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Trial record 10 of 2066 for:    Pancreatic Cancer AND Digestive System Neoplasms

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

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ClinicalTrials.gov Identifier: NCT03620461
Recruitment Status : Completed
First Posted : August 8, 2018
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Galician Research Group on Digestive Tumors

Brief 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.

Condition or disease Intervention/treatment
Metastatic Pancreatic Cancer 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.

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Study Type : Observational
Actual Enrollment : 210 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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
Actual Study Start Date : December 1, 2013
Actual Primary Completion Date : December 1, 2013
Actual Study Completion Date : June 30, 2015

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Gemcitabine - nabpaclitaxel
    efficacy and safety


Primary Outcome Measures :
  1. overall survival [ Time Frame: 2 years ]
    Evaluate overall survival (OS) in patients with metastatic pancreatic cancer receiving gemcitabine and nab-paclitaxel

  2. progression free survival [ Time Frame: 2 years ]
    Evaluate progression free survival (PFS) in patients with metastatic pancreatic cancer receiving gemcitabine and nab-paclitaxel

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.

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Responsible Party: Galician Research Group on Digestive Tumors
ClinicalTrials.gov Identifier: NCT03620461     History of Changes
Other Study ID Numbers: gitud
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Galician Research Group on Digestive Tumors:
metastatic pancreatic cancer
real world data
gemcitabine
nabpaclitaxel
efficacy
safety
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Albumin-Bound Paclitaxel
Paclitaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators