metastatic pancreatic adenocarcinoma MedDRA version: 14.1 Level: LLT Classification code 10033605 Term: Pancreatic cancer metastatic System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Abraxane
Product Name: Nab-paclitaxel (paclitaxel formulated as albumin-bound nanoparticles)
Pharmaceutical Form: Powder for suspension for injection
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Aged = 18 years old • Signed informed consent and ability to comply with the protocol • Histologically or cytologically confirmed metastatic PDAC • 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 • Karnofsky performance status =70% • Life expectancy >12 weeks from the date of screening assessment • Adequate bone marrow function o Absolute neutrophil count (ANC) =1.5 x 10^9 /L o Haemoglobin (Hb) = 100 g/L o Platelets =100 x 10^9 /L o White blood cell count (WBC) = 3 x 10^9 /L • Adequate liver function o Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =2.5 x upper limit of normal range (ULN) o Total bilirubin 55 years, must have a negative serum or urine pregnancy test within 14 days prior to randomisation • All WCBP, all sexually active male patients, and all partners of patients must agree to use effective contraception methods throughout the study and for 30 days after the final dose of study drug for WCBP and for up to 6 months after treatment for male patients Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: The presence of any of the following will exclude patients: • Patients with operable or locally advanced PDAC • Other invasive malignancies diagnosed within the last 5 years, except non-melanoma skin cancer and localized cured prostate cancer • 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: o 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 o 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 o Patients with a history of interstitial lung disease, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis, cystic fibrosis or bronchiectasis o 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 o Patients with stable but significant cardiovascular disease defined by heart failure (New York Heart Association Functional Classification (NYHF) III or IV) or frequent angina o Presence of active infection o Cirrhotic liver disease, known chronic active or acute hepatitis B, or hepatitis C o Known allergy or hypersensitivity to GEM or ABX • Women who are pregnant, plan to become pregnant or are lactating • Use of oral anti-oxidant supplements: beta-carotene, selenium, lutein, zeaxanthin, lycopene, pycnogenol, fernblock, omega-3S, vitamin C, vitamin E, astaxanthin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to investigate the outcome of sequential administration of ABX combined with GEM (ABX/GEM) in patients with metastatic PDAC in terms of progression-free survival.;Secondary Objective: Secondary objectives are to evaluate the clinical aspects (including safety, response, and overall survival) and pharmacological differences between ABX/GEM administered concomitantly and sequentially; to assess quality of life (QoL) and health economics (HE) in both concomitant ABX/GEM and sequential ABX/GEM regimens; to explore biomarkers for identifying patient subgroups who are more likely to benefit from treatment using tumour tissue and blood samples collected prospectively.;Primary end point(s): The primary outcome measure is progression free survival.; Timepoint(s) of evaluation of this end point: Progression-free survival (PFS): PFS will be calculated from the date of randomisation to the date of clinical/radiological progression or death from any cause, whichever occurs first; surviving patients without progression will be censored at the date of their last clinical follow-up at the time of analysis. Progression is defined as ANY of the following: • Radiological progression according to RECIST version 1.1 • Death due to disease without prior objective documentation of progression • Global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression • Unequivocal progression of existing non-target lesions, in the opinion of the investigator (in this circumstance an explanation must be provided) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end point measures are safety, response, overall survival, quality of life and health economics. In addition, evaluation of pharmacological differences in scheduling of ABX and GEM will be undertaken to explore biomarkers for identifying patient subgroups more likely to benefit from treatment. ;Timepoint(s) of evaluation of this end point: These will be investigated at the end of the trial, which is when the last patient recruited has had follow-up for 12 months following their randomisation date. | — |
Countries
United Kingdom
Contacts
Public ContactKerry McKenna
Cambridge Unversity Hospitals NHS Foundation Trust
Outcome results
None listed