A Phase II Study of Nab-paclitaxel and Gemcitabine, in Elderly Patients with Previously Untreated, Metastatic Pancreatic Adenocarcinoma

Asociación de Oncología Médica del Hospital de Cruces (ASONMEC)0 sites80 target enrollmentJanuary 16, 2015

Overview

No summary available.

Registry

who.int

Start Date

January 16, 2015

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Asociación de Oncología Médica del Hospital de Cruces (ASONMEC)

•1\. Histologically or citologically\-confirmed pancreatic adenocarcinoma
•2\. Stage IV disease (metastatic only)
•3\. No prior systemic therapy for their diagnosis (except in adjuvant setting \> six months previously)
•4\. ECOG performance status of 0\-1
•5\. Age \>\=70 years.
•6\. Evidence of either or both of the following:
•\- RECIST\-defined measurable disease (lesions that can be accurately measured in at least one dimension with the longest diameter \>\= 20mm using conventional techniques or \>\= 10 mm with spiral CT scan)
•\- An elevated serum CA19\-9 at baseline ( \>\= 2X ULN)
•7\. Female patients must be either surgically sterile or postmenopausal.
•8\. Male patients must be surgically sterile or must agree to use a condom during sex with women who may become pregnant while receiving the study drug and for 6 months after receiving the last dose.

•1\. Any prior systemic or investigational therapy for metastatic pancreatic cancer.
•2\. Inability to comply with study and/or follow\-up procedures.
•3\. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that, in the opinion of the investigator, renders the subject at high risk from treatment complications or might affect the interpretation of the results of the study.
•4\. Presence of central nervous system or brain metastases.
•5\. Life expectancy \< 12 weeks.
•6\. Pregnancy (positive pregnancy test) or lactation.
•7\. Prior malignancy except for adequately treated basal cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other form of cancer from which the patient has been disease\-free for 5 years.
•8\. Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.
•9\. Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
•10\. Known, existing uncontrolled coagulopathy.