systolic blood pressure >150mmHg or diastolic pressure > 90mmHg)
HIV infection
Complete DPD deficiency
Liver failure, cirrhosis Child Pugh B or C
Active chronic hepatitis B or C with a need for antiviral treatment
Brain metastasis
Major surgery, open biopsy or significant traumatic injury within 4 weeks prior tothe first dose of treatment
History of organ allograft
Ongoing uncontrolled, serious infection
Renal failure requiring dialysis
Patients receiving or having received any investigational treatment within 4 weeksprior to study entry, or participating to another clinical study
Study Design
Study Description
Connect with a study center
AZ St-Lucas
Brugge, West-Vlaanderen
BelgiumSite Not Available
UZ Antwerpen
Antwerp, 2650
BelgiumActive - Recruiting
AZ Imelda
Bonheiden,
BelgiumActive - Recruiting
Cliniques Universitaires Saint-Luc UCL
Brussels, 1200
BelgiumActive - Recruiting
ULB Erasme
Brussels, 1070
BelgiumActive - Recruiting
Grand Hopital de Charleroi
Charleroi,
BelgiumActive - Recruiting
AZ Maria Middelares
Ghent,
BelgiumActive - Recruiting
University Hospital Ghent
Ghent,
BelgiumActive - Recruiting
Pôle Hospitalier Jolimont (HELORA)
Haine-Saint-Paul, 7100
BelgiumActive - Recruiting
CHC MontLégia
Liège, 4000
BelgiumActive - Recruiting
AZ Sint-Maarten
Mechelen,
BelgiumSite Not Available
CHU Ambroise Paré
Mons,
BelgiumActive - Recruiting
CHR Namur
Namur,
BelgiumActive - Recruiting
AZ Turnhout
Turnhout, 2300
BelgiumActive - Recruiting
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