Randomised phase II trial to investigate two different schedules of nab-paclitaxel (Abraxane) combined with gemcitabine as first line treatment for metastatic pancreatic ductal adenocarcinoma

Overview

2017 Abstract results in http://ascopubs.org/doi/10.1200/JCO.2017.35.4_suppl.342 results abstract, 2017 Gastrointestinal Cancers Symposium 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36813867/ Results (added 24/02/2023)

Registry

who.int

Start Date

May 8, 2014

End Date

July 1, 2015

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. Aged \>\= 18 years old
•2\. Signed informed consent and ability to comply with the protocol
•3\. Histologically or cytologically confirmed metastatic PDAC
•4\. Radiologically confirmed stage IV disease and measurable disease by RECIST version 1\.1; baseline tumour assessments and measurements must be done within 28 days prior to randomisation
•5\. Karnofsky performance status \=70%
•6\. Life expectancy \>12 weeks from the date of screening assessment
•Adequate bone marrow function
•6\.1\. Absolute neutrophil count (ANC) \=1\.5 x 10^9 /L
•6\.2\. Haemoglobin (Hb) \= 100 g/L
•6\.3\. Platelets \=100 x 10^9 /L

•1\. Patients with operable or locally advanced PDAC
•2\. Other invasive malignancies diagnosed within the last 5 years, except nonmelanoma
•skin cancer and localized cured prostate cancer
•3\. Significant acute or chronic medical or psychiatric condition, disease or laboratory abnormality which in the judgment of the investigator would place the patient at undue risk or interfere with the trial. Examples include, but are not limited to:
•3\.1\. Patients who have had a venous thromboembolic event who are not appropriately anticoagulated or have had a significant bleeding episode in the 3 weeks prior to randomisation
•3\.2\. Patients with symptoms of severe chronic obstructive airways disease or significant shortness of breath at rest AND have an FEV1\<1\.0 L within the last 6 months
•3\.3\. Patients with a history of interstitial lung disease, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis, cystic fibrosis or bronchiectasis
•3\.4\. Patients with uncontrolled ischaemic heart or other cardiovascular event (myocardial infarction (MI), new angina, stroke transient ischaemic attack (TIA), or new congestive cardiac failure (CCF)) within the last 6 months
•3\.5\. Patients with stable but significant cardiovascular disease defined by heart failure (New York Heart Association Functional Classification (NYHF) III or IV) or frequent angina
•3\.6\. Presence of active infection