Gemcitabine and Nabpaclitaxel in Metastatic Pancreatic Carcinoma.

Metastatic Pancreatic Cancer Clinical Trial

— ANICE-PaC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03620461
• Other study ID #: gitud
• Status: Completed
• Start date: December 1, 2013
• Est. completion date: June 30, 2015

Study information

• Verified date: August 2018
• Source: Galician Research Group on Digestive Tumors
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: June 30, 2015
• Est. primary completion date: December 1, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Gemcitabine - nabpaclitaxel
efficacy and safety

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Galician Research Group on Digestive Tumors

Outcome

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