Pancreatic Resectability in Cancers with Known Limited Extension (PRICKLE) - A single-centre phase 2a study of Gemcitabine plus Nab-paclitaxel for borderline unresectable locally advanced pancreatic cancer. - PRICKLE

Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge0 sites9 target enrollmentJune 19, 2014

Conditionsocally advanced pancreatic cancer MedDRA version: 17.0 Level: LLT Classification code 10033606 Term: Pancreatic cancer non-resectable System Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

DrugsAbraxane Gemcitabine

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: ocally advanced pancreatic cancer
Sponsor: Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
Enrollment: 9
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 19, 2014

End Date

October 26, 2017

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge

Eligibility Criteria

Inclusion Criteria

•Patients are eligible for inclusion in the study if they meet all of the following criteria:
•Patients with inoperable locally advanced pancreatic adenocarcinoma, defined as Category 2 by central radiological review.
•Aged 18 years or over at the time of signing the Informed Consent Form.
•Documented histological or cytological diagnosis of pancreatic ductal adenocarcinoma.
•ECOG performance status 0\-1\.
•Life expectancy of at least 12 weeks.
•Willing and able to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
•Adequate haematological function defined by:
•oAbsolute neutrophil count (ANC) \=1,500 cells/mm3 (1\.5 x 10 9/L).
•oHaemoglobin \=8\.0 g/dL (80 g/L) (may be increased to this level with transfusion as long as there is no evidence of active bleeding).

Exclusion Criteria

•Patients are to be excluded from the study if they meet any of the following criteria:
•Patients with metastatic PDAC, or disease which is amenable to resection with curative intent. These include tumours which are defined as Category 1 or 3 by central radiological review.
•Other invasive malignancies diagnosed within the last 5 years, with the exceptions of adequately treated localized cured prostate cancer, in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for three years or more and are deemed at negligible risk for recurrence, are eligible for the trial.
•Known allergy or hypersensitivity to ABX or GEM.
•Routine use of oral anti\-oxidant supplements: beta\-carotene, selenium, lutein, zeaxanthin, lycopene, pycnogenol, fernblock, omega\-3S, vitamin C, vitamin E, astaxanthin. If recent use, a washout period of 5 half\-lives is required.
•Patients with pre\-existent ischemic heart disease particularly those under active treatment for coronary disease, will be excluded from Sonuvue dynamic contrast enhanced ultrasound investigation due to sporadic reports of cardiac ischemia in this population. They will be eligible for the rest of the study, as long as their cardiac status does not preclude surgery.
•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 study. Examples include, but are not limited to:
•oPatients who have had a venous thromboembolic event (e.g., pulmonary embolism or deep vein thrombosis) requiring anticoagulation who are not appropriately anti\-coagulated or have had a NCI CTCAE (version 4\.0\) Grade 2 or greater bleeding episode in the 4 weeks before Day 1\.
•oPatients taking warfarin, unless it is possible for the patient to be switched to a low molecular weight heparin for the duration of the study
•oPatients with a significant history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months.