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Retrospective Analysis of 2nd-line Nab-Paclitaxel + Gemcitabine After 1st-line FOLFIRINOX in Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT04133155
Recruitment Status : Recruiting
First Posted : October 21, 2019
Last Update Posted : October 22, 2019
Sponsor:
Collaborators:
Bundang CHA Hospital
Ulsan University Hospital
Information provided by (Responsible Party):
Changhoon Yoo, Asan Medical Center

Brief Summary:
In this study, clinical data of patients who received 2nd-line Nab-paclitaxel plus Gemcitabine (nab-P+GEM) after progression on 1st-line FOLFIRINOX will be reviewed retrospectively.

Condition or disease Intervention/treatment
Pancreatic Cancer Metastatic Pancreatic Cancer Drug: nab paclitaxel plus gemcitabine

Detailed Description:
FOLFIRINOX is one of standard 1 st-line regimens for patients with advanced PDAC. However, there is no globally established 2 nd-line regimen after the failure of FOLFIRINOX. Although gemcitabine-based regimens are recommended by multiple guidelines and widely used in daily practice, further analysis is needed to reveal the magnitude of clinical benefit with these regimens. Nab-paclitaxel plus Gemcitabine (Nab-P+Gem) is another standard 1 st-line regimen for PDAC, but there are limited data as 2 nd-line therapy in PDAC. Therefore, the investigators are conducting a multicenter retrospective analysis of 2 nd-line nab-P+Gem after progression on FOLFIRINOX in patients with advanced PDAC.

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Study Type : Observational
Estimated Enrollment : 103 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Multicenter Retrospective Analysis for Efficacy and Safety of Second-Line Nab-Paclitaxel Plus Gemcitabine After Progression on 1st-line FOLFIRINOX in Advanced Pancreatic Ductal Adenocarcinoma
Actual Study Start Date : September 16, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2021


Group/Cohort Intervention/treatment
nab-P + GEM
Nab-paclitaxel plus gemcitabine
Drug: nab paclitaxel plus gemcitabine
Nab-paclitaxel 125 mg/m2 weekly for 3 weeks, every 4 weeks Gemcitabine 1000 mg/m2 weekly for 3 weeks, every 4 weeks
Other Name: Abraxane




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 1 year ]
    Time from the start of 2nd-line nab-P + GEM to disease progression or death from any cause, whichever came first


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 1 year ]
    Time from the start of 2nd-line nab-P+GEM to death from any cause

  2. Objective response rates [ Time Frame: 1 year ]
    Tumor response graded by Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1

  3. Toxicity profile [ Time Frame: 1 year ]
    Safety profile graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pathologically confirmed pancreatic ductal adenocarcinoma who received 2nd-line nab-paclitaxel plus gemcitabine after progression on 1st-line FOLFIRINOX
Criteria

Inclusion Criteria:

  • Pathologically confirmed pancreatic ductal adenocarcinoma
  • Administration of 2nd-line nab-paclitaxel plus gemcitabine
  • Progression on 1st-line FOLFIRINOX

Exclusion Criteria:

  • Pathologic diagnosis other than pancreatic ductal adenocarcinoma
  • Administration of nab-paclitaxel plus gemcitabine as 3rd or greater lines of therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04133155


Contacts
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Contact: Changhoon Yoo, MD +821099006798 cyoo.amc@gmail.com

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Contact: Changhoon Yoo, MD         
Principal Investigator: Changhoon Yoo, MD         
Sponsors and Collaborators
Asan Medical Center
Bundang CHA Hospital
Ulsan University Hospital
Investigators
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Principal Investigator: Changhoon Yoo, MD Asan Medical Center

Publications:
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Responsible Party: Changhoon Yoo, Assistant professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT04133155     History of Changes
Other Study ID Numbers: AX-NI-PANC-PI-13883
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Changhoon Yoo, Asan Medical Center:
Pancreatic cancer
FOLFIRINOX
nab-paclitaxel plus gemcitabine
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
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs