Gemcitabine and Nabpaclitaxel in Metastatic Pancreatic Carcinoma. (ANICE-PaC)

August 3, 2018 updated by: Galician Research Group on Digestive Tumors

Epidemiological, Observational, Retrospective and Multicenter Study to Evaluate the Characteristics of Treatment With Gemcitabine and Nab-paclitaxel in Patients With Metastatic Pancreatic Adenocarcinoma Treated in the First Line in Routine Clinical Practice. ANICE-PaC Study

Retrospective, multicenter study including pts with metastatic pancreatic cancer who started first-line treatment with napaclitaxel plus Gemcitabine between December 2013 and June 2015 according to the routine practice. Overall survival (OS) and progression-free survival (PFS) were assessed for the total sample and the exploratory subgroups based on treatment and clinical characteristics of the study pts.

Study Overview

Status

Completed

Conditions

Metastatic Pancreatic Cancer

Intervention / Treatment

Drug: Gemcitabine - nabpaclitaxel

Detailed Description

This observational, retrospective, multicenter study included patients with metastatic pancreatic adenocarcinoma (either recurrent or de novo) from 20 Spanish hospitals, who started first-line chemotherapy with nab-paclitaxel (Abraxane®, Celgene Europe Limited) plus gemcitabine between December 2013 and June 2015 according to routine clinical practice. The record included all adult patients (i.e., aged ≥ 18 years) with measurable metastatic disease at baseline in at least one dimension of the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1,[15] who received at least one dose of combined treatment with nab-paclitaxel plus gemcitabine. Data were retrieved from patients' medical records and lasted until death or the closure of the database on 16 March 2017. All patients signed the corresponding informed consent for their clinical data being used in this study, which was conducted in accordance with the local personal data protection law (LOPD 15/1999). The study protocol was approved by the local independent ethics committee.

Study Type

Observational

Enrollment (Actual)

210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients (i.e., aged ≥ 18 years) with measurable metastatic disease at baseline in at least one dimension of the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1,[15] who received at least one dose of combined treatment with nab-paclitaxel plus gemcitabine

Description

Inclusion Criteria:

Histologically-confirmed pancreatic adenocarcinoma or poorly differentiated carcinoma that is metastatic to distant sites.
Other histologies such as neuroendocrine and acinar cell carcinoma are excluded.
No prior chemotherapy for metastatic pancreatic cancer.
Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam.
Age greater than or equal to 18 years.
Patient has signed a Patient Informed Consent Form.
Patients should have received at least one cycle of gemcitabine and nabpaclitaxel

Exclusion Criteria:

less than one cycle of gemcitabine/nabpaclitaxel administrated.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Case-Only
Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival Time Frame: 2 years	Evaluate overall survival (OS) in patients with metastatic pancreatic cancer receiving gemcitabine and nab-paclitaxel	2 years
progression free survival Time Frame: 2 years	Evaluate progression free survival (PFS) in patients with metastatic pancreatic cancer receiving gemcitabine and nab-paclitaxel	2 years
Assess adverse events (per CTCAE v4.0 criteria) Time Frame: 2 years	Assess the adverse events (per CTCAE v4.0 criteria) associated with the use of gemcitabine and nab-paclitaxel in real world setting.	2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galician Research Group on Digestive Tumors

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

June 30, 2015

Study Registration Dates

First Submitted

June 4, 2018

First Submitted That Met QC Criteria

August 3, 2018

First Posted (Actual)

August 8, 2018

Study Record Updates

Last Update Posted (Actual)